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Genotropin HGH - Detailed Description

signs health and symptoms of low testosterone in males

Description:

Lyophilized Powdered Genotropin contains Recombinant-DNA [rDNA] derived somatropin. Somatropin is a polypeptide hormone comprised of a chain of 191 residues of amino acid, and it has a molecular weight o 22,124 daltons. Somatropin's sequence of amino acids is exactly the same as that of Human Growth Hormone which originates in the pituitary gland. Genotropin is created through a modification of a particular strain of E. coli to include the gene that is responsible for Human Growth Hormone. Genotropin comes in the form of a white, sterile powder, lyophilized and intended for injection subcutaneously.

Genotropin 1.5 milligram is administered using a 2-chambered cartridge. The front compartment holds 1.5 milligrams of rDNA-derived somatropin (about 4.5 IU), 27.6 milligrams of glycine, 0.3 milligrams or anhydrous sodium dihydrogen phosphate, and 0.3 milligrams of anhydrous disodium phosphate. The rear compartment holds 1.13 milliliters of water used for injection.

Genotropin 5.8 milligram is administered using a 2-chambered cartridge. The front compartment holds 5.8 milligrams of rDNA-derived somatropin (about 17.4 IU), 2.2 milligrams of glycine, 1.8 milligrams of mannitol, 0.32 milligrams of anhydrous sodium dihydrogen phosphate, and 0.31 milligrams of anhydrous disodium phosphate. The rear compartment holds 0.3 percent m-Cresol for use as a preservative, along with 45 milligrams of mannitol and 1.14 milliliters of water to be used for injection.

Genotropin 13.8 milligram is administered using a 2-chambered cartridge. The front compartment holds 13.8 milligrams of rDNA-derived somatropin (about 41.4 IU), 2.3 milligrams of glycine, 14.0 milligrams of mannitol, 0.47 milligrams of anhydrous sodium dihydrogen phosphate, and 0.46 milligrams of anhydrous disodium phosphate. The rear compartment holds 0.3 percent m-Cresol for use as a preservative, along with 32 milligrams of mannitol and 1.13 milliliters of water to be used for injection.

Genotropin Miniquick is administered by a one-time use syringe device that holds a 2-chambered cartridge. Genotropin Miniquick, ‘¢ can be attained in single doses varying from 0.2 milligrams to 2.0 milligrams in increments of 0.2 milligrams. The front compartment holds 0.22 to 2.2 milligrams of rDNA-derived somatropin (about 0.66 to 6.6 IU), 0.23 milligrams of glycine, 1.14 milligrams of mannitol, 0.05 milligrams of anhydrous sodium dihydrogen phosphate, and 0.027 milligrams of anhydrous disodium phosphate. The rear compartment holds 12.6 milligrams of mannitol in 12.6 milliliters of water to be used for injection 0.275 milliliters.

Genotropin is prepared in a highly purified manner. The recombinant reconstituted solution of somatropin has an pH of about 6.7 and an osmolality of about 300 mOsm/kg. Concentration of the somatropin solution is dependent upon the presentation and strength (read more in the section How Supplied).

Clinical Pharmacology

Clinical, preclinical, and in vitro tests show that Powdered Lyophilized Genotropin is equivalent to Human Growth Hormone that originates naturally in the pituitary in terms of therapeutic results.

The body reacts in a similar fashion to Genotropin as it does to the Human Growth Hormone created internally in the average adult. Genotropin therapy in child patients who suffer from a growth hormone deficiency (GHD) succeeds in stimulating normal growth and balances concentrations of Somatomedin-C/Insulin-like Growth Factor (IGF-1). Genotropin treatment in adults who are maligned with Growth Hormone Deficiency often results in a lower level of body fat, an increased amount of lean muscle mass, and changes in metabolism that include positive changes in the metabolism of lipids and the balance of concentrations of IGF-1.

Also, many other results have been shown through the administration of somatropin and/or Genotropin, including:

Tissue Growth

Skeletal System Growth: Genotropin has been shown to stimulate the growth of the skeletal system in young patients who suffer from Growth Hormone Disorder. There is a significant increase in the length of the body through the use of Genotropin that results from its effect upon the epiphyseal plates which develop inside the long bones. Serum levels of Insulin-Like Growth Factor-1, which likely play a part in the growth of the skeletal system, are found to usually be quite low in young patients suffering from Growth Hormone Disorder. These levels increase when the patient undergoes Growth Hormone Replacement Therapy with Genotropin. Higher serum concentrations levels of alkaline phosphatase also are seen with treatment.

Cell Growth: Research has shown that young, short-statured children have a lesser number of skeletal muscle cells because they have an insufficient level of natural Growth Hormone in comparison to the normal child population. Treatment with Genotropin leads to a boost in both the size and number of these muscle cells.

Protein Metabolism

Linear, normal growth in childhood is in part facilitated through an increase in the synthesis of cellular proteins. Retention of nitrogen, which is shown through a decrease in the excretion of nitrogen through urination, as well as through blood test measurements of nitrogen in the urea, is one of the many physiological changes that occur through Genotropin therapy.

Carbohydrate Metabolism

Children who suffer from hypopituitarism often also experience hypoglycemia when fasting, and this issue is also alleviated through Genotropin treatment, though excessive doses of Human Growth Hormone can lead to glucose intolerance.

Lipid Metabolism

In those who are deficient in Growth Hormone, Genotropin therapy has been shown to result in the mobilization of lipids, allowing for a reduction in storage of body fats and a higher level of fatty acid in the plasma.

Mineral Metabolism

Genotropin also can lead to a retention of phosphorus, potassium, and sodium. Concentrations of inorganic phosphate in the blood stream are also increased in those patients maligned with Growth Hormone Disorder who go through Genotropin Hormone Therapy. Levels of calcium in serum are not changed in a significant manner through the use of Genotropin, and Human Growth Hormone can lead to calciuria.

Body Composition

Adult patients who suffer from Growth Hormone Disorder that are treated with Genotropin at the suggested adult dosage (view Dosage and Administration for more information) show a decreased level of body fat and an increased level of lean muscle mass. These changes occur at the same time that the body begins to retain fluid more effectively. The result of all of this is that Genotropin has the ability to positively modify the composition of the body, and these positive changes can be sustained through continuing treatments.

Pharmakonetics

Absorption

After delivering a 0.03 milligram/killigram subcutaneous (abbreviated SC) thigh injection of 1.3 milligram/milliliter Genotropin to an adult patient with Growth Hormone Disorder, around 80% of the total dose was available for usage by the body in comparison to that available to the body through an intravenous dose. The results were similar in both female and male hormone replacement therapy patients, and a similar level of bioavailability has been shown in healthy male adult subjects as well.

In adult healthy males, after a subcutaneous thigh injection of 0.03 mg/kg, the extent of AUC absorption of a 5.3 mg/ml concentration of Genotropin proved to be 35% higher than that from 1.3 mg/mL Genotropin. The mean (plus or minus standard deviation) peak (max C) serum levels were 23.0 (plus or minus 9.4) ng/mL and 17.4 (plus or minus 9.2 ng/mL, respectively.

In another study of a similar kind with pediatric Growth Hormone Deficiency patients, dosage of 5.3 mg/mL Genotropin produced a mean area under the curve that happened to be 17% higher than the mean AUC for 1.3 mg/mL Genotropin. The mean max C levels were 21.0 ng/mL and 16.3 ng/mL respectively.

In yet another study, Adult GHD sufferers were administered two separate subcutaneous doses of 0.03 mg/kg Genotropin at a 1.3 mg/mL concentration. There was a 1-4 week period to washout between the injections. The mean max C levels were 12.4 ng/mL for the first administration and 12.2 ng/mL for the second injection, and this was reached at around 6 hours after the dose was received.

No data exists regarding bioequivalence between the 12 mg/mL dosage and the 1.3 mg/mL or the 5.3 mg/ml doses.

Distribution

The mean distribution volume of Genotropin after it has been administrated to adults with Growth Hormone Deficiency was figured to be about 1.3 (plus or minus 0.8) L/kg.

Metabolism

Genotropin is metabolized in through normal protein catabolism which occurs in both the kidneys and the liver. In the kidney cells, some of the products of Genotropin's breakdown are filtered back into the circulation of the system. The terminal mean half-life of Genotropin which is administered intravenously in a normal adult is around 24 minutes, but when Genotropin is administered subcutaneous, it has a half-life of 180 minutes in adults with Growth Hormone Disorder. This significant difference in half-life is due to the fact that when Genotropin is administered subcutaneous it absorbs into the body at a much slower rate.

Excretion

The mean of clearance or excretion of Genotropin which has been administered subcutaneously in a study of 16 adult subjects with Growth Hormone Disorder was 0.3 (plus or minus 0.11) L/hrs/kg.

Special Populations

Pediatric: Genotropin is broken down in adults in a similar manner as it is broken down in children.

Gender:There have been no studies that attempt to differentiate the difference in effect that Genotropin has between young boys and young girls, but it should be noted that Genotropin bioavailability has been found to be similar between adult female's undergoing Growth Hormone Replacement Therapy and Male Hormone Replacement Therapy patients in regard to Growth Hormone Deficiency.

Race:No research has been conducted with regard to whether race plays a factor in the pharmacokinetic results of Genotropin use.

Hepatic or renal insufficiency: There have been no research studies conducted in regard to Genotropin's effect on these particular populations of patients.

Table One

Average subcutaneous pharmacokinetic parameters of adult patients who are deficient in Growth Hormone.

Bio-availability

(percentage)

(Number of participants = 15) Max T

(Time [hours])

(Number of participants = 16) Clearance Rate

(Liters/hour ' kilogram)

(Number of participants = 16) Vol.Dis.

(Liters/kilogram)

(Number of participants = 16) T ©

(hours)

(Number of participants = 16)

Average 80.5 / 5.9 / 0.3 / 1.3 / 3.0

(± St.Dev.) * (± 1.65) (± 0.11) (± 0.80) (± 1.44)

95% CI 70.5 to 92 /. 5.0 to 6.7 / 0.2 to 0.4 / 0.9 to 1.8 / 2.2 to 3.7

Max T= Time that has elapsed when plasma concentration peaks

Clearance Rate = rate in which Genotropin is excreted from the body

Vol/Dis = distribution volume

T © = time that it takes the plasma concentration of Genotropin to reduce by half from its peak

St.Dev. = standard deviation

Cl = interval of confidence

Absolute Genotropin bioavailability has been estimated with the assumption that the data which has been transformed by log will follow a normal, standard distribution. The standard deviation and mean of the transformed were a mean of 0.22 and a standard deviation of plus or minus 0.241.

Clinical research with adult Growth Hormone Disorder patients

Lyophilized Genotropin Powder was tested along side a placebo in 6 clinical randomized trials which involved 172 adult Growth Hormone Disorder patients in total. The trials featured a six month treatment period which was double-blind in nature. During this period, 85 participants were administered Genotropin and 87 participants were administered a placebo. After this, an open-label period of treatment followed. During this period, patients who chose to participate were administered Genotropin for a period of time as long as 24 months.

Genotropin was injected subcutaneously each day with a dosage of 0.04 mg/kg dose of 0.04 mg/kg/wk during month one of treatment and in the subsequent months thereafter it was administered at 0.08 mg/kg/wk

After the six-month period of treatment, researchers looked for changes that were beneficial to the composition of the body for both the group that received Genotropin injections as well as the group which received injections of placebo. It was found that in the Genotropin group lean muscle mass, total water retention, and the ratio of lean/fat improved, while circumference of the waist and total mass of body fat reduced to more healthy levels. The effects of Genotropin on the composition of the body were retained with those who pursued treatment past the initial six month period. Mineral bone density began to decline after six months of treatment, but after twelve months of treatment the density values returned to baseline.

Usage and Indications

Lyophilized Genotropin Powder is designed for long-term therapy of pediatric patients that suffer from growth failure as a result of the inadequate production of endogenous Human Growth Hormone. It is not recommended for other causes of short stature.

Genotropin is also designed for long-term Growth Hormone Replacement Therapy for adults that suffer from a Growth Hormone Deficiency that is of either adult or childhood-onset in its etiology. Growth Hormone Disorder should be diagnosed through an appropriateGrowth Hormonestimulation test.

Contraindictions

Lypophilized Genotropin Powder should not be used if an individual shows any signs of neoplastic activity. Intracranial spade occupying lesions must be inert and antitumor treatment must be complete before Genotropin therapy begins. If the tumor begins to grow again, Genottropin treatment should be discontinued immediately. Also,Growth Hormoneshould no be administered as a means to promote growth in children who have fused epiphsys in the long bones.

Human Growth hormone treatments should not be administered to provide therapy for individuals who have an acutely critical illness stemming from abdominal or open heart surgery, multiple physical accidental trauma, or to those who have suffered acute respiratory failure.

A pair of clinical research trials involving 522 total adult participants that showed no signs of Growth Hormone Deficiency who suffered from these conditions were conducted. The results of these two studies revealed that there was a significantly higher incidence of mortality (41.9% vs. 19.3%) affecting those who were treated with somatropin (5.3 to 8 mg/day dosage) in comparison to those that merely received placebo (read Warningsfor more information).

Warnings

The 13.8 mg and 5.8 mg preparations of Lyophilized Genotropin Powder contain the preservative m-Cresol. Those who have a sensitivity or allergy to this preservative should not use these products. The Genotropin Miniquick and Genotropin 1.5 mg preparations do not have m-Cresol, or any preservative (Read the How Supplied section for more information).

Read the Contraindictions section for more information about increased mortality risk in those who suffer from critical illnesses in ICU because of complications due to abdominal or open heart surgery, multiple trauma due to an accident, or those who are suffering from acute respiratory failure. The proper research has not been established regarding the safety of continuing to undergo Growth Hormone Replacement Therapy for those who would be eligible for the treatment but also concurrently begin to suffer from the above ailments. For this reason, the possible benefits of Growth Hormone Replacement Therapy in those patients who are suffering from critical, acute injuries must be weighed against the possible risks of hormone treatment. The pros and cons of hormone replacement therapy must be properly evaluated.

Precautions: Is it time to think about stopping hormone replacement therapy?

General

Therapy with Lyophilized Genotropin Powder, should be guided by HRT doctors who have experience in the management and diagnosis of patients with Growth Hormone Disorder, as should be the case with the usage of any Growth Hormone preparation.

Caregivers and patients that will inject Genotropin in situations that are medically unsupervised are sternly advised to attain proper instruction and training about how to properly use Genotropin. This training should be given by a specialized doctor or other properly trained health professional.

Patients who suffer from Growth Hormone Disorder in addition to an intracranial lesion need to visit their doctor with regularity to monitor the development or recurrence of the underlying process of their disease. A survey of reports regarding the use of somatotropin replacement therapy shows no correlation between somatropin replacement therapy and tumors of the central nervous system. Later in life, there has been insufficient research to discover is there is any sort of causal relationship between the occurrence of Central Nervous System tumors and Somatropin Treatment

It is also vitally important that patients be carefully monitored for the formation of malignant lesions on the skin.

Caution is advised if Human Growth Hormone Therapy is administered to those that are already suffering from diabetes mellitus, because the level of insulin intake may need to be changed as a result of the hormone therapy. Those undergoing Growth Hormone Replacement Therapy should be monitored for the development of a glucose intolerance because Growth Hormone can sometimes give rise to a state where one is more resistant to insulin. Those patients that have a glucose intolerance or diabetes must be closely monitored while taking Genotropin. If major complications begin to arise it may be time to think about stopping hormone replacement therapy.

With those that have been diagnosed with hypopituitarism (a disease that is the result of multiple deficiencies of the hormonal system), the normal regimen of Hormone Replacement Therapy should be closely monitored when Genotropin treatment commences. Hypothyroidism can develop as one is treated with Genotropin, and as a result, inadequate medical response to hypothyroidism can cause Genotropin to become less effective or ineffective. For this reason, it is pertinent that patients get tested for proper thyroid function periodically, and if the thyroid becomes less active, thyroid hormone should also be administered in tandem with Genotropin.

Pediatric patients who have disorder of the endocrine system such as Growth Hormone Disorder have been shown to have a greater risk of developing a slipped capital femoral epiphyses. Any young patient that develops a limp or begins to complain of knee or hip pain as they undergo Growth Hormone Therapy needs to undergo evaluation.

Intracranial hypertension (IH) with nausea, vomiting, headache, visual disruption, and/or papilledema has been shown to be a side effect in a small minority of patients that take Growth Hormone therapies. These issues occur usually within the first two months after one begins GHT. In each reported case, and signs of Intracranial Hypertension are alleviated after hormone therapy is terminated or the dosage is adjusted to a more minute amount. Examination of the ocular fundus is recommended as a patient begins therapy, and it is also advised that they are examined for Intracranial Hypertension periodically as he or she continues Therapy.

Before undergoing adult treatment for Growth Hormone Deficiency, a patient who has undergone puberty and received GHRT in their childhood needs to be reevaluated in a manner that is recommended in the section Indications and Usage. If it is advisable to continue treatment, Genotropin therapy should continue at a lower level of dosage that is more appropriate for adults who have Growth Hormone Disorder.

Drug Interactions

Undergoing treatment with glucocorticoids concomitantly with Growth Hormone can cancel out the growth promotional effect of Hormone Therapy. Pediatric Growth Hormone deficiency patients that have a coexisting deficiency of ACTH aneed to have their dose adjusted carefully so that the glucocorticoid does not inhibit the effect of the Growth Hormone Replacement Therapy. For more information, see Precautions. Though there is limited published research on the subject, it has been indicated that in humans, GHT increases antipyrine evacuation mediated by CP450 (cytochrome P450). The available data seems to suggest that Growth Hormone administration can alter the evacuation of the compounds that become metabolized through the liver enzyme CP450. These compounds include sexual steroids, cyclosporine, anticonvulsants, and corticosteroids. It is advised that a patient undergo careful monitoring when Genotropin is injected in addition to other drugs that are metabolized by the liver enzyme CP450.

Mutagenesis, Carcinogenesis, and Fertility Issues with Human Growth Hormone Replacement Therapy

Studies of carcinogenicity have yet to be conducted in regard to bio identical Human Growth Hormone. A number of tests have shown no evidence of the mutagenicity of Human Growth Hormone. The tests conducted include the Ames Test in which gene mutations are introduced to bacteria, mutation of genes in mammalian cellular cultures grown in vitro (L5178Y cells), and damage to the chromosomes of intact animals (rat marrow cells). To learn more about issues regarding fertility, go to the section entitled Pregnancy.

Pregnancy Category B

Fertility studies enacted in regard to Genotropin at dosage levels of 0.3, 1, and 3.3 milligrams per kilogram per day delivered subcutaneously to rats and dosage levels of 0.08, 0.3, and 1.3 milligrams per kilogram per day delivered intramuscularly to rabbits resulted in a reduction in the body weight of the mother but the reduction was not teratogenic. The highest administered doses were about 24x and 19x the normal human levels for therapy, respectively, based upo the surface area of the body.

Rats received subcutaneous doses of Genotropin during gametogenesis and through the initial seven days of pregnancy at a rate of 3.3 mg/kg/day. This level is about 24x higher than the normal human dosage. This dosage produced extended cycles of estrous in females (known as anestrus), and fewer, less motile sperm in male rats. When Genotropin was administered to female, pregnant rats during days one through seven of gestation at 3.3 mg/kg/day, a modest increase of fetal mortality occurred. When administered 1 mg/kg/day (which is around 7x the normal human dose) rats displayed estrus cycles which were only slightly extended. At a dosage of 0.3 mg/kg/day there were no noted effects.

In postnatal and perinatal study of rats, doses of Genotropin at 0.3, 1, and 3.3 mg/kg/day resulted in the promotion of growth of the dams but not of the fetuses, themselves. Young rats exposed to 3.3 mg/kg/day were discovered to have an increase in weight gain during the suckling period, but these effects were no longer apparent at ten weeks old. There were no negative effects observed during morphogenesis, gestation, lactation, parturition, postnatal continued development, or the fertility of the offspring as a result of Genotropin. It is important to note, however, that there have been no adequate, well-conducted studies of pregnant women in regard to Genotropin. Studies regarding animal reproduction do not always correctly predict the equivalent human response to the same stimulus, therefore, Genotropin should only be used during pregnancy if it is clearly and absolutely needed.

Mothers who are nursing

No studies have been conducted with regard to Genotropin and nursing mothers. At this point it is not clear whether the drug is present in human milk. Since it is a fact that a number of drugs are released in human milk, caution must be exercised with the administration of Genotropin to a nursing female.

Bioidentical hormone replacement therapy side effects

As with all drugs that are protein-derived, a small minority of patients can begin to manufacture antibodies to the administered protein. Growth Hormone antibody with a lower binding than 2 mg/L has not been shown to be associated with the attenuation of growth. In those cases where the capacity for binding is greater than 2 mg/L, antibodies sometimes interfere with the desired results for growth.

In a survey of 419 pediatric GHT patients which were administered Lyophilized Genotropin powder, 244 were previously treated with Genotropin and 175 were undergoing GHT for the first time. Baseline presence of Anti-Growth Hormone antibodies had developed in 6 patients who were previously treated with Genotropin. 3 of those 6 once again tested negative for anti-Growth Hormone antibodies during six to twelve months of Genotropin treatment. Out of the rest of the group (413 patients), 8 (1.9% of the population) acquired detectable levels anti-Growth Hormone antibodies during Genotropin treatment. None of these antibodies reached a binding capacity of greater than 2mg/L. As a result, the patients who tested positive for Human Growth Hormone antibodies experienced no hindrance to Genotropin's intended growth response.

Genotropin preparations do contain trace amounts of periplasmic E. coli peptides (abbreviated PECP). Antibodies resistant to PECP develop in a small minority of those treated with Genotropin, but these antibodies do not create any issues of significance.

Clinical Genotropin studies with pediatric Growth Hormone Deficient patients uncommonly reported the following side effects: burning and pain around the administration site, nodules, inflammation, fibrosis, rash, bleeding, or skin pigmentation. Other side effects include headache, hypothyroidism, lipoatrophy, hematuria, and mild hyperglycemia.

There have been a limited number of reports of leukemia among young patients who have undergone GHT including pituitary-derived Growth hormone and Bio-Synthetic somatropin. The correlation, if any, between GHT and leukemia is unclear at this time.

In a survey of clinical Genotropin trials in 1,145 adults with Growth Hormone Deficiency, the most reported side-effect was mild or moderate fluid retention resulting in hypoesthesia, paresthesia, myalgia, peripheral edema, stiffness and pain in the extremities, peripheral swelling, and arthralgia. The previous side effects were noted early in Genotropin Therapy and they often subsided with time or disappeared with a reduction in dosage.

Table 2 shows side effects reported by five percent or more of adult patients with Growth Hormone Deficiency in a variety of clinical trial settings and after a number of different Genotropin treatment durations. Also corresponding rates of side effect incidence are listed for those who underwent placebo treatment during the six-month portion of double-blind clinical trials.

Table 2

Side effects reported by greater than or equal to 5 percent of a total of 1,145 Growth Hormone Deficient adult patients who participated in clinical administration of placebo and Genotropin, arranged by treatment duration, double-blind, and open-label phase. Percentages are rounded to the nearest 0.5%

Genotropin

Side-effects

Placebo Patients

0-6 months

n = 572

# Genotropin Patients

0-6 months

number of participants = 573

Percentage patients six-twelve months

n = 63

Percentage of patients twelve-eighteen months

n = 63

Percentage of patients eighteen-twenty four months

n = 60

Percentage Patients Reporting Side Effect

Peripheral Swelling 5.0 / 17.5* / 5.5 / 0 / 1.5

Infection of the upper respiratory tract 14.5 / 15.5 / 13.0 / 15.0 / 13.5

Arthralgia 4.0 / 17.0* / 7.0 / 6.5 / 3.5

Extremity stiffness 6.0 / 15.0* / 6.5 / 1.5 / 3.5

Tingling sensation 1.0 / 9.5* / 2.0 / 3.0 / 0

Peripheral edema 2.5 / 11.0* / 3.0 / 0 / 0

Extremity Stiffness 1.5 / 8.0* / 2.5 / 1.5 / 0

Headache 8.0 / 10.0 / 6.0 / 0 0

Pain reported in back 4.5 / 3.0 / 3.5 / 5.0 / 5.0

Muscle pain 1.5 / 5.0 * / 2.0 / 5.0 / 7.0

Fatigue 4.0 / 6.0 / 4.5 / 6.5 / 1.5

* Significant increase in comparison to those taking placebo. P n =

# of patients that received treatment in the specific period.

% = Patient percentage who experienced the side effect in the specific period.

In expanded study which occurred post-trial, diabetes was reported in twelve out of a total 3,031 patients as they were treated with Genotropin, only 0.4$ of the population. Each of the twelve patients showed risk factors for diabetes such as significant obesity or high levels of glycated hemoglocin, before beginning Genotropin Treatment. Out of that same pool of 3,031 Genotropin-receiving patients, only 2% (61) developed carpal tunnel symptoms, and this number dropped by 52 after treatment interruption or dosage adjustment, and the other nine found their symptoms alleviated by surgery. Other side effects that were reported in the study included hypoesthesia and general edema.

Overdose

Little information is available regarding chronic or acute overdosage of Lyophilized Genotropin Powder. Growth Hormone adminstered intravenously has shown evidence that it results in a severe decrease in the plasma of the blood. For this reason, hyperglycemia sometime occurs as a result. It is hypothesized that this same issue could occur in the rare instance where a very high dose of Genotropin is administered subcutaneously. Overdosage over the long term could result in hormone imbalance symptoms and signs of acromegaly that are consistent with the nature overproduction of Human Growth Hormone. Make sure to engage in safe hormone replacement therapy.

Administration and Dosage

The appropriate dosage of Lyophilized Genotropin Powder is dependent upon the individual needs of the patient. The dosage for the week ideally is divided into six or seven SC injections. The injection of Genotropin can be administered to the abdomen, buttocks, or thigh. The area where the subcutaneous injection occurs should change each day so that lipoatrophy is averted.

For Pediatric Growth Hormone Deficiency patients, a dosage of 0.16 to 0.24 milligrams per kilogram of body weight per week is generally the recommended dosage.

For Adult Growth Hormone Deficiency Patients, the initial recommended dose when one begins therapy is generally not greater than 0.04 mg/kg/week. Every four to eight weeks, the dosage can be increased as needed for the patient up to a max of 0.08 mg/kg/week dependent upon the patient's tolerance for the treatment. Response to the medicine, developed side effects, and levels of age-adjusted Insulin-Like Growth Factor-1 in serum can all be used to provide a guide leading to a proper titration of dosage. This regimen tends to lead to larger weight-adjusted treatment for woman than men, and smaller weight-adjusted treatment for obese and older patients.

Do not inject Genotropin intravenously.

Genotropin is provided in a two-chambered cartridge, with the lyophilized powder located in the front compartment and a dilutant located in the rear compartment. A reconstitution device mixes the dilutant and the powder.

Each device has its own directions to follow for proper reconstitution. It is vital that the medicine is not shaken, because shaking can lead to denaturation of the primary ingredient.

Before injection, all parenteral medicinal products need to be visually inspected for discoloration and particulate matter, if the container and solution permit. If the solution has become cloudy, it is vital that the contents are not injected.

Caregivers and patients that will administer the Genotropin in situations in situations where they are not medically supervised are urged to visit one of many bioidentical hormone physicians other appropriately qualified health professionals in order to acquire the appropriate instruction and training regarding the proper administration of Genotropin.

Storage and Stability

Except in proceeding situation, store Lyophilized Genotropin Powder in refrigeration at 2-8 degrees Celsius (36-46 degrees Fahrenheit). Refrain from freezing. Store in a light-protected area.

The 1.5 mg Genotropin Cartridge contains a dilutent without a preservative. After the drug is reconstituted, a cartridge can be stored safely for up to a day. Use it only once and throw away any solution that remains.

The 13.8 and 5.8 mg Genotropin cartridges contain a dilutent that is laced with a preservative. For this reason, these cartridges may be stored in refrigeration as long as three weeks.

The Genotropin Miniquick Growth Hormone Delivery Device needs to be refrigerated before it is dispensed, but it can be placed in storage at a temperature of 25 degrees Celsius (77 degrees Fahrenheit) or less for a period of as long as 3 months after it is dispensed. The dilutent does not contain preservative. After the Genotropin Miniquick has been reconstituted, it may be placed in storage under refrigeration for up to one day before usage. After it is used one time it should be discarded.

How Supplied

Lyophilized Genotropin Powder is available for purchase in the following configurations:

1.5 milligram two-chambered cartridge (without preservative)

mg/mL concentration (about 4 IU/mL)

Preconfigured in a Genotropin Intramix GH Reconstitution Device which is packaged with a single pressure release needle

Five Cartridge Package National Drug Code 0013-2606-94

5.8 milligram two-chambered container (added preservative)

5 mg/mL concentration (about 15 IU/mL)

Intended for usage with the Genotropin Mixer GH Reconstitution device and/or the Genotropin Pen 5 GH Delivery Device

Five Cartridge package National Drug Code 0013-2626-94

One Cartridge package National Drug Code 0013-2626-81

Preconfigured in a Genotropin Intramix GH Device for Reconstitution and packaged with one needle which functions through pressure release.

Package of five National Drug Code 0013-2616-94

Package of one National Drug Code 0013-2616-81

13.8 milligram two-chambered container (added preservative)

12 mg./mL concentration (about 36 IU/mL)

Intended for usage with the Genetropin Mixer GH Reconstitution device and/or the Genotropin Pen 12 GH Delivery Device

Box of Five National Drug Code 0013-2646-94

Box of One National Drug Code 0013-2646-81

Genotropin Miniquick GH Delivery Device contains a two-compartment cartridge containing a two-chamber cartridge of GENOTROPIN (no preservative)

After it is reconstituted, every Genotropin Miniquick released a 0.25 mL fixed dose without regard to strength. It is available in the proceeding strengths in packages of seven.

0.2 milligram National Drug Code 0013-2649-02

0.4 milligram National Drug Code 0013-2650-02

0.6 milligram National Drug Code 0013-2651-02

0.8 milligram National Drug Code 0013-2652-02

1.0 milligram National Drug Code 0013-2653-02

1.2 milligram National Drug Code 0013-2654-02

1.4 milligram National Drug Code 0013-2655-02

1.6 milligram National Drug Code 0013-2656-02

1.8 milligram National Drug Code 0013-2657-02

2.0 milligram National Drug Code 0013-2658-02

16 May 2012

Saizen HGH - Detailed Description

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Description:

Saizen is a Human Growth Hormone somatropin injection derived from recombinant DNA technology. Saizen is comprised of 191 residue amino acids and has a molecular weight 22,125 daltons. The sequence of Saizen's amino acids is completely identical to the sequence of Human Growth Hormone derived naturally from the pituitary. Saizen is created from a specific lab strain of the E. coli bacteria as a precursor chemical that consists of the recombinant Human Growth Hormone molecule that is preceded by a signal for secretion that originates with a protein from the E. coli bacteria. This precursor chemical is then directed to the plasma membranes of the cells. After the E. coli secretion signal is eliminated, the native protein is deposited into the periplasm and the protein begins to be folded correctly as it is synthesized.

Saizen is a pristinely purified preparation. The biological potency of Saizen is configured through a cell proliferation bioassay. Upon expiration, Saizen will not contain more than 15% deamidated GH upon its expiration. Deamidated Growth Hormone has been studied extensively, and it has been proven to be safe and completely active.

Saizen is a sterilized liquid that is intended to be administered with a subcutaneous injection. Saizen is almost isotonic at a 5mg GH per mL concentration. It has a pH value of around 6.0.

Every 2 mL container of Saizen holds 10mg (about 30 IU) of somatropin formulated in 17.4 mg NaCl, 4 mg polysorbate 20, 5 mg phenol, and 10mM sodium citrate.

Clinical Pharmacology

General Information

In vivo and in vitro clinical and preclinical testing have provided ample evidence that Saizen is equivalent therapeutically to Human Growth Hormone naturally derived from the pituitary. Children who do not secrete adequate Growth Hormone levels endogenously, patients who suffer from renal insufficiency that is chronic in nature, and patients who are maligned with Turner syndrome all report benefits when taking Nutropin or Saizen [injectable somatropin derived from recombinant DNA]. Patients who took Nutropin or Saizen were found to experience an increase in their rate of growth and also an increase in their IGF-1 (insulin-like growth factor-I) levels in a manner than is also seen when normal Human Growth Hormone levels are naturally produced by the pituitary gland.

Benefits that have been shown through studies regarding Saizen, somatrem, somatropin, and/or Human Growth Hormone derived naturally from the pituitary include:

A. Tissue Growth --

1) Skeletal Growth: Growth Hormone stimulates skeletal growth in

young patients that experience growth failure as a result of inadequate secretion of natural Growth Hormone, or as a secondary effect of chronic kidney insufficiency or also with patients that suffer from Turner syndrome. Growth of the long bones of the skeleton is a result of the expansion of the epiphyseal plates that are located on the ends of the growing bone. The metabolism and growth of the cells of the epiphyseal plates are stimulated directly by Growth Hormone and Insulin-Like Growth Factor-1, an important stimulator of Growth Hormone. Levels of IGF-1 in the blood serum are low in adolescents and children who are deficient in GH, but their levels increase when treated with Growth Hormone. In these young patients, new bone begins to develop through the epiphyses after Growth Hormone and IGF-1 have been introduced to the body. As one reaches the end of puberty, the growth plates fuse and adult height is locked in.

2) Cell Growth: Human Growth Hormone leads to an increase in both the size and number of skeletal muscle cells.

3) Organ Growth: Growth Hormone has a direct effect on the size of the internal organs, including the kidneys. It also increases the mass of red cells. Growth Hormone Treatment of genetic dwarf or hypophysectomized rats leads to organ development that is in proportion to the growth of the rest of the body. In healthy rats that were induced with uremia through nephrectomy, Growth Hormone promoted body and skeletal growth.

B. Protein Metabolism€”Proper growth is stimulated in part by protein synthesis which is encouraged by Growth Hormone. This is shown through retention of nitrogen that is demonstrated by a lower level of nitrogen excreted through the urine, as well as clinical testing for nitrogen in the blood urea which occurs during Growth Hormone Therapy.

C. Carbohydrate Metabolism€”Growth Hormone is a significant controlling mechanism in charge of carbohydrate. In patients that do not adequately secrete Growth Hormone, hypoglycemia is often experienced during periods of fast. This issue is largely resolved with Human Growth Hormone Therapy. It is a possibility that Growth Hormone therapy can lead to a decrease in the body's sensitivity to insulin. Patients who are not treated for chronic kidney insufficiency and/or Turner syndrome have a higher risk to develop intolerance to glucose. Human Growth Hormone treatment provided to children or adults has resulted in an increase in postprandial insulin levels and serum fasting. These two results happen most commonly with those that are overweight or obese. Also, postprandial glucose, mean fasting, and hemoglobin A 1c levels stay within a normal range.

D. Lipid Metabolism€”In patients who are Growth Hormone Deficient, Growth Hormone Therapy led to the mobilization of lipids, a reduction in stores of body fat, increased fatty acids entering the plasma, and lower levels of cholesterol in the plasma.

E. Mineral Metabolism€”Use of Growth Hormone leads to the retention of potassium in the body. This retention apparently is due to the enhanced cell growth that begins to occur. Inorganic phosphorus levels in the blood serum can sometimes increase modestly among patients who undergo Growth Hormone Therapy because they do not produce enough Growth Hormone on their own, have a chronic kidney deficiency, or suffer from Turner syndrome, because Growth Hormone enhances the metabolic processes associated the growth of bone in addition to improving tubular reuptake of phosphate by the kidneys. Serum calcium levels do not change significantly among these patients. Retention of sodium also occurs. Adults that developed a Growth Hormone Deficiency as children display low levels of bone mineral density (Acronym: BMD). (See also Precautions: Laboratory Tests.)

F. Connective Tissue Metabolism€”Growth Hormone chondroitin sulfate synthesis and collagen synthesis in addition to encouraging the urinary expulsion of hydroxyproline.

Pharmacokinetics

Absorption after Subcutaneous Injection€”The total bioavailability of recombinant Human Growth Hormone after being injected subcutaneously into a healthy adult male is determined to be 81 plus or minus 20%. The terminal mean t ½ after subcutaneous injection is much longer than the terminal mean after intravenous injection (2.1 plus or minus 0.43 hr vs. 19.5 plus or minus 3.1 min). This indicates that subcutaneous injection of Growth Hormone causes the compound to be released slowly and at a more modest rate.

Distribution€”Recombinant Human Growth Hormone Animal Research has shown that Growth Hormone is attracted to organs that are highly perfused, in particular the kidneys and the liver. The distribution volume at steady state for Recombinant Human Growth Hormone in a healthy adult male is around 50 mL/kg of body weight, essentially the serum volume.

Metabolism€”Both the kidney and liver have been proven to be essential organs for the proper metabolism of Growth Hormone. Animal research provides evidence that the kidneys are the primary organs of clearance. Growth Hormone filtration occurs at the glomerulus and Growth Hormone is reabsorbed by the proximal tubules. After that it is split inside the renal cells into its component amino acids, after which the acids return to normal circulation.

Elimination--The terminal mean t ½ after intravenous injection of recombinant Human Growth Hormone adult males in good health is approximated to be 19.5 plus or minus 3.1 minutes. Elimination of recombinant Human Growth Hormone after intravenous injection among healthy children and adults is shown to range from 116-174 mL/hr/kg.

Formulation bioequivalence€”Saizen [somatropin injection derived from recombinant DNA] has been shown to be the bioequivalent of Nutropin [somatropininjection derived from recombinant DNA]. This is based upon statistical evaluation of Area Under the Curve (AUC) and man C.

Special Populations

Pediatric€”Current research data suggests that there is no difference in bio identical Human Growth Hormone clearance between children and adults.

Gender€”There is no data available for exogenously injected recombinant Human Growth Hormone. The data that has been collected regarding methionyl rhGH, naturally produced and extracted pituitary Growth Hormone, and endogenous Growth Hormone produce no evidence that suggests that men and women eliminate Growth Hormone at different rates.

Geriatrics€”The limited amount of published research shows that Growth Hormone plasma clearance and normal steady-state Growth Hormone plasma concentration do not appear to be different among young and elderly populations.

Race€”The half-life values for endogenous Growth Hormone in healthy black males is not shown to be any different than the half-life values of Growth Hormone for healthy white males. There is no available data regarding other races.

Growth Hormone Deficiency (GHD)€”The reported values regarding the clearance of recombinant Human Growth Hormone in children and adults suffering from GHD range from 138-245 mL/hr/kg. These values are similar to those that occur in healthy children and adults. The terminal mean t ½ values following subcutaneous and intravenous administration in pediatric and adult Growth Hormone Deficiency patients have also proven to be similar to the values observed in the population of healthy adult males.

Kidney Insufficiency€”Adults and children who suffer from end-stage renal disease (ESRD) and chronic renal failure (CRF) to clear rhGH at a lower rate than healthy individuals. Endogenous Growth Hormone production can sometimes increase in particular individuals suffering from ESRD. Even so, no accumulation of recombinant Human Growth Hormone has been shown in children with ESRD of CRF that are given normal Growth Hormone Replacement Therapy.

Turner Syndrome€”No pharmacokinetic data is currently available regarding Turner syndrome and Growth Hormone Therapy. It has been reported, however, that absorption, half life, and clearance rates for internally produced Growth Hormone for this population show little difference when compared to the rates of healthy patients and patients only suffering from Growth Hormone Deficiency.

Hepatic Insufficiency€”A reduction in recombinant Growth Hormone clearance has been reported in patients that are suffering from extreme liver dysfunction. The clinical significance of this data is still unknown.

Research on the effectiveness of Saizen

Effect of the Bio-synthetic hormone Nutropin [recombinant DNA derived somatropin for injection] upon Growth Failure as a result of CRI

Two randomized, controlled, multi-center clinical trials were conducted in an effort to determine whether Nutropin treatment before renal transplantation in patients suffering from chronic renal insufficiency could possibly lead to an improvement in growth rate and a decrease in height deficit. One of the studies was a placebo-controlled, double-blind trial and the other trial was randomized and open-label. In both of these controlled studies, participants took a Nutropin dose of 0.05 mg/kg/day (0.35 mg/kg/wk). These doses were given daily by means of subcutaneous injection. Taking data from both studies of patients who underwent treatment for two full years resulted in 62 participants who received Nutropin treatment and 28 participants who were either untreated or treated by placebo. The year one mean growth rate was 10.8 cm/yr for patients treated with Nutropin, as compared with a mean growth rate of 6.5 cm/yr for the untreated/placebo controls (P&lt;0.00004) The year two mean growth rate was 7.8 cm/yr for the group treated with Nutropin, as compared with 5.5 cm/yr for the control group (p&lt;0.00005). A significant increase was revealed in the mean standard deviation (SD) of height score with the group that was administered Nutropin (baseline=-2.9, Month 24=-1.5, n=62), but there was no change worthy of significance in the control group (baseline=-2.8, Month 24=-2.9, n=28). The year three mean growth rate of 7.6 cm/year in those treated with Nutropin (n=27) provides evidence that Nutropin can stimulate growth for longer than two years, but there is no year three control data because after two years patients who were previously on control began taking Nutropin treatment, themselves. The height gains were also accompanied by proper advancement of skeletal age. The data demonstrates that Nutromin hormone therapy enhances the growth rate and alleviates that acquired height deficiency that is associated with CRI. At this time there is not enough data to scientifically show the benefits of continuing treatment longer than three years. It is hypothesized that final height is improved through the use of Nutropin therapy, but the exact effect that the drug has on final adult height has yet to be studied appropriately.

Growth after Transplantation

There is a famous study by NAPRTCS that has produced data regarding growth after transplant in pediatric patients who didn't receive Growth Hormone. The average SD score for change in height during the first two years after the transplant was received was 0.18 (300 total patients, Journal of Pediatrics 1993;122:397-402).

Controlled studies of Growth Hormone treatment administered to combat short stature that accompanies CRI were not underwent to compare the growth rates of untreated and treated patients after they underwent renal transplant. Even so, the growth data is available from a small subset of the patients that were followed for a minimum of 11 months. Among the 7 control patients, 4 had a higher SD height score and three showed either no change of significance or a decrease in their SD height score. Among the 13 patients that received Nutropin [somatropin for injection derived from recombinant DNA] before their transplant displayed either no change of significance or an increased SD height score post transplantation. This indicates that the gains that were achieved with Growth Hormone Therapy before th renal transplant were maintained post-transplantation. The deficit between the heights of the treated and untreated group narrowed as time passed after renal transplant.

Turner Syndrome

One multi-center, concurrently controlled, open-label, long-term randomized study, two multi-center, historically controlled, open-label, long-term studies, and one randomized, dose-response, long-term study were conducted to test the efficacy of Growth Hormone in treating girls who have short stature as a result of Turner syndrome.

In the randomized GDCT study which compared patients treated with Growth Hormone to a concurrent control group that did not receive Growth Hormone, the Growth Hormone-treated patients received a dosage of 0.3 mg/kg/wk 6 times each week. The mean age of the participants was 11.7 years and the duration of treatment was a mean of 4.7 years. The group that received therapy reached a mean height of 146.0 (n=27) as they reached near final height. The control group reached a near final height of only 142.1 cm (n=19). Through covariant analysis, the total effect of Growth Hormone therapy was an increase on mean height of 5.4 cm (p value=0.001).

In two of these studies, (85-044 and 85-023), the result of long-term Growth Hormone treatment (0.375 mg/kg/wk either daily or three times weekly) on final height upon adulthood was figured through a comparison of the final adult height of patients treated with Growth Hormone matched by age with historical controls of Turner syndrome patients who received no therapy to promote growth. In Study 85-023, oestrogen replacement therapy was not given until the patients reached the age of 14. Growth Hormone therapy led to an adult mean height gain of 7.4 cm (duration mean of Growth Hormone therapy=7.6 years) when compared to matched historical controls through covariant analysis.

In Study 85-044, patients that received Growth Hormone therapy early were randomly assigned to receive therapy to replace estrogen (through the use of conjugated estrogen, initial dose 0.3 mg, escalated over time to 0.625 daily) at either age twelve or fifteen. When compared to matched, historical controls, early Growth Hormone therapy (mean duration of Growth Hormone therapy=5.6 years) in combination with ERT and age twelve had a total adult height gain ot 5.9 cm (n=26). Those girls who initiated ERT at age fifteen (mean duration of Growth Hormone therapy=6.1 years) had a mean total adult height gain of 8.3 cm (n=29). Patients that began Growth Hormone therapy after age 11 (mean age 12.7 years, mean duration of Growth Hormone therapy=3.8 years) produced a mean total height gain of 5.0 cm (n=51).

So, in both study 85-023 and study 85-044, the most significant increase in adult height was shown in patients that received Growth Hormone treatment early along with ERT after age fourteen.

In a dose-response, blinded, randomized study, GDCI patients were treated from an average age of 11.1 for an average duration of 5.3 years with a dose of either 0.27 mg/kg/wk or 0.36 mg/kg/wk injected either three or six times per week. The average near final height of the patients that received growth hormone was 148.7 cm (n=31). This number represents a mean increase in adult height of around 5 cm in comparison to the observation of those girls historically that had untreated Turner syndrome.

In these research studies, patients with Turner syndrome (n=181) that were treated until they reached fully grown height gained a statistically marked average height gain with a range from 5.0-8.3 cm.

Adult Growth Hormone Deficiency (GHD)

Two placebo-controlled, double-blind, multi-center clinical trials were conducted with Nutropin [somatropin injection derived from recombinant DNA] in adults who have Growth Hormone Deficiency. One of the studies was conducted regarding adult-onset Growth Hormone Deficiency, with a mean age of 48.3 years and 166 participants. The dosage was 0.0125 or 0.00625 mg/kg/day at doses of 0.00625 mg/kg/day. Dose levels of 0.025 mg/kg/day were not tolerated by these participants. A second research study was conducted with regard to subjects with childhood-onset Growth Hormone Disorder who had previously been treated with Human Growth Hormone. The mean age was 23.8 years old and there were 64 total participants. They were randomly given assigned to take doses of 0.025 or 0.0125 mg/kg/day. These studies were designed to learn more about the effects of Growth Hormone Replacement therapy and its effect on body composition.

Hormone replacement therapy and weight loss

Marked changed in body composition (i.e., trunk percentage fat mass, total body percentage lean mass by DEXA scan, and total body percentage fat mass) from baseline to one year of treatment were shown in all Nutropin groups in both studies (p&lt;0.0001 for the change from the baseline and in relationship to the placebo). There was no statistically marked change that was seen in either group that was given placebo. In the study that dealt with adult-onset GHD, the Nutropin group decreased in total mean body fat from 35.0% to 31.5%, and the mean of trunk fat decreased from 33.9% to 29.5%, and the mean total lean body mass increased from 62.2% to 65.7%. The placebo group experienced mean changes less than or equal to 0.2% (p=insignificant). Because of the possibility that Growth Hormone-induced retention of fluids can possibly have an effect on DEXA lean mass measurements, DEXA scans were given again around three weeks after therapy was completed; the mean percentage lean body mass in the Nutropin participants averaged 65%, which was a change of 2.8% in regard to baseline, as compared to a 0.4% chance in the group that received placebo (p&lt;0.0001 between the two groups).

In the childhood-onset GHD study, the group that took a higher dose of Nutropin decreased their total mean body fat from 38.4% to 32.1%, average trunk fat from 36.7% to 29.0%, and average lean body mass from 59.1% to 65.5%; the group that took a low dose of Nutropin decreased total mean body fat from 37.1% to 31.3%, decreased mean trunk fat from 37.9% to 30.6%, and average lean body mass increased from 60.0% to 60.0%. The group that received placebo experienced mean changes of less than or equal to 0.6% (insignificant p).

In the study of adult-onset GHD, significant decreases in levels of LDL (bad) cholesterol and the ratio of LDL:HDL over the course of the initial year of treatment were found in the Nutropin patients in comparison with the placebo patients (p&lt;0.02). No statistically marked difference was discovered between the control group and the experimental group in regard to changes in triglycerides or HDL cholesterol in the first year of treatment. In the childhood-onset GHD study, significant drops in year one of LDL cholesterol, total cholesterol, and the ration of LDL to HDL cholesterol in comparison to the placebo group were only seen in the group that took a high dose of Nutropin (p&lt; 0.05). There was no statistically significant difference between groups in regard to triglycerides or HDL cholesterol in the first year of treatment.

Quality of life, physical endurance, and muscle strength measurements were not abnormal in a significant manner at baseline, and Nutropin had no no statistically significant effect on these three factors in these three studies.

Indications and Usage

Among Pediatric Patients

Saizen [somatropin injection derived from recombinant DNA] is meant for the long-term therapy of inadequate growth due to an inefficient level of endogenous Human Growth Hormone secretion.

Saizen [somatropin injection derived from recombinant DNA] is also meant for the therapy of inadequate growth as a result of CRI until renal transplantation occurs. Saizen treatment can and should be used in tandem with medical management of CRI

Saizen [somatropin injection derived from recombinant DNA] is also intended for as a long-term therapy to combat short stature that is a symptom of Turner syndrome.

Among Adult Patients

Saizen [somatropin injection derived from recombinant DNA] is intended to be a replacement for endogenous Growth Hormone in patients that have adult GHD and who meet the following criteria concurrently:

Diagnosis of adult Growth Hormone Deficiency displayed through a less than optimal response to a biochemical test of standard GH stimulation (peak Growth Hormone&lt;/=5 g/L)

and

In those with adult-onset: Patients that have either adult Growth Hormone Deficiency only, or have hypopituitarism because of trauma, radiation therapy, surgery, hypothalamic disease, or pituitary disease.

or

In those with childhood-onset: Patients that had a Growth Hormone deficiency during childhood that was confirmed in adulthood before undergoing Saizen HRT.

Hormone Replacement Therapy Contraindications

Saizen should not be prescribed as therapy for patients that have a critical acute illness that is due to complications after abdominal or open heart surgery, multiple trauma due to an accident, or acute respiratory failure. Two clinical trials controlled by placebo among non-GHD adult patients (n-522) that had these conditions showed a significant increase in rate of mortality (41.9% vs. 19.3%) among those patients that were treated with somatropin doses of 5.3-8 mg/day in comparison to those who were treated with placebo (for more information, see Warnings).

Saizen also should not be administered to promote growth in pediatric patients that have closed epiphyses.

Saizen should be avoided by patients that have active neoplasia. If neoplasia develops during treatment, Growth Hormone Therapy should be discontinued.

Warnings

View Contraindicationsto see more information regarding higher rates of mortality in patients who take Growth Hormone in addition to being treated for acute critical illness in ICU as a result of complications after abdominal or open-heart surgery, multiple trauma as a result of an accident, or acute respiratory failure. It has not been established if it is safe to receive replacement doses of Growth Hormone treatment for approved indications after concurrently developing the above afflictions. For this reason, the possible benefits of continuing Saizen treatment while also dealing with an acute critical illness should be discussed in terms of potential risk. Make sure you discuss your desires to undergo such a treatment with one of our many highly qualified bioequivolent hormone replacement therapy doctors here at Bio-Identical Hormone Replacement Therapy MD. We are always here and happy to answer any questions you may have. Call us, email us, or drop by!

Precautions

General: Saizen must be prescribed by a bioidentical hormones doctor who is experienced in the management and diagnosis of patients with Growth Hormone deficiency, CRI, or turner syndrome. There have been no completed studies regarding Saizen treatment and those that have undergone renal transplants. Also, at this time there is no research regarding the treatment of patients that have functioning renal allographs.

There is limited research regarding prolonged recombinant Human Growth Hormone treatment in adults.

Elderly Use: Clinical research studies of Saizen have yet to include sufficient numbers of participants age 65 or older to test as to whether they respond differently than younger patients. Clinical practitioners have not reported any difference between the responses of younger patients and the elderly, however. As a point of caution, dosage selection for elderly patients should be modest, generally beginning at the low level of the range of dosage, especially since the elderly have a higher frequency of decreased cardiac, renal, and hepatic function, along with other concomitant diseases and other drug therapies.

Those patients with closed epiphyseal plates who start Growth Bio Identical Hormones Therapy when in childhood need to be re-evaluated in accordance with the criteria listed in the Indications and Usage section before they continue to undergo Growth Hormone Therapy at a lower dosage level that is required to maintain proper hormone levels in Growth Hormone Deficient adults.

Saizen can reduce sensitivity to insulin, therefore patients need to be properly monitored for glucose intolerance.

In patients that suffer from diabetes mellitus, the insulin dosage may need to be adjusted as Growth Bio Hormone Replacement begins and continues. Since Growth Hormone can lead to a reduced sensitivity to insulin, especially in individuals that are obese, patients ideally need to be observed to monitor levels of glucose tolerance. Patients that have a glucose intolerance or diabetes need to be closely monitored as Growth Hormone Therapy progresses.

Nutropin treatment for adults with adult-onset Growth Hormone Deficiency has been associated with an increased level of median fasting insulin among those that receive Nutropin 0.0125mg/kg/day from a level of 9.0 'U/mL initially to a level of 13.0 'U/mL after one year. One returns to baseline median after a three week period post-washout after Growth Hormone Therapy. Among placebo participants, no change was noted from the 8.0 'U/mL between the initial baseline and one year. The median after the post-washout period was 9.0 'U/mL. The difference between the treatment groups in the change from baseline to one year was significant (p&lt;0.0001). In the group of adults that suffered from childhood onset GHD, there was a change in the median fasting level of insulin in the 0.025 mg/kg/day Nutropin group from an initial level of 11.0 'U/mL at the initial baseline to a level of 20.0 'U/mL after one year. With the 0.0125 mg/kg/day Nutropin group the level increased from 8.5 'U/mL to a level of 11.0 'U/mL. The difference between these treatment groups was significant (p=0.0007).

In participants with adult-onset Growth Hormone deficiency, there was not a difference between treatment groups regarding change from baseline to year one in average HbA1c (p=0.08). Among participants with childhood-onset GHD, average HbA1c levels were increased in the 0.025 mg/kg/day Nutropin group from a level of 5.2% at the initial baseline to 5.5% after one year. In the 0.0125 mg/kg/day Nutropin group, levels of HbA1c did not change from 5.1% at baseline, nor did they change from 5.3% from the baseline of the placebo group. The difference between treatment groups was significant (p=0.009).

Patients that have a history of intracranial lesion need to be examined with frequency to monitor for the recurrence of progression of the lesion. In child patients, the clinical research literature has shown no relationship between recurrence of central nervous system tumors, development of extracranial tumors, and Growth Hormone Replacement Therapy. However, in adults it is not known if there is any relationship between the recurrence of CNS tumors and Growth Hormone Replacement Therapy.

Patients that experience failure of growth concurrent with CRI need to be tested periodically for evidence as to whether renal osteopystrophy is progressing. In children that are in an advanced stage of renal osteodystrophy, avascular necrosis or epiphysis of the head of the femoral bone may occur, and it is unclear whether these problems are affected in any way by Growth Hormone Therapy. Patients should undergo hip x-rays before starting Growth Hormone Therapy if they suffer from CRI. Parents and bioidentical hormone therapy doctorsneed to make sure the child does not develop a limp, and they need to ask the child if he or she is experiencing hip or knee pain as they undergo Saizen treatment.

Patients that suffer from endocrine disorders and those who are growing rapidly may experience slipped capital femoral epiphysis more often than the general population.

Scoliosis progression may also occur in those patients who are experiencing rapid growth. Since Growth Hormone boost the growth rate, those patients that have a history of scoliosis and are treated with Growth Hormone need to be monitored to check for further scoliosis progression. There is no evidence that Growth Hormone leads to an increased incidence of scoliosis. Those that have Turner syndrome and leave it untreated often develop abnormalities of the skeletal system such as scoliosis. Bioidentical hormones doctors must be very alert to the potential for these abnormalities because they may appear as the patient undergoes Saizen treatment.

Those patients that have Turner Syndrome need to be monitored carefully for otitis media and other disorders of the ear because this subset of patients has a greater risk of developing hearing or other ear disorders.

In a controlled, randomized trial, there was found to be a statistically significant increase in ear disorders (18% vs. 5%) and otitis media (43% vs. 26%) in patients receiving GHT when compared to those that were untreated controls. In addition to this, patients that are maligned with Turner syndrome need to be monitored very closely for disorders of the cardiovascular system such as hypertension, aortic aneurism, and stroke because there are higher incidences for these conditions as compared to the general population.

Intracranial hypertension (IH) with vomiting, nausea, visual changes, and/or papilledema occurs in a small minority of patients that are treated with Growth Hormone products. These symptoms usually appeared within the first two months of Growth Hormone therapy. In all of these cases that were reported, symptoms and signs of intracranial hypertension were resolved after Growth Hormone treatment was terminated or the Growth Hormone dosage was modified. It is recommended that patients undergo funduscopic examination at the beginning of treatment and then periodically throughout the regimen of Growth Hormone Therapy. Patients that suffer from Turner syndrome and CRI could possibly be at an elevated risk for IH.

As is true with any protein, systemic or local allergic reactions may occur. The patient and/or the parents of the patient need to be informed about how these reactions are a possibility and that immediate medical attention should be sought in the case of an adverse allergic reaction.

Lab Tests: Serum levels of parathyroid hormone (PTH), alkaline phosphotase, and inorganic phosphorus may elevate due to Saizen therapy.

Hypothyroidism, when left untreated, can hinder the medicinal ability of Saizen. Those patients that have Turner syndrome have a significantly increased chance of developing autoimmune thyroid disease. Levels of thyroid hormone in serum may drop during the course of Saizen treatment. For this reason, patients need to undergo tests of thyroid function periodically, and when it is indicated that levels are lower than normal, they should have thyroid hormone replacement therapy administered as well as Saizen.

Drug Interaction: Intensive glucocorticoid therapy will undermine the growth promotional effect of Saizen. Patients that have an ACTH deficiency should make sure that their dosage of glucocorticoid-replacement is adjusted to take into account this inhibitive effect on Human Growth Hormone.

The effect of Saizen upon patients that also have CRI and are concurrently undergoing glucocorticoid therapy has not bee clinically evaluated. glucocorticoid therapy could potentially undermine the growth promotional effect of Saizen. If a patient must be on both a glucocorticoid replacement therapy at the same time that they are on Saizen, the dose of the glucocorticoid should be adjusted carefully.

There has been no sufficient evidence released that discusses the interaction of Growth Hormone Replacement Therapies with other drugs that are used to treat CRI patients. There is a limited amount of released data that indicated that Growth Hormone Treatment increases the rate at which antipyrene is evacuated from the human body through the enzymatic actions of cytochrome P450 (CP450). The collected data suggests that the administration of Growth Hormone might alter the evacuation of the various compounds that CP450 liver enzymes are known to metabolize (including sex steroids, corticosteroids, cyclosporin, and anticonvulsants). It is recommended that patients who are undergoing Saizen therapy in combination with other drugs that are metabolized through the CP450 liver enzyme remain under careful monitoring.

Mutagenesis, carcinogenesis, and Fertility Impairment:

There have yet to be proper studies conducted regarding mutagenicity, carcinogenicity, and fertility in regard to Saizen therapy.

Pregnancy (Category C): There have been no released studies regarding Saizen and animal reproduction. It is unclear whether Saizen therapy can lead to fetal harm when injected into a pregnant woman, nor have there been studies as to whether Saizen has any effect upon a woman's reproductive capacity. It is only advisable to administer Saizen to a pregnant woman if it is clearly and absolutely needed.

Nursing Mothers: It is not cleat if Saizen is present in human milk. Since many drugs do pass into the mother's milk, one should exercise caution in administering Saizen to a mother who is nursing.

Parental information: Patients that are undergoing Growth Hormone Treatment and/or the parents of patients should be properly informed about the potential risks of HRT and benefits that are associated with Saizen treatment. If the HRT doctor feels that home therapy is a more desirable course of action than clinical therapy, the patient and/or caregiver should be given proper instruction on appropriate use of Saizen. Included in this information should be a review of the content within the Patient Information Insert. The information is included to assist in the effective and safe administration of Saizen. It should not be considered a full disclosure of all wanted and unwanted effects associated with Saizen.

If Saizen treatment is prescribed for home use, it is recommended that the patient acquire a container which is puncture-resistant in which to dispose of used needles and syringes. It is essential that patients and/or parents of patients be properly instructed of the vital importance of appropriate disposal. It is also important that they are cautioned upon why it is important that they do not reuse needles and syringes (for more information see the Patient Information Insert).

Side-Effects and Reactions...Is hormone replacement therapy safe?

As is true with all protein medicines and therapies, a small minority of patients might develop antibodies to the particular protein. Growth Hormone antibodies that have binding capacities lower than 2 mg/L have no effect on the efficacy of Saizen therapy. In the small number of cases where the binding capacity is greater than 2 mg/L, attenuation of growth has resulted. In clinical research studies, pediatric patients who were for the first time treated with Nutropin [somatropin for injection derived from Recombinant DNA] were screened for antibody production. In this survey, 0/125 CRI patients, 0/107 GHD patients, and 0/112 Turner syndrome patients developed antibodies that had binding capacities great than or equal to 2 mg/L over the course of 6 months. In a separate clinical research study of patients that were for the first time treated with Saizen [somatropin injection derived from recombinant DNA], none of the 38 Growth Hormone Deficient patients that were screened for the production of antibodies were found to have developed antibodies that had binding capacities that were greater than or equal to 2 mg/L over the course of 15 months.

Additionally, short-term renal function and immunologic studies were conducted with a group of patients that suffered from CRI. Researchers monitored the year of treatment for adverse effects that could be attributed to Growth Hormone antibodies. The scientists tested for BUN, creatinine evacuation, creatinine, rheumatoid factor, C4, C3, and Clq. There were no adverse effects found that were attributed to Growth Hormone antibodies.

In addition to making sure that a patient is properly following their Growth Hormone Treatment regimen, any patient who fails to properly respond to Growth Hormone therapy should be tested for Growth Hormone antibodies as well as for thyroid status.

There is some report of discomfort around the injection site with Saizen. This is most commonly reported in children that have switched to Saizen from a different Growth Hormone product. Reports of discomfort among adults taking Saizen are limited.

Growth HRT and cancer

Leukemia has occurred in a small minority of Growth Hormone Deficient patients that have been treated with GH. It is unclear if this higher risk of leukemia is associated with the pathology ofGrowth Hormone Deficiency, the Growth Hormone Therapy, or treatments for intracranial tumors such as radiation therapy. The current field of evidence does not allow experts to reach a conclusion as to whether leukemia can sometimes manifest due to Growth Hormone Therapy. The risk of leukemia to Turner syndrome, CRI, or GHD patients, if any risk exists, has yet to be established.

Other bio identical hormone replacement therapy side effectsthat have been displayed in patients treated with Growth Hormone Therapy include the following:

Metabolic: Transient, mild peripheral edema. In Growth Hormone Deficient adults, peripheral edema or edema was reported in 41% patients treated with Growth Hormone and 25% of patients treated with placebo.

Musculoskeletal: Carpal tunnel; arthralgias. In adults with Growth Hormone Deficiency, joint disorders such as arthralgias were reported in 27% of Growth Hormone treated patients and 15% of patients treated with placebo.

Skin: Rarely, increased development of pre-existing birthmarks and pigmentations occur; patients must be monitored closely for malignant transformation.

Endocrine: Gynecomastia is sometimes reported. Pancreatitis is very rarely reported.

Our physicians here at the Conscious Evolution Medical Institute are some of the most qualified in America. You can trust us to steer you through treatment safely and effectively. However, if any of these issues seem overly problematic, we also suggest that you research natural alternatives to HRT.

Overdose Complications

Acute overdose can cause hyperglycemia. Overdose over a long period of time can result in symptoms and signs of acromegaly and gigantism that are consistent with the known effects of having an excess of Growth Hormone (Read below for recommended and max dosage instruction).

Administration and Dosage

Saizen administration and dosage is dependent upon the needs and restrictions of the individual. Response to Growth Hormone Therapy among pediatric patients has a tendency to drop over time. However, among those pediatric patients who show no enhancement of growth rate, especially in the initial year of treatment it is often the case that there are compliance issues. Patients should be assessed intently to ensure that they are properly undergoing the regimen. Also, other potential causes of growth failure should be investigated, such as advanced bone age, undernutrition, and hypothyroidism.

Dosage

For patients with pediatric GHD it is recommended that a dosage of as much as 0.30 mg/kg/wk should be administered daily through subcutaneous injection.

For patients with adult GHD it is recommended that therapy begins at a level no greater than 0.006 milligrams/kilogram daily administered by subcutaneous injection. This dosage can be increased according to the needs of the patient upward to a top level of 0.025 milligrams/kilogram/day in patients that are under 35 years old. In patients that are older then 35, the maximum dosage should be 0.0125 milligrams/kilogram/day.

In order to minimize occurrence of side effects among overweight and older patients, it may be necessary to administer lower doses. Over the course of therapy, the dosage of Saizen is recommended to be decreased if excessive Insulin-Like Growth Factor-1 levels occur in the serum or if side effects begin to occur.

For patients suffering from Chronic Renal Insufficiency (CRI), a dosage of up to 0.35 mg/kg/wk is recommended and should be administered in equal portions daily by means of subcutaneous injection. Saizen therapy can continue up until the point of renal transplantation.

As a means to optimize therapy in those patients who require dialysis, the below injection schedule guidelines are recommended:

Patients undergoing Hemodialysis are recommended to receive administration nightly just before going to sleep, or at a minimum three to four hours after undergoing hemodialysis. This prevents the formation of hematomas from the heparin.

Patients undergoing CCPD are recommended to receive injection every morning after dialysis has been completed.

Patients undergoing CAPD are recommended to receive injection each night at the time of their exchange overnight.

Turner Syndrome

It is recommended that patients take a dose of up to 0.375 mg/kg/wk administered by subcutaneous injection in equal portions from three to seven times each week.

Administration

When removed from refrigeration, the solution of Saizen should be clear. Sometimes after refrigeration, you might notice that there are small and colorless particles in the solution. These are merely the proteins, and this is in no way unusual. Let the vial reach room temperature, then gently swirl. Do not shake! If the contents are cloudy, do not inject the solution!

Before inserting the needle, clean the septum of the vial of Saizen with an antiseptic solution or with rubbing alcohol so that the contents are not contaminated by microorganisms that could possibly be introduced through repeated insertions of the needle. It is vitally recommended that you administer Saizen using disposable, sterilized needles and syringes. The size of the syringe should be of a small volume so that the proper dose can be pulled from the vial with significant accuracy.

Storage and Stability

Saizen within the vial is stable for 28 days after the first use as long as it is refrigerated at 2-8 degrees Celsius (36-46 degrees Fahrenheit). Do not freeze the Saizen vial.

How Supplied

Saizen is packaged with 10 mg (about 30 IU) of sterile liquid somatropin in each vial.

Every carton holds 6 single vial containers holding one 2 mL vial of Saizen [somatropin injection derived from recombinant DNA] which contains 5 mg of somatropin per mL. NDC 50242-114-11

08 September 2012

SAIZEN HGH: Human Growth Hormone Product


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Saizen Human Growth Hormone Replacement Therapy

Saizen is one of a small, but growing number of legal HGH Hormone Replacement Therapy medications in the United States. Saizen is produced by the pharmaceutical manufacturer Merck Serono. Merck Serono is one of the largest drug manufacturers in the world, and is based in Geneva, Switzerland. This company is not to be confused with the domestic pharmaceutical company Merck & Company, and in North America, Merck Serono is known as EMD Serono. Saizen is an injectable form of Synthetic Human Growth Hormone.

The History of HGH

Originally, HGH Hormone Treatments were made from real Growth Hormone harvested from human tissue, but in the year 1981, medical researchers were able to figure out a way to synthetically produce Bio-Identical HGH in a laboratory. Before it was possible to manufacture Bio-Identical Human Growth Hormone, HGH treatments were far more costly than they are today, and as a result of this breakthrough, and others since, Human Growth Hormone Injectable Therapy has continued to become cheaper and more affordable to the average consumer.

Saizen Human Growth Hormone is Simple and Easy to Use

Saizen HGH follows in that legacy of making Growth Hormone cheaper and easier to use. The following are a number of products released by Serono in order to perform HGH Hormone Replacement Therapy:

Saizen HGH Therapy Administration Devices

Saizen Cool.Click HGH Treatment

The Saizen cool.click is a revolutionary means of delivering Human Growth Hormone. Although the HGH is still delivered subcutaneously via injection, the Saizen cool.click does not need a needle! The cool.click works by creating a small hole through which Saizen Human Growth Hormone is delivered. This tiny hole is produced using a spring mechanism. In the past, many people have been nervous about HGH Hormone Replacement because before this point, the only way to deliver HGH was directly through a potentially imposing needle. Many people just can't commit to any medical therapy which requires them to stick themselves with a needle every day.

Although the Saizen cool.click was the first needle-free means of delivering HGH Hormone Replacement Therapy, EMD Sorono has updated the design to increase ease of use, comfort, and accuracy, with an updated version known as the Saizen cool.click2.

EMD Serono lists the following features of the Saizen cool.click2:

Needle-less delivery This form of HGH Delivery vastly reduces needle anxiety.

Easy-to-read LCD monitor The monitor displays dosing information and can ensure that a patient delivers exactly enough Saizen HGH in order to properly treat his or her HGH Deficiency.

Thoughtful shape and design the Saizen cool.click2 is ergonomically configured in order to maximize ease of use.

Reduced noise the cool.click2 is much quieter than its previous design, allowing you to deliver HGH without bringing attention to yourself.

Reverse dosage dialing this mechanism allows the patient to adjust and readjust dosage at any point before administering HGH Hormone Replacement Therapy.

Alterable injection pressure This HGH Injection Tool lets you adjust the rate at which the spring mechanism pierces the skin, allowing you to minimize potential discomfort at the injection site.

Safer than needles Because of the way that the cool.click2 is designed, there is virtually no risk of accidentally pricking yourself. The spring mechanism only exposes itself at your command, and you don't have to cautiously prepare a needle for every injection.

Delivers doses in both milligrams and milliliters the cool.click2 can adapt to different measurement scales, allowing you to dose accurately in regard to both mass and volume.

HGH Therapy with Saizen Easypod

Like the Saizen cool.click, the Saizen easypod is another product produced by EMD Serono which is designed with comfort and ease of use particularly in mind. The easypod is a simple-to-use injection device which quickly and accurately delivers injections of Bio-Identical HGH.

The easypod is what is known as an easy injector. This means that the easypod is a means to deliver injections of HGH without the vigorous protocol of a standard needle injection. The Saizen easypod has the capability of quickly and automatically titrating the appropriate dose of HGH. Upon pressing the trigger button, the machine automatically provides an injection of Human Growth Hormone, minimizing the amount of potential contact the you will make with the needle.

The Saizen easypod exclusively uses cartridges known as Saizen click.easy in order to deliver the intended dosage. The click.easy device serves two primary purposes. First, the click.easy is a reconstitution device. The Saizen Human Growth Hormone is combined with a fully sanitized solution in order both to rehydrate anhydrous HGH and to convert the Human Growth Hormone into a deliverable form. Second, the click.easy is a delivery device.

The click.easy is designed and shaped in a way which allows the patient to use it in combination with the Saizen easypod in order to maximize safety and ease of delivery. The Saizen easypod can be used repeatedly in order to deliver HGH injections as long as it is properly maintained, and new needles are use for every injection. The easypod has a large monitor which allows patients of all ages to easily see and understand the instructions and options provided by the device.

The easypod also provides multiple means of decreasing discomfort associated with injection. The individual patient can adjust injection administration via four distinct settings: Needle Speed, Injection Speed, Injection Depth, Injection Time.

HGH Easypod Settings

Needle Speed This setting adjusts the speed at which the needle is injected through the skin. Using this method is much more precise than performing a manual injection.

Injection Speed This refers to the rate by which the Saizen Human Growth Hormone is delivered into the body. This setting is a substitute for manually adjusting the speed using the plunger of a needle.

Injection Depth With this setting, you can alter the depth at which the needle descends. Dependent upon the location of the injection, different depths may be required. In addition to this, some may find that deeper injections cause increased discomfort. Injection depth also depends upon which needle the patient uses.

Injection Time This prompt controls the amount of time that the needle remains in the skin after injection. Some patients find it more comfortable to increase the time between injection and needle removal.

The Saizen easypod also maintains a diary of past injections, allowing both you and your physician to have a record of your injection schedule. The goal of the Saizen easypod is to reduce the effort it takes to undergo safe and effective Human Growth Hormone Injections while also minimizing pain or discomfort which can result from the use of needles. The easypod even allows you to input expiration dates to ensure that you dispose of your reconstituted synthetic Human Growth Hormone as soon as it becomes expired and ineffective.

Saizen one.click HGH Injector

The Saizen one.click is another means of injecting Saizen Human Growth Hormone. Like the easypod, the one.click is another injection device which focuses on being easy to use. The one.click is a much simpler device than the easypod. This product is mechanical only and features no monitor or electrical equipment of any kind.

The one.click has an adjustable dial which controls how much Human Growth Hormone you inject in a single dose. In addition to this, you can also adjust the depth of the needle injection manually. One of the primary advantages of the Saizen one.click is that it is simple to store and easy to carry and conceal. Also, because the one.click is a completely mechanical device, it is cheaper than the easypod while also being easier to use than a standard injection.

The Saizen one.click automatically delivers the HGH injection with a single click, minimizing the time it takes to deliver the injection. The device itself also minimizes potential inappropriate contact with the needle as well. As with all forms of Recombinant Human Growth Hormone, the reconstituted solution should be stored at temperatures between 36 and 46 degrees Fahrenheit in order for the hormone to remain effective and useful.

Saizen click.easy

The Saizen click.easy is the simplest injection device that Merck-Serono provides. This product still has the capability of injecting HGH Hormone Replacement Therapy quicker and more simply than a standard injection, but lacks all of the bells and whistles associated with the other Saizen Delivery Devices. This product still minimizes needle exposure and also delivers a subcutaneous injection with a single click, however. This device is for patients who want a quick and easy way to inject HGH Therapy without the need or desire to make more precise adjustments with other more high-tech injection devices.

How is Saizen HGH Supplied?

Saizen is generally provided to the patient via two means:

HGH Direct Injection

For patients who are not interested in using the Saizen Delivery devices listed above, there is the option of simply delivering the Human Growth Hormone via needle and syringe. For patients who are interested in administering HGH in this way, Saizen is available in vials. Saizen vials are available in two different sizes. Both 5 milligram vials and 8.8 milligram vials are available. These vials contain lyophilized Bio-Synthetic Human Growth Hormone. HGH is highly sensitive in its normal form, and must be freeze-dried and hermetically sealed in order to survive periods of extended storage and transport. When the Saizen is ready to be used, the powdered HGH must be reconstituted with a diluent. The diluent is a sterilized, clear solution that does not interact with the HGH molecule and can deliver the medication into subcutaneous tissue.

HGH Cartridge Delivery

For patients who wish to use delivery devices such as those listed above, Merck-Serono provides Saizen HGH Cartridges which are designed especially to be used with Saizen Human Growth Hormone Administration Devices. Saizen cartridges contain both lyophilized Human Growth Hormone and the sterilized diluent, separated by a small barrier. When you are ready to use the Saizen HGH Cartridge in one of the devices listed above, you will insert the cartridge into the device and follow the instructions provided with the device in order to combine and reconstitute the solution. After the cartridge of Human Growth Hormone has been activated and given time to fully hydrate, the solution is ready for injection. There are a few different options for the Saizen Cartridge, and these options are dependent upon both the size and strength of your individual dose.

Saizen Questions

At what Temperature Should Saizen be Stored?

Like all forms of Bio-Identical Human Growth Hormone, Saizen must be properly stored in order to remain potent. Lyophilized Saizen which has not been combined with diluent can be safely stored at room temperature (between 59 and 86 degrees Fahrenheit). After reconstitution, Saizen should always be refrigerated, except when it is immediately going to be used for injection. Reconstituted Saizen HGH should be stored between temperatures of 36 and 46 degrees Fahrenheit.

Does Saizen Contain Preservatives?

Saizen does contain preservatives in order to maximize the length of time that HGH is stable and usable. The vial form of Saizen contains benzyl alcohol, and the cartridge form of Saizen contains metacresol.

How Often Should I Take Saizen Injections?

The frequency with which you administer HGH Hormone Injections is completely dependent upon your physician's advice. Generally, injections are delivered once daily, just before bed, but there are a number of other options available which will not have a negative effect on your therapy. Nightly injections are thought to have the most beneficial effect on sleep and the cortisol cycle. Some prefer to take their doses early in the morning, or before engaging in exercise. Injecting before exercise is believed by some to increase the effectiveness of exercise, reducing fatigue and feeling of exhaustion. Some physicians even recommend that certain patients take two small doses each day rather than one larger dose once per day. It all depends on your age, goals, and needs as a patient.

What Are Saizen's Side-Effects?

The majority of patients will suffer from no side effects, or only the most minor symptoms. The most common symptoms are injection site irritation and possible headaches. Adult patients may rarely experience increased blood sugar, joint pain, and swelling as a result of Saizen. If any of these symptoms occur, please talk to your doctor.

07 May 2013

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