Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Saizen® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene. Saizen®, with the correct three-dimensional configuration, is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
Saizen® is a highly purified preparation. Biological potency is determined by measuring the increase in body weight induced in hypophysectomized rats.
Saizen® is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.
Saizen® is available in 1.33 mg vials. The quantitative composition per vial is:1.33mg (approximately 4 IU) vial:
The diluent is Bacteriostatic Water for Injection, USP containing 0.9% Benzyl Alcohol added as an antimicrobial preservative.
Saizen [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology.
Saizen has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone.
Growth hormone is used clinically to treat childrens growth disorders and adult growth hormone deficiency. In recent years, replacement therapies with human growth hormones (HGH) have become popular in the battle against aging and weight management. Reported effects include decreased body fat, increased muscle mass, increased bone density, increased energy levels, improved skin tone and texture, increased sexual function and improved immune system function.
At this time HGH is still considered a very complex hormone and many of its functions are still unknown.
Saizen® [somatropin (rDNA origin) for injection] is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Saizen® [somatropin (rDNA origin) for injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.
Pediatric Growth Hormone Deficiency (GHD)
Saizen® [somatropin (rDNA origin) for injection] dosage and schedule of administration should be individualized for each patient. For the treatment of growth hormone inadequacy in children, a dosage of 0.06 mg/kg (approximately 0.18 IU/kg) administered 3 times per week by subcutaneous or intramuscular injection is recommended.
Treatment with Saizen® of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused. Patients who fail to respond adequately while on Saizen® therapy should be evaluated to determine the cause of unresponsiveness.
Adult Growth Hormone Deficiency (GHD)
Based on the weight-based dosing utilized in the original pivotal study described herein, the recommended dosage at the start of therapy is not more than 0.005 mg/kg given as a daily subcutaneous injection. The dosage may be increased to not more than 0.01 mg/kg/day after 4 weeks according to individual patient requirements. Clinical response, side effects, and determination of age-and gender-adjusted serum IGF-I levels may be used as guidance in dose titration.
Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-I concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-I levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.
To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Saizen® be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.
After determining the appropriate patient dose, reconstitute each vial of Saizen®as follows: 5 mg vial with 1-3 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved); 8.8 mg vial with 2-3 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved). For use in patients sensitive to the diluent, see “WARNINGS.”
To reconstitute Saizen®, inject the diluent into the vial of Saizen® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Because Saizen® growth hormone is a protein, shaking can result in a cloudy solution. The Saizen® solution should be clear immediately after reconstitution. DO NOT INJECT Saizen® if the reconstituted product is cloudy immediately after reconstitution or refrigeration. Occasionally, after refrigeration, small colorless particles may be present in the Saizen® solution. This is not unusual for proteins like Saizen®.
STABILITY AND STORAGE
Before Reconstitution - Saizen® [somatropin (rDNA origin) for injection] should be stored at room temperature (15o-30oC/59o-86oF). Expiration dates are stated on the labels.
After Reconstitution - Saizen® 1.33 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (2°-8°C/36°-46°F) for up to 14 days.
Avoid freezing reconstituted vials or cartridges of Saizen®.
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