Pediatric Patients

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.

Adult Patients

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. The recommended weekly dosage is 0.18 mg/kg of body weight. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily. The subcutaneous route of administration is preferable; intramuscular injection is also acceptable.

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, 0.15-0.3 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.

Drug Preparation Instructions-Vials

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). Approximately 10% mechanical loss can be associated with reconstitution and multidose administration. 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®.

Drug Preparation Instructions-click.easy® cartridges

For drug preparation instructions for Saizen® click.easy® cartridges, please refer to the instructions for use provided with the click.easy® reconstitution device.

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® 5 mg and 8.8 mg vials reconstituted with 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.

Saizen® click.easy® cartridges reconstituted with the diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection should be stored under refrigeration (2°-8°C/36°-46°F) for up to 21 days.

Avoid freezing reconstituted vials or cartridges of Saizen®.

Saizen can be administered using (1) a standard sterile, disposable syringe and needle, (2) a compatible Saizen® needle-free injection device or (3) compatible Saizen® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.

Saizen® [somatropin (rDNA origin) for injection] is a sterile, non-pyrogenic, white, lyophilized powder supplied in packages containing:

1 vial of 5 mg Saizen® and 1 vial of 10 mL Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2

1 vial of 8.8 mg Saizen® and 1 vial of 10 mL Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1

1 click.easy® cartridge of 4 mg (1.5 mg/mL) Saizen® and 2.66 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection NDC 44087-0015-1

5 click.easy® cartridges of 4 mg (1.5 mg/mL) Saizen® and 2.66 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection NDC 44087-0015-5

1 click.easy® cartridge of 8.8 mg (5.83 mg/mL) Saizen® and 1.51 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection NDC 44087-1080-1

5 click.easy® cartridges of 8.8mg (5.83 mg/mL) Saizen® and 1.51 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection NDC 44087-1080-2

1 click.easy® cartridge of 8.8 mg (8 mg/mL) Saizen® and 1.10 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for Injection NDC 44087-2080-1

5 click.easy® cartridges of 8.8 mg (8 mg/mL) Saizen® and 1.10 mL diluent containing 0.3% (w/v) metacresol in Sterile Water for injection NDC 44087-2080-5

October 2007. Manufactured for: EMD Serono, Inc., Rockland, MA 02370 USA. FDA rev date: 10/31/2007

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