Generic name: SOMATROPIN 8.8mg in 1mL;
Dosage form: injection
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Zorbtive® should be administered to patients with short bowel syndrome (SBS) at a dose of approximately 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily. Administration for more than 4 weeks has not been adequately studied.
Injections should be administered daily for 4 weeks. Changes to concomitant medications should be avoided. Patients and physicians should monitor for adverse events. Treat moderate fluid retention and arthralgias symptomatically or dose reduce by 50%. Discontinue Zorbtive® for up to 5 days for severe toxicities. Upon resolution of symptoms, resume at 50% of original dose. Permanently discontinue treatment if severe toxicity recurs or does not disappear within 5 days.
Injection sites should be rotated.
Safety and effectiveness in pediatric patients with short bowel syndrome have not been established.
Each vial of Zorbtive® 8.8 mg is reconstituted in 1 to 2 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). See Table 4 below for expected concentration after reconstitution. Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials. For patients sensitive to Benzyl Alcohol, see “WARNINGS”.
|1 mL||2 mL|
To reconstitute Zorbtive®, inject the diluent into the vial of Zorbtive® aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Zorbtive® solution should be clear immediately after reconstitution. DO NOT INJECT Zorbtive® if the reconstituted product is cloudy immediately after reconstitution or after refrigeration. The reconstituted Zorbtive® 8.8 mg can be refrigerated (2-8oC/36-46oF) for up to 14 days. Occasionally, after refrigeration, small colorless particles may be present in the Zorbtive® 8.8 mg solution. This is not unusual for proteins like Zorbtive®. Allow refrigerated solution to come to room temperature prior to administration. A standard insulin-type subcutaneous syringe is recommended for administration.
STABILITY AND STORAGE
Before Reconstitution: Vials of Zorbtive® and diluent should be stored at room temperature, (15-30°C/59-86°F). Expiration dates are stated on product labels.
After Reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol. The reconstituted solution should be stored under refrigeration (2-8oC/36-46oF) for up to 14 days. Avoid freezing reconstituted vials of Zorbtive®.