Drug Detail:Zorbtive (Somatropin [ soe-ma-troe-pin ])
Generic Name: SOMATROPIN 8.8mg in 1mL;
Dosage Form: injection
Drug Class: Growth hormones
Recommended Dosage
The recommended dosage of Zorbtive® in adults is 0.1 mg/kg subcutaneously once daily to a maximum daily dose of 8 mg for 4 weeks.
Dosage Titration for Fluid Retention and Arthralgia/Carpal Tunnel Syndrome [see Warnings and Precautions (5.6, 5.7)]
- For moderate toxicity, treat symptomatically with analgesics or reduce the dosage of Zorbtive® to 0.05 mg/kg (maximum total dose of 4 mg) subcutaneously once daily.
- For severe toxicity, discontinue Zorbtive® for up to 5 days. Upon resolution of symptoms, resume Zorbtive® at 0.05 mg/kg (maximum total dose of 4 mg) subcutaneously once daily. Permanently discontinue Zorbtive®, if severe toxicity recurs or does not disappear within 5 days.
Preparation Instructions
Zorbtive® is provided in a package that contains all items required to reconstitute and inject the drug [see How Supplied/Storage and Handling (16)]. Prepare Zorbtive® using the following steps.
- 1.
- Determine the volume needed for the prescribed dosage based on the patient's weight and recommended dosage. Patient weight should be rounded to the nearest kilogram when determining dose. Table 1 below provides the volume of diluent to be added for the reconstitution and concentration of the reconstituted solution for Zorbtive® vial 8.8 mg.
| Adult Patient Weight (kg) | Volume of diluent to be added for the reconstitution (mL) | Concentration of reconstituted solution (mg/mL) |
|---|---|---|
| More than 44 kg | 1 mL | 8.8 mg/mL |
| Less than or equal to 44 kg | 2 mL | 4.4 mg/mL |
- 2.
- Use appropriate aseptic technique when preparing and administering Zorbtive®.
- 3.
- Reconstitute the vial(s) of Zorbtive® with either 1 mL or 2 mL of Bacteriostatic Water for Injection, USP (containing Benzyl Alcohol) using a 3 mL syringe. Inject the appropriate amount of diluent into the vial of Zorbtive® aiming the liquid against the glass vial wall. For patients unable to receive Benzyl Alcohol, Zorbtive® may be reconstituted with Sterile Water for Injection, USP [see Warnings and Precautions (5.12)].
- 4.
- Gently swirl the vial in circles until the contents are dissolved completely. DO NOT SHAKE.
- 5.
- Visually inspect the reconstituted solution. The final reconstituted solution should be clear and colorless. Discard the vial if the solution is cloudy or contains particulate matter.
Administration Instructions
- Withdraw the required volume of the reconstituted solution using a 1 mL syringe with a 29-gauge needle.
- Inject the full contents of the syringe subcutaneously at a 90° angle into the top side of the thigh, the areas around the belly button, the back of the upper arms, and the buttocks or hips.
- Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard.
Storage of Diluted Solution
Once reconstituted with Bacteriostatic Water for Injection, USP (containing Benzyl Alcohol), Zorbtive® should be stored under refrigeration (2 to 8°C/36 to 46°F) and for no more than 14 days. Do not freeze. If Zorbtive® is reconstituted with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused solution should be discarded.
