Zorbtive
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Questions & Answers
Side Effects & Adverse Reactions
Benzyl Alcohol as a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. If sensitivity to the diluent occurs, Zorbtive® [somatropin (rDNA origin) for injection] may be reconstituted with Sterile Water for Injection, USP. When Zorbtive® is reconstituted in this manner, the reconstituted solution should be used immediately and any unused portion should be discarded.
See “CONTRAINDICATIONS” for information regarding increased mortality in growth hormone-treated patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients developing acute critical illnesses should be weighed against the potential risk.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Zorbtive® [somatropin (rDNA origin) for injection] is indicated for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support. Zorbtive® therapy should be used in conjunction with optimal management of Short Bowel Syndrome.
Specialized nutritional support may consist of a high carbohydrate, low-fat diet, adjusted for individual patient requirements and preferences. Nutritional supplements may be added according to the discretion of the treating physician. Optimal management of Short Bowel Syndrome may include dietary adjustments, enteral feedings, parenteral nutrition, fluid and micronutrient supplements, as needed.
History
There is currently no drug history available for this drug.
Other Information
Zorbtive® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Zorbtive® 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 GH. Zorbtive® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Zorbtive® is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
Zorbtive® is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.
Zorbtive® is available in 8.8 mg vials for multi-dose administration. Each 8.8 mg vial contains 8.8 mg somatropin, 60.19 mg sucrose and 2.05 mg phosphoric acid. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.
Sources
Zorbtive Manufacturers
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Emd Serono, Inc.
![Zorbtive (Somatropin (Rdna Origin)) Kit [Emd Serono, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zorbtive | Emd Serono, Inc.
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”.
Table 4: Expected Concentration After Reconstitution (mg/mL) 1 mL 2 mL 8.8 mg 8.8 4.4To 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®.
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