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Accretropin

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Accretropin

INDICATIONS

Accretropin™ (somatropin) is indicated for:

DOSAGE AND ADMINISTRATION

The dose regimen for Accretropin™ [(somatropin) for injection] should be individualized for each patient. Therapy should not be continued if epiphyseal fusion has occurred. Response to growth hormone therapy tends to decrease with time. However, failure to increase growth rate, particularly during the first year of therapy, should prompt close assessment of compliance and evaluation of other causes of growth failure such as hypothyroidism, under-nutrition and advanced bone age.

Growth hormone deficiency - The recommended weekly dose is 0.18 mg/kg body weight to 0.3 mg/kg (0.90 IU/kg) body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.

Turner Syndrome - The recommended weekly dose is 0.36 mg/kg of body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.

Accretropin™ (somatropin injection) should not be injected intravenously.

Administration - the vial should be swirled with a GENTLE rotary motion. DO NOT SHAKE. The solution should be inspected for clarity. It should be clear. If the solution is cloudy or contains particles, the contents MUST NOT be injected.

Storage

Vials of Accretropin™ (somatropin injection) Injection should be stored in the refrigerator [2° to 8°C (36° to 46°F)]. Avoid freezing and shaking. Expiration dates are stated on the vial and carton labels. Do not use after expiration date. Once opened, Accretropin™ (somatropin injection) may be stored up to 14 days when refrigerated [2° to 8°C (36° to 46°F)]. Discard 14 days after first use. Protect from light.

HOW SUPPLIED

NDC Number Contents
60492-0162-1 A single vial carton containing one multidose vial and a package insert.

REFERENCES

Janssen YJ, Frolich M, Roelfsema F. The absorption profile and availability of a physiological subcutaneously administered dose of recombinant human growth hormone (GH) in adults with GH deficiency. Br J Clin Pharmacol 1999 Mar;47(3):273-8.

Zeisel HJ, Lutz A, von Petrykowski W. Immunogenicity of a mammalian cell-derived recombinant human growth hormone preparation during long-term treatment. Horm Res 1992;37 Suppl 2:47-55.

Manufactured by: Cangene Corporation, Winnipeg, Canada R3T 5Y3. March 2007. FDA Rev date: 1/23/2008

Last reviewed on RxList: 2/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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