HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GENOTROPIN safely and effectively. See full prescribing information for GENOTROPIN
GENOTROPIN® (somatropin) for injection, for subcutaneous use
Initial U.S. Approval: 1987
INDICATIONS AND USAGE
GENOTROPIN is a recombinant human growth hormone indicated for:
DOSAGE AND ADMINISTRATION
GENOTROPIN should be administered subcutaneously (2)
DOSAGE FORMS AND STRENGTHS
GENOTROPIN lyophilized powder in a two-chamber color-coded cartridge (3):
GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative):
WARNINGS AND PRECAUTIONS
Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.3).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (7.1, 7.2).
See 17 for PATIENT COUNSELING INFORMATION.
No Current Announcements.
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