HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SOMAVERT safely and effectively. See full prescribing information for SOMAVERT.
SOMAVERT (pegvisomant) for injection, for subcutaneous use
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
For injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg lyophilized powder in single-dose vial for reconstitution with supplied 2.25 mL syringe containing 1 mL of diluent (Sterile Water for Injection) and a separate 27 gauge ½ inch safety needle. (3)
WARNINGS AND PRECAUTIONS
Most common reported adverse reactions (> 6%) are infection, pain, nausea, diarrhea, abnormal liver tests, flu syndrome, injection site reaction. (6)
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.
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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