HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 INDICATIONS AND USAGESOMAVERT 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-1 (IGF-1) levels. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSFor injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg lyophilized powder in a single-dose vial for reconstitution supplied with a prefilled syringe containing 1 mL of diluent (Sterile Water for Injection, USP). (3) CONTRAINDICATIONSNone. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONSFemales 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. Revised: 7/2023 |
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 INDICATIONS AND USAGESOMAVERT 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-1 (IGF-1) levels. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSFor injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg lyophilized powder in a single-dose vial for reconstitution supplied with a prefilled syringe containing 1 mL of diluent (Sterile Water for Injection, USP). (3) CONTRAINDICATIONSNone. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONSFemales 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. Revised: 7/2023 |
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