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SOMAVERT® WITH PREFILLED DILUENT SYRINGE Highlights (pegvisomant with PREFILLED DILUENT SYRINGE)

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

Dosage and Administration (2.3, 2.4)8/2021

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

  • Administer a 40 mg loading dose subcutaneously under physician supervision. (2.1)
  • After proper injection instruction, on day after loading dose, patients or caregivers begin daily subcutaneous injections of 10 mg. (2.1)
  • Adjust dosage in 5 mg increments or decrements until serum IGF-I concentrations are maintained within age-adjusted normal range. Do not adjust dosage based on growth hormone (GH) levels or signs or symptoms of acromegaly. (2.1)
  • Dosage range is 10 mg to 30 mg once daily. (2.1)
  • Perform liver tests prior to first dosage and if greater than 3 times upper limit of normal should work-up prior to SOMAVERT administration. (2.2)
  • Follow reconstitution and injection procedures. (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

For 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)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Hypoglycemia: Monitor blood glucose in patients with diabetes mellitus and reduce anti-diabetic drug therapy as necessary. (5.1)
  • Liver Toxicity: Should have more frequent liver tests and/or discontinue SOMAVERT. (5.2)
  • Systemic Hypersensitivity: Monitor closely when re-initiating SOMAVERT in patients with systemic hypersensitivity. (5.5)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

  • Insulin and/or Oral hypoglycemic Agents: Patients with acromegaly and with diabetes mellitus may require careful monitoring and dose reductions of insulin and/or oral hypoglycemic agents. (5.2, 7.1)
  • Opioids: Patients on opioids may need higher SOMAVERT doses to achieve appropriate IGF-I suppression. (7.2)

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.

Revised: 8/2021

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