Pegvisomant

What it is used for

SOMAVERT is 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.

Side effects, and when to stop

Clinically significant adverse reactions that appear in other section of the labeling include:

• Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus
• Liver Toxicity
• Cross-Reactivity with GH Assays
• Lipohypertrophy
• Systemic Hypersensitivity

Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies. One patient was rechallenged with SOMAVERT, and the recurrence of elevated transaminase levels suggested a probable causal relationship between administration of the drug and the elevation in liver enzymes. A liver biopsy performed on the second patient was consistent with chronic hepatitis of unknown etiology. In both patients, the transaminase elevations normalized after discontinuation of the drug.

Elevations in ALT and AST levels were not associated with increased levels of TBIL and ALP, with the exception of two patients with minimal associated increases in ALP levels (i.e., less than 3 times ULN). The transaminase elevations did not appear to be related to the dose of SOMAVERT administered, generally occurred within 4 to 12 weeks of initiation of therapy, and were not associated with any identifiable biochemical, phenotypic, or genetic predictors.

Who should not take it

None.

Storing it

Storage

Prior to reconstitution:

• The One Day Package of SOMAVERT should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).
• For the 30-Day Package, remove the three intermediate cartons containing the SOMAVERT vials and store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• For convenience, the One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vial(s), may be stored at room temperature up to 25°C (77°F) for a single period of up to 30 days.
  • o In the space provided on the carton, record the date when the carton was removed from the refrigerator and the discard date (30 days after removal from the refrigerator).
  • o Once the carton has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 30 days at room temperature, the vial(s) should be discarded.

Discard the SOMAVERT vial(s) after the expiration date printed on the carton or the discard date, whichever is sooner.

The prefilled syringe(s) may be stored at a temperature up to 30°C (86°F) until the expiration date printed on the carton, at which point they should be discarded.

Do not freeze.