Home > Safety & Tolerability

Safety & Tolerability

Most adverse events were mild to moderate and did not appear to be dose dependent1

Within this section, you will learn about overall Adverse Events, and important safety information about Glycemic Parameters and Liver Testing

Number of patients (%) with acromegaly reporting adverse events in a 12-week placebo-controlled study with SOMAVERT1*

  • In the long-term pivotal trial, the most common adverse events (>10% and at frequencies greater than placebo) in 1 of 3 active treatment arms in a placebo-controlled study (n=112) included infection, pain, diarrhea, nausea, flu syndrome, abnormal liver function tests, and injection site reaction.

*Table includes only those events that were reported in at least 2 patients and at a higher incidence in patients treated with SOMAVERT than in patients treated with placebo.

**The 6 events coded as “infection” in the group treated with SOMAVERT 10mg were reported as cold symptoms (3), upper respiratory infection (1), blister (1), and ear infection (1). The 2 events in the placebo group were reported as cold symptoms (2) and chest infection (1).

Important Safety Information about Glycemic Parameters:

Patients with acromegaly and glucose intolerance or diabetes mellitus may require dose reductions of insulin and/or oral hypoglycemic agents because SOMAVERT has been shown to reduce serum glucose and insulin levels.

Monitor SOMAVERT patients for changes in glycemic parameters

Reductions in glycemic parameters after 6, 12 and 18 months of SOMAVERT in a long-term dose-titration trial1,3

  • Long-term dose-titration trial in 160 patients treated with SOMAVERT for an average of
    425 days. Dosing began at 10 mg/day and was titrated up or down as necessary in
    5-mg/day increments until the patient’s serum IGF-I levels were normal or until the
    maximum dose (in this study) of 40 mg/day was reached*
  • By binding to GH receptors, SOMAVERT blocks GH action thereby increasing glucose tolerance
  • SOMAVERT does not block glucogon or insulin secretion

*van der Lely AJ et al. Lancet. 2001;358:1754-1759.
**SOMAVERT. New York, NY: Pfizer Inc; 2012.

Important safety information regarding liver test monitoring

Monitor liver tests based on baseline values and changes during therapy according to the schedule in the full prescribing information. In clinical studies with SOMAVERT, ALT was >3X but <10X the upper limit of normal (ULN) in patients treated with SOMAVERT (1.2%) vs placebo (2.1%). ALT and AST elevations occurred within 4 to 12 weeks after the start of therapy and did not appear to be related to the dose. 2 patients (0.8%) experienced elevations of ALT and AST serum concentrations >10X the upper limit of normal (ULN). In both patients, the elevations normalized after discontinuation of the medicine. If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving SOMAVERT, please see Liver Tests section of full Prescribing Information.

SOMAVERT (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.

Important Safety Information for SOMAVERT

SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components.

Patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I suppression compared with patients not receiving opioids.

Functional effects of increased GH are prevented by GH receptor blockade; therefore, patients on SOMAVERT should be carefully observed for the clinical signs and symptoms of a GH-deficient state.

Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with SOMAVERT.

Important safety information regarding periodic tumor size monitoring
Tumors that secrete GH may expand and cause serious complications. All patients with GH-secreting tumors, including those receiving SOMAVERT, should be carefully monitored for changes in tumor volume. Overall, mean tumor size was unchanged during the course of treatment in clinical studies. Tumor volume change did not appear to be influenced by whether or not patients had previously received radiation therapy.

Important safety information regarding liver test monitoring
Monitor liver tests based on baseline values and changes during therapy according to the schedule in the full prescribing information. In clinical studies with SOMAVERT, ALT was >3X but <10X the upper limit of normal (ULN) in patients treated with SOMAVERT (1.2%) vs placebo (2.1%). ALT and AST elevations occurred within 4 to 12 weeks after the start of therapy and did not appear to be related to the dose. 2 patients (0.8%) experienced elevations of ALT and AST serum concentrations >10X the upper limit of normal (ULN). In both patients, the elevations normalized after discontinuation of the medicine. If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving SOMAVERT, please see Liver Tests section of full Prescribing Information.

In subjects with systemic hypersensitivity reactions, caution and close monitoring should be exercised when
re-initiating SOMAVERT therapy.

The most common adverse events (>10% and at frequencies greater than placebo) in 1 of the 3 active treatment arms in a 12-week placebo-controlled study (N=112) included infection, pain, diarrhea, nausea, flu syndrome, abnormal liver function tests, and injection-site reaction.

Injection sites should be rotated daily to help prevent lipohypertrophy.

The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.

Rx only


Please scroll for Important Safety Information and Indication

INDICATION

SOMAVERT® (pegvisomant for injection) 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-I (IGF-I) levels.

IMPORTANT SAFETY INFORMATION FOR SOMAVERT

SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components.

Patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I suppression compared with patients not receiving opioids.

Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with SOMAVERT.

Important safety information regarding liver test monitoring
Baseline serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP) levels should be obtained prior to initiating therapy with SOMAVERT. Monitor liver tests based on baseline values and changes during therapy according to the schedule in the full Prescribing Information.

Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in <2% of subjects among two open-label trials (with a total of 147 patients). These reports were not associated with an increase in bilirubin. Transaminase elevations normalized with time, most often after suspending treatment. If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving SOMAVERT, please see Liver Tests section of the full Prescribing Information.

In subjects with systemic hypersensitivity reactions, caution and close monitoring should be exercised when re-initiating SOMAVERT therapy.

The most common adverse events (>10% and at frequencies greater than placebo) in 1 of the 3 active treatment arms in a placebo-controlled study (N=112) included infection, pain, diarrhea, nausea, flu syndrome, abnormal liver function tests, and injection-site reaction.

Injection sites should be rotated daily to help prevent lipohypertrophy.

The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.

Rx only