SOMAVERT Safety Information
SOMAVERT 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 Health Care Professionals
SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components.
The stopper on the vial of SOMAVERT contains latex.
Patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate
IGF-I level suppression compared with patients not receiving opioids.
Functional effects of increased GH are prevented by GH receptor blockade; therefore,
patients 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
- 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
- In clinical studies with SOMAVERT, 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.
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) include 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 daily maintenance dose should not exceed 30 mg/day.