Improvement in Overall
Signs & Symptoms
In the same 12-week study, SOMAVERT demonstrated clinically significant improvement in total score for signs and symptoms at each dose.4
Improvement in total score for signs and symptoms for all dose levels of SOMAVERT vs placebo at week 124
Total score for signs and symptoms
*For a difference in mean change from baseline versus placebo (Dunett's test)
- Total score for signs and symptoms was based on scores for 5 symptoms, each graded in severity from 0 (absent) to 8 (worst). Thus, the total possible score ranged from 0-40. The 5 symptoms graded were fatigue, perspiration, headache, arthralgia, and soft-tissue swelling. The mean change from baseline for each dose was calculated based on the change in total score at 12 weeks across all patients in that dosing arm. Mean baseline total score for signs and symptoms (among subjects) in all dose groups combined was 15.2.
- At 12 weeks, mean % change from baseline increased (worsened) 16% for placebo, and decreased (improved) 8% for 10mg, 20% for 15 mg, and 33% for 20 mg
In a derived post hoc analysis of this study 91% of patients
(52/57) treated with SOMAVERT who achieved age-adjusted normalized IGF-I levels also experienced improvement in their total scores for signs and symptoms.4
The derived, post hoc value is a result of post hoc analysis of the primary and secondary 12-week data, meaning the "91% efficacy" statement is derived from a comparison of these data and not on value directly measured during the study. A post hoc analysis is any analysis not originally planned and specified in the statistical analysis plan (which is finalized prior to the start of the study).
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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.
