Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two subjects (0.8%) exposed to SOMAVERT in pre-approval clinical studies (see PRECAUTIONS, Liver Tests [LTs]). General

Nine acromegalic patients (9.6%) withdrew from pre-marketing clinical studies because of adverse events, including two patients with marked transaminase elevations (see PRECAUTIONS, Liver Tests [LTs]),one patient with lipohypertrophy at the injection sites, and one patient with substantial weight gain. The majority of reported adverse events were of mild to moderate intensity and limited duration. Most adverse events did not appear to be dose dependent. Table 5 shows the incidence of treatment-emergent adverse events that were reported in at least two patients treated with SOMAVERT and at frequencies greater than placebo during the 12-week, placebo-controlled study.

In pre-marketing clinical studies, approximately 17% of the patients developed low titer, non-neutralizing anti-GH antibodies. Although the presence of these antibodies did not appear to impact the efficacy of SOMAVERT, the long-term clinical significance of these antibodies is not known. No assay for antipegvisomant antibodies is commercially available for patients receiving SOMAVERT.

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.

In clinical studies, patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I suppression compared with patients not receiving opioids. The mechanism of this interaction is not known.

Bookmark this page: