Somavert Side Effects

Generic Name: pegvisomant

Please note - some side effects for Somavert may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Somavert - for the Consumer

Somavert

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Somavert:

Diarrhea; dizziness; nausea; pain; pain, redness, or itching at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; flu-like symptoms (eg, chills, fever, muscle aches, weakness); severe stomach pain; swelling of the legs and feet; thickening of the skin or lumps at the injection site; unusual weight gain; yellowing of the skin or eyes.

Somavert Side Effects - for the Professional

Somavert

Laboratory Changes

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.

General

Nine acromegalic patients (9.6%) withdrew from pre-marketing clinical studies because of adverse events, including two patients with marked transaminase elevations, 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.

Immunogenicity

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 anti-pegvisomant antibodies is commercially available for patients receiving Somavert.

Post-Marketing Experience

Lipohypertrophy has been reported in <5% of patients following pegvisomant administration.

Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in <2% of patients in the post-marketing experience. These reports were not associated with an increase in bilirubin, and there were no clinical consequences for these patients. Transaminase elevations normalized with time, most often after suspending treatment (Somavert should be used in accordance with the information presented in Table 4 with respect to liver test abnormalities).

Side Effects by Body System

Hepatic

During premarketing clinical studies two patients (0.8%) had elevations of serum concentrations of alanine aminotransferase and aspartate aminotransferase greater than 10 times the upper limit of normal. In both patients, the transaminase elevations normalized after discontinuation of the drug. In other studies, up to 12% of patients experienced abnormal liver function tests.

Hepatic side effects have included abnormal liver function tests (elevations of serum concentrations of alanine aminotransferase and aspartate aminotransferase) in up to 12% of patients treated.

Immunologic

Immunologic side effects have included the development of low titer non-neutralizing antigrowth hormone antibodies.

General

General side effects have included infection (23 to 33%), pain (8 to 23%), flu syndrome (12 to 21%), and accidental injury (8 to 18%).

Musculoskeletal

Musculoskeletal side effects have included back pain (8%) and chest pain (4%).

Respiratory

Respiratory side effects have included sinusitis (8%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4%) and nausea (8%).

Nervous system

Nervous system side effects have included headache (26%), dizziness (8%) and paresthesias (7%).

Cardiovascular

Cardiovascular side effects have included hypertension (8%) and peripheral edema (8%).

Local

Local side effects have included injection site reactions (11%).

Metabolic

Metabolic side effects have included hypercholesterolemia (14%). Lipohypertrophy has been reported in lass than 5% of patients following pegvisomant administration.

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