Pegvisomant Side Effects

Some side effects of pegvisomant may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pegvisomant: subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking pegvisomant: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using pegvisomant and call your doctor at once if you have a serious side effect such as:

• nausea, upper stomach pain, loss of appetite;

• swelling, rapid weight gain; or

• itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of pegvisomant may include:

• pain;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• fever, chills, body aches, flu symptoms;

• mild nausea, diarrhea;

• changes in the shape or location of body fat; or

• pain, swelling, burning, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pegvisomant: subcutaneous powder for injection

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 less than 5% of patients following pegvisomant administration.

Hypersensitivity

Hypersensitivity reactions have included postmarketing reports of systemic hypersensitivity reactions including anaphylactic reactions, laryngospasm, angioedema, and generalized skin reactions (rash, erythema, pruritus, and urticaria).

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