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Somavert Side Effects

Generic Name: pegvisomant

Note: This document contains side effect information about pegvisomant. Some of the dosage forms listed on this page may not apply to the brand name Somavert.

For the Consumer

Applies to pegvisomant: subcutaneous powder for solution

Along with its needed effects, pegvisomant (the active ingredient contained in Somavert) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pegvisomant:

More common
  • Bleeding, blistering, burning, coldness, or discoloration of skin at site of injection
  • bloating or swelling of face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • chills
  • cough
  • dizziness
  • feeling of pressure
  • fever
  • headache
  • hives
  • hoarseness
  • infection, inflammation, itching, or lump at site of injection
  • nervousness
  • lower back or side pain
  • painful or difficult urination
  • pounding in the ears
  • rapid weight gain
  • slow or fast heartbeat
  • tingling of hands or feet
  • unusual weight gain or loss
Less common
  • Thickening of the skin
Incidence not known

Some side effects of pegvisomant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Accidental injury
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • general feeling of discomfort or illness
  • joint pain
  • muscle aches and pains
  • pain
  • pain or tenderness around eyes and cheekbones
  • runny or stuffy nose
  • shivering
  • shortness of breath or troubled breathing
  • sore throat
  • sweating
  • tightness of chest or wheezing
  • trouble sleeping

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.[Ref]

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.[Ref]

Immunologic

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

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%).[Ref]

Musculoskeletal

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

Respiratory

Respiratory side effects have included sinusitis (8%).[Ref]

Gastrointestinal

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

Nervous system

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

Cardiovascular

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

Local

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

Metabolic

Metabolic side effects have included hypercholesterolemia (14%). Lipohypertrophy has been reported in less than 5% of patients following pegvisomant (the active ingredient contained in Somavert) administration.[Ref]

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).

References

1. van der Lely AJ, Hutson RK, Trainer PJ, et al. "Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist." Lancet 358 (2001): 1754-9

2. "Product Information. Somavert (pegvisomant)." Pharmacia and Upjohn, Kalamazoo, MI.

3. Stewart PM "Pegvisomant: an advance in clinical efficacy in acromegaly." Eur J Endocrinol 148 Suppl 2 (2003): S027-32

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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