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Zavesca®

Brand Name: Zavesca®
Active Ingredient:   miglustat
Strength(s): 100 mg
Dosage Form(s):   Capsule
Company Name:    Galen Limited; Actelion Pharmaceuticals US Inc.
Availability:         Prescription only
*Dated Approved by FDA:   July 31, 2003
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Zavesca used for?  

Zavesca is used to treat adults with mild to moderate type I Gaucher disease. Zavesca is only used in patients who cannot be treated with enzyme replacement therapy. Zavesca has not been studied in children under 18 years of age. 

Type I Gaucher disease is an inherited disease that you get from both your parents. People with Type I Gaucher disease are missing an enzyme that breaks down a chemical in the body called glucosylceramide. Too much glucosylceramide causes liver and spleen enlargement, changes in the blood, and bone disease. Zavesca may stop glucosylceramide from forming.

Who should not take Zavesca?

Do not take Zavesca if you are allergic to any of its ingredients. The active ingredient is miglustat.

Special Warnings with Zavesca:

Do not get pregnant while taking Zavesca. Men and women should use effective birth control during treatment with Zavesca. Men should keep using effective birth control for 3 months after treatment with Zavesca stops.

General Precautions with Zavesca:

  • Zavesca can cause problems affecting your nerves (neurologic problems). It may cause hand tremors (shaky movements), or worsening of a hand tremor that you already have. 
  • Zavesca may also cause numbness and tingling in your hands, arms, legs, or feet (peripheral neuropathy).

What should I tell my doctor or health care provider?

Tell your doctor before taking Zavesca:

  • if you are pregnant or planning to become pregnant, or if your partner can become pregnant. Zavesca may harm your baby. Zavesca may also harm a man’s sperm. 
  • if you are breast-feeding. 
  • about all of your medical conditions. 
  • about all the medicines you take, including prescription and non-prescription medicines, vitamins, and other dietary supplements. Some medicines may affect Zavesca, and Zavesca may affect other medicines.

What are some possible side effects of Zavesca? (This is NOT a complete list of side effects reported with Zavesca. Your health care provider can discuss with you a more complete list of side effects.)  

Diarrhea is the most common side effect for people taking Zavesca. You may also lose weight when you start treatment with Zavesca. Some of the other side effects of Zavesca include: 

  • Gas 
  • Stomach pain 
  • Headache 
  • Dizziness 
  • Nausea 
  • Constipation 
  • Muscle cramps 
  • Weakness 
  • Cramps 
  • Do not feel like eating 
  • Vision problems 
  • Low platelet count

http://www.fda.gov/cder/foi/label/2003/21348_zavesca_lbl.pdf - Link to Zavesca labeling


For more detailed information about Reyataz, ask your health care provider or pharmacist.

Posted 10/27/03

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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