What is ZAVESCA^® (miglustat)?

ZAVESCA is a prescription medicine taken by mouth for adults with mild to moderate type 1 Gaucher disease. ZAVESCA is used only in people who cannot be treated with enzyme replacement therapy.

It is not known if ZAVESCA is safe and effective in children under 18 years of age.

Who should not take ZAVESCA?

• Do not take ZAVESCA if you are allergic to any of its ingredients. The active ingredient is miglustat.
• Do not take ZAVESCA if you are pregnant or may become pregnant while taking ZAVESCA.

What should I tell my doctor before taking ZAVESCA?

Before you take ZAVESCA tell your doctor if you:

• Are pregnant or planning to become pregnant. ZAVESCA may harm your baby. You should use effective birth control while taking ZAVESCA.
  ZAVESCA may also harm a man's sperm. All men should use effective birth control during treatment with ZAVESCA and for 3 months after stopping ZAVESCA.
• Are breast-feeding. It is not known if ZAVESCA passes into your milk and if it can harm your baby. You should decide either to breast-feed or take ZAVESCA, but not both.
• Have kidney problems
• Have any other medical conditions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and other dietary supplements. Some medicines may affect ZAVESCA. ZAVESCA may affect other medicines.

How should I take ZAVESCA?

• Take ZAVESCA exactly as your doctor has prescribed. Check with your doctor or your pharmacist if you are not sure.

What are the possible side effects of ZAVESCA?

ZAVESCA may cause serious side effects including:

• Problems affecting your nerves (neurologic problems):

  New or worse hand tremors (shaky movements). Tremors may begin within the first month of starting treatment. Sometimes the tremors may go away between 1 to 3 months with continued treatment. Sometimes a lower dose or stopping ZAVESCA is needed to help the tremors go away. Call your doctor if you get hand tremors while taking ZAVESCA or the hand tremors you already have get worse.

  Numbness and tingling in your hands, arms, legs, or feet (peripheral neuropathy). Call your doctor right away if you get numbness or tingling in your arms or legs.

  Your doctor may test your nerves (neurological exam) before you start ZAVESCA and may repeat this procedure at a later time.

• Diarrhea. Your doctor may give you another medicine (anti-diarrheal) to treat diarrhea if it is a problem for you, and may recommend changes to your diet.
• Weight loss. You may also lose weight when you start treatment with ZAVESCA.
• Low Platelet Count. Your doctor may do blood tests to monitor your blood platelet count.

The most common side effects of ZAVESCA are:

Call your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects with ZAVESCA. For more information, ask your doctor or your pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA 1088.

Please see full Prescribing Information.