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ZAVESCA®
[zah-VEHS-kah]
(miglustat) Capsules

Read the Patient information that comes with ZAVESCA® (miglustat) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment.

What is ZAVESCA® (miglustat) ?

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

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

Who should not take ZAVESCA® (miglustat) ?

Do not take ZAVESCA® (miglustat) if you:

• are allergic to any of the ingredients in ZAVESCA (miglustat) . See the end of this leaflet for a complete list of ingredients.
• are pregnant or may become pregnant while taking Zavesca (miglustat)

What should I tell my doctor before taking ZAVESCA® (miglustat) ?

Before you take ZAVESCA (miglustat) tell your doctor if you:

• have kidney problems
• are pregnant or plan to become pregnant. ZAVESCA® (miglustat) may harm your baby. You should use effective birth control while taking ZAVESCA® (miglustat) . ZAVESCA® (miglustat) may also harm a man's sperm. All men
• should use effective birth control during treatment with ZAVESCA® (miglustat) and for 3 months after stopping ZAVESCA® (miglustat) . Do not use ZAVESCA® (miglustat) if you plan to become pregnant, or if your partner can become pregnant. See "Who should not take ZAVESCA (miglustat) ?"
• are breastfeeding. It is not known if ZAVESCA® (miglustat) passes into your milk and if it can harm your baby. You and your doctor should decide if you will breastfeed or take ZAVESCA® (miglustat) . You should not do both.
• have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect ZAVESCA® (miglustat) . ZAVESCA® (miglustat) may affect other medicines.

Know the medicines you take. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.

How should I take ZAVESCA® (miglustat) ?

• Take ZAVESCA® (miglustat) exactly as your doctor has prescribed. Check with your doctor or your pharmacist if you are not sure.
• Take ZAVESCA® (miglustat) at the same time or times each day. Your doctor will prescribe the dose that is right for you.
• Swallow ZAVESCA® (miglustat) capsules whole with water. ZAVESCA® (miglustat) may be taken with or without food.
• If you miss a dose of ZAVESCA® (miglustat) , skip that dose. Take the next ZAVESCA® (miglustat) capsule at the usual time.
• If you take too much ZAVESCA® (miglustat) or overdose, call your doctor or local poison control center right away.

What should I avoid while taking ZAVESCA® (miglustat) ?

Do not become pregnant while taking ZAVESCA® (miglustat) . See "What should I tell my doctor before taking ZAVESCA (miglustat) ?"

What are the possible side effects of ZAVESCA® (miglustat) ?

ZAVESCA® (miglustat) 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® (miglustat) is needed if you develop new or worse hand tremors. Call your doctor if you get new hand tremors while taking ZAVESCA® (miglustat) or if 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® (miglustat) and during treatment with ZAVESCA (miglustat) .
• 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 lose weight when you start treatment with ZAVESCA® (miglustat) .
• Low Platelet Count. Your doctor may do blood tests to monitor your blood platelet count.

The most common side effects of ZAVESCA® (miglustat) are:

Tell 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® (miglustat) . For more information, ask your doctor or your pharmacist.

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

How do I store ZAVESCA® (miglustat) ?

• Store ZAVESCA® (miglustat) between 68°F to 77°F (20°C to 25°C)

Keep ZAVESCA® (miglustat) and all medicines out of the reach of children.

General information about ZAVESCA® (miglustat)

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use ZAVESCA® (miglustat) for a condition for which it was not prescribed. Do not give ZAVESCA® (miglustat) to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about ZAVESCA® (miglustat) . If you would like more information, talk with your doctor. You can ask you doctor or pharmacist for information about ZAVESCA® (miglustat) that is written for health professionals. For more information about ZAVESCA® (miglustat) call 1-866-228-3546 or go to www.ZAVESCA (miglustat) .com.

What are the ingredients in ZAVESCA®?

Active ingredient: miglustat

Inactive ingredients: sodium starch glycollate, povidone (K30) and magnesium stearate in the capsule; the capsule shell contains gelatin and titanium dioxide; the edible printing ink contains, black iron oxide and shellac.

What is type 1 Gaucher disease?

Type 1 Gaucher disease is an inherited disease that you get from both your parents. People with type 1 Gaucher disease are missing an enzyme that breaks down a chemical in the body called glucosylceramide. Too much glycosylceramide causes liver and spleen enlargement, changes in the blood, and bone disease. ZAVESCA® (miglustat) may stop glucosylceramide from forming.

What is type 1 Gaucher disease?

Type 1 Gaucher disease is an inherited disease that you get from both your parents. People with type 1 Gaucher disease are missing an enzyme that breaks down a chemical in the body called glucosy

Last reviewed on RxList: 1/11/2011
This monograph has been modified to include the generic and brand name in many instances.