What is ZAVESCA® (miglustat)?
ZAVESCA is a prescription medicine used alone to treat 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.
IMPORTANT SAFETY INFORMATION
What should I tell my doctor before taking ZAVESCA?
Before you take ZAVESCA tell your doctor if you:
- have kidney problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if ZAVESCA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ZAVESCA passes into your breast milk. You and your doctor should decide if you will breastfeed or take ZAVESCA. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZAVESCA may affect how other medicines work.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take ZAVESCA?
- Take ZAVESCA exactly as your doctor has prescribed.
What are the possible side effects of ZAVESCA?
ZAVESCA may cause serious side effects including:
- Numbness, tingling, pain, or burning in your hands or feet (peripheral neuropathy). Call your doctor right away if you get numbness, tingling, pain, or burning in your hands or feet. Your doctor may test your nerves (neurological exam) before you start ZAVESCA and during treatment with ZAVESCA.
- New or worsening hand tremors (shaky movements). Tremors are common with ZAVESCA and may begin within the first month of starting treatment. Sometimes the tremors may go away between 1 to 3 months with continued treatment. Your doctor may lower your dose or stop ZAVESCA if you develop new or worsening hand tremors. Call your doctor right away if you get new hand tremors while taking ZAVESCA or if the hand tremors you already have get worse.
- Diarrhea is common with ZAVESCA and sometimes can be serious. Your doctor may prescribe another medicine (anti-diarrheal) to treat diarrhea if it is a problem for you and may recommend changes to your diet, such as avoiding foods high in carbohydrates. Talk with your doctor about your diet if you have diarrhea.
- Weight loss is common with ZAVESCA and sometimes can be serious. You may lose weight when you start treatment with ZAVESCA.
- Low platelet count is common with ZAVESCA and can be serious. Your doctor may do blood tests to monitor your blood platelet count.
The most common side effects of ZAVESCA are:
- Weight loss
- Stomach pain
- Nausea and vomiting
- Headache, including migraine
- Leg cramps
- Vision problems
- Muscle cramps
- Back pain
- Dry mouth
- Heaviness in arms and legs
- Memory loss
- Unsteady walking
- Loss of appetite
- Numbness, tingling, pain, or burning of your skin
- Stomach bloating
- Stomach pain not related to food
- Menstrual changes
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ZAVESCA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
|1.||ZAVESCA® (miglustat) full prescribing information. Actelion Pharmaceuticals US, Inc. February 2014.|