"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Read this Patient Information before you start taking Zavesca and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is Zavesca?
It is not known if Zavesca is safe and effective in children under 18 years of age.
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.
- Take Zavesca at the same time each day.
- If you miss a dose of ZAVESCA, skip that dose. Take the next ZAVESCA capsule at the usual time.
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.
How should I store Zavesca?
- Store Zavesca at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Zavesca and all medicines out of the reach of children.
General information about the safe and effective use of Zavesca.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Zavesca for a condition for which it was not prescribed. Do not give Zavesca to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zavesca that is written for health professionals.
For more information about Zavesca call 1-866-228-3546 or go to www.Zavesca.com.
What are the ingredients in Zavesca?
Active ingredient: miglustat
Inactive ingredients: sodium starch glycollate, povidone (K30), and magnesium stearate.
The capsule shell contains: gelatin and titanium dioxide; the edible printing ink contains black iron oxide and shellac.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 2/21/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zavesca Information
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