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ZAVESCA® (miglustat) reduces the harmful buildup of glycosphingolipids

In people with type 1 Gaucher disease, the body has an excess of fatty substances called glycosphingolipids (gli-coh-sfing-goh-lip-ids), or GSLs. That's because the body does not have enough of a certain enzyme that helps break down the GSLs.

GSLs may then build up over time. ZAVESCA helps reduce the amount of GSLs the body makes.* This way, the enzymes you do have are able to break them down.

*Based on laboratory studies.

About ZAVESCA

People with type 1 Gaucher disease also may have lowered levels of hemoglobin (a substance in red blood cells) and platelets (blood-clotting cells) that may cause anemia (low red blood cell count).1

ZAVESCA reduces the harmful buildup of glycosphingolipids throughout the body to help treat some of the symptoms of mild to moderate type 1 Gaucher disease in adult patients.2

Clinical studies have shown that ZAVESCA provides important benefits for people with mild to moderate type 1 Gaucher disease, whether they have been treated before with enzyme replacement therapy (ERT) or they are being treated for the first time.2 Individual results may vary.

ZAVESCA2:

  • Reduced swelling of the liver
  • Reduced swelling of the spleen
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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.
  • 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
  • Gas
  • Nausea and vomiting
  • Headache, including migraine
  • Leg cramps
  • Dizziness
  • Weakness
  • Vision problems
  • Muscle cramps
  • Back pain
  • Constipation
  • Dry mouth
  • Heaviness in arms and legs
  • Memory loss
  • Unsteady walking
  • Loss of appetite
  • Indigestion
  • 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 and Patient Information.

cp-113989v2

1.ZAVESCA® (miglustat) full prescribing information. Actelion Pharmaceuticals US, Inc.

What is ZAVESCA?

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.

 

REF:

1.Zeller JL, Burke AE, Glass RM. JAMA patient page. Gaucher disease. JAMA. 2007;298:1358.
2.ZAVESCA® (miglustat) full prescribing information. Actelion Pharmaceuticals US, Inc.