Making the most of ZAVESCA

ZAVESCA can provide benefits to people with type 1 Gaucher disease. Still, keep in mind that ZAVESCA may take some time to work in ways you can notice.

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Other considerations while taking ZAVESCA

To make the most of ZAVESCA therapy, you and your doctor may want to consider making some changes to your diet.

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Managing your diet can make a difference

In people with type 1 Gaucher disease, the body has an excess of fatty substances called glycosphingolipids (gli-coh-sfing-goh-lip-ids).1 These fatty substances are harmful when they build up in cells.1 ZAVESCA® (miglustat) works by limiting the body's production of these fatty substances.2

Just as it limits overproduction of these fatty substances, ZAVESCA may also limit how the body digests carbohydrates.2,3 Carbohydrates are found in grains, bread, rice, and flour. Simple sugars, found in things like soda, cookies, or desserts, are also carbohydrates. ZAVESCA may affect how long carbohydrates stay in the intestines, so carbohydrates may be digested more slowly than normal and can cause diarrhea and gas.2,4

Diarrhea is common with ZAVESCA and sometimes can be serious. Diarrhea appears to be the result of the effect of ZAVESCA on the body's digestion of carbohydrates.

While many people who take ZAVESCA may get gas, loose stools, or diarrhea, diarrhea decreased over time with continued ZAVESCA treatment, and may respond to individualized diet modification (e.g., reduction of sucrose, lactose, and other carbohydrate intake), to taking ZAVESCA between meals, and/or to anti-diarrheal medications, most commonly loperamide. Patients may be instructed to avoid high-carbohydrate foods during treatment with ZAVESCA if they present with diarrhea.2

Taking the simple step of reducing carbohydrates in the diet may help manage these side effects.

Talk to your doctor or a dietitian to see what may work best. Make certain to follow the doctor's directions about how to take ZAVESCA.

Other considerations

  • Eating small healthy snacks between meals, especially if weight loss is a concern.

  • Taking ZAVESCA® (miglustat) at the same time each day—for instance, if your prescription is for ZAVESCA 3 times a day, then take it when you first wake up, in the early afternoon, and before going to bed (or as close to 8-hour intervals as possible).

  • Taking ZAVESCA with or without food. Some people experience fewer side effects when taking ZAVESCA without food, while others see the opposite effect. Discuss with your doctor what works best for you.

  • It's important to remember that different people react to ZAVESCA in different ways. After being on ZAVESCA for a month, you may be able to slowly bring certain foods back into your diet as your body adjusts to therapy with ZAVESCA. Work with your doctor to talk about when the time might be right for you.

Talk to your doctor about your diet or about taking an anti-diarrheal medication if diarrhea is a problem for you.2

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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.Cox T, Lachmann R, Hollak C, et al. Novel oral treatment of Gaucher's disease with N-butyldeoxynojirimycin (OGT 918) to decrease substrate biosynthesis. Lancet. 2000;355:1481-1485.
2.ZAVESCA® (miglustat) full prescribing information. Actelion Pharmaceuticals US, Inc.
3.Andersson U, Butters TD, Dwek RA, Platt FM. N-butyldeoxygalactonojirimycin: a more selective inhibitor of glycosphingolipid biosynthesis than N-butyldeoxynojirimycin, in vitro and in vivo. Biochem Pharmacol. 2000; 59:821-829.
4.Belmatoug N, Burlina A, Giraldo P, et al. Gastrointestinal disturbances and their management in miglustat-treated patients. J Inherit Metab Dis. 2011;34:991-1001.