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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Understanding food labels

One way to start managing your diet while on ZAVESCA® (miglustat) therapy

You have already learned that it may be important to make changes to your diet if you are experiencing diarrhea. Your doctor may recommend changes to your diet, such as minimizing the amount of food you eat containing high amounts of starch and sugars—specifically sucrose, maltose, and lactose—and to continue enjoying foods low in starch and carbohydrates. As described below, food labels can be your simple everyday guide to making good dietary choices.

Work with your doctor or a dietitian for help with choosing appropriate foods while you're on ZAVESCA therapy.

What the label says

This is an example of a food label.1

nutrition facts

Four sections of the label in particular are important to you while on therapy with ZAVESCA: serving size, carbohydrates, sugars, and ingredient list.

Nutrition Facts Label

Indicate nutrition facts

Serving size

The first place to start when you look at the Nutrition Facts label is the serving size and the number of servings in the package. Serving sizes are based in familiar units (such as cups or pieces), followed by an amount in metric units (such as milliliters or grams). In the fruit yogurt example, a serving size is one container.

nutrition facts

Carbohydrates and Sugars

Because it is recommended that you reduce certain sugars (disaccharides) while taking ZAVESCA, you should look at sugars listed under the carbohydrate section of the Nutrition Facts label. These include naturally occurring sugars (like those in fruit and milk) as well as those added to a food or drink.*

The example of the plain yogurt has 12g of sugars, while the fruit yogurt has 27g of sugars in one serving.

*You can check the ingredient list for sugars that are not natural and have been added.

nutrition facts

Ingredients list

Compare the ingredient lists for the two yogurts. Ingredients are listed in order of weight (from most to least). Make sure that added sugars are not listed as one of the first few ingredients. Other names for added sugars include corn syrup, high-fructose corn syrup, fruit juice concentrate, maltose, dextrose, sucrose, honey, and maple syrup.

You may notice that even though no added sugars or sweeteners are in the list of ingredients for the plain yogurt, the Nutrition Facts label shows 12g of sugars. This is because there are no added sugars in plain yogurt, only naturally occurring sugars (lactose in the milk).

Talk to your doctor first before making any changes to your diet.

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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.

 
1.US Food and Drug Administration. How to Understand and Use the Nutrition Facts Label.
http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm274593.htm. Accessed December 11, 2015.