Drugs & Vitamins

Zavesca Active Ingredients: Miglustat Representative Names: Zavesca What are miglustat capsules? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with miglustat? What side effects may I notice from receiving miglustat? What should I watch for while taking miglustat? Where can I keep my medicine? What are miglustat capsules? (Back to top) MIGLUSTAT (Zavesca®) helps to prevent the reduction of a naturally occuring enzyme that is needed in your body to help with fat breakdown. It helps to keep normal blood levels of this enzyme, and it may help prevent your liver or spleen from getting big. Generic miglustat capsules are not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •dehydration •diarrhea or a condition that causes diarrhea •kidney disease •numbness, tingling or a burning sensation in your fingers, toes or other areas •tremors •an unusual reaction to miglustat, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Take miglustat capsules by mouth. Follow the directions on the prescription label. Take your doses at regular intervals at the same times each day. You may take miglustat with or without meals. Do not take your medicine more often than directed. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose of miglustat, just skip that dose. Wait until your next scheduled dose and take only that dose. Do not take double or extra doses. What drug(s) may interact with miglustat? (Back to top) •imiglucerase Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving miglustat? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •a numbness, tingling or burning feeling in your hands, feet or other parts of your body •in women, changes in your menstrual cycle (period) •problems with your eyes or vision •severe diarrhea •shakiness or tremors in your hands Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •cramps •dizziness •dry mouth •headache •loss in appetite •mild diarrhea •stomach pain or upset, nausea, vomiting •weakness •weight loss What should I watch for while taking miglustat? (Back to top) See your health care provider for regular checks on your progress. Your health care provider may need to monitor your kidney function while you are taking miglustat. This will usually be done by taking a blood sample. Diarrhea and tremors in your hands may be common side effects you will notice while taking miglustat. You may take other medicines to help control your diarrhea. Talk to your health care provider about which medications may be best for you. In females, this drug may cause harm to a developing baby if this drug is taken during pregnancy. It is important that you do not become pregnant while you are taking this drug. Use an effective form of birth control; talk to your health care provider regarding birth control options. Do not take this drug if you are already pregnant. Tell your health care provider if you think you may be pregnant. Men engaging in sexual intercourse should use a condom (or other form of effective birth control) while taking this drug to prevent pregnancy in their female partner, as drug-related sperm changes may lead to birth defects. Continue to use male condoms (or other forms of effective birth control) for 3 months after stopping the use of miglustat. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at controlled room temperature between 20 to 25 degrees C (68 to 77 degrees F). Keep away from extreme heat, humidity or moisture. Throw away any unused medication after the expiration date. Last Updated:09/04/2003 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.