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|Miglustat

Miglustat

Miglustat is used for:

Treating mild to moderate type I Gaucher disease in patients for whom enzyme replacement therapy is not appropriate.

Miglustat is a glucosylceramide synthase inhibitor. It works by blocking an enzyme that reduces the formation of certain chemicals in the body (glucosylceramide-based glycosphingolipids). This helps to relieve some of the blood, liver, spleen, and other organ problems caused by this disease.

Do NOT use Miglustat if:

• you are allergic to any ingredient in Miglustat
• you are pregnant, could become pregnant, or if your partner could become pregnant
• you have severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Miglustat :

Some medical conditions may interact with Miglustat . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to soya lecithin, soybeans, or peanuts
• if you have kidney problems or a history of a sensation of numbness or tingling of the skin (peripheral neuropathy)

Some MEDICINES MAY INTERACT with Miglustat . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Imiglucerase because effectiveness may be decreased by Miglustat

This may not be a complete list of all interactions that may occur. Ask your health care provider if Miglustat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Miglustat :

Use Miglustat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Miglustat may be taken with or without food.
• Miglustat comes with an additional patient leaflet. Read it carefully and reread it each time you get Miglustat refilled.
• Take Miglustat regularly to receive the most benefit from it. Taking Miglustat at the same times each day will help you remember to take it.
• If you miss a dose of Miglustat , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Miglustat .

Important safety information:

• Miglustat may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Miglustat . Using Miglustat alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Miglustat contains soya lecithin. If you are allergic to soya lecithin, soybeans, or peanuts, check with your doctor before using Miglustat .
• Use effective methods of birth control while taking Miglustat . Because Miglustat may cause harm to sperm, men should also use effective birth control for 3 months after stopping Miglustat .
• Miglustat may cause diarrhea, especially when you begin taking it. Contact your doctor if the diarrhea becomes severe.
• Be sure to follow the diet program prescribed by your health care provider.
• Miglustat may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• LAB TESTS, including nervous system checks, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Miglustat with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Miglustat may cause harm to the fetus. Do not use Miglustat if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Avoid becoming pregnant while taking this medicine. It is unknown if Miglustat is excreted in breast milk. Do not breast-feed while taking Miglustat .

Possible side effects of Miglustat :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cramps; diarrhea; dizziness; dry mouth; unsteady gait; gas; headache; heavy limbs; indigestion; leg cramps; loss of appetite; menstrual disorders; migraine; nausea; stomach bloating, pain, or upset; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling sensation of the hands, arms, legs, or feet; memory loss; tremor or a worsening of existing tremor in your hands; unusual bleeding or bruising; vision problems.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include abnormal skin sensations; dizziness.

Store Miglustat at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Miglustat out of the reach of children and away from pets.

General information:

• If you have any questions about Miglustat , please talk with your doctor, pharmacist, or other health care provider.
• Miglustat is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Miglustat . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.