Generic Name: miglustat (mih-GLOO-stat)
Brand Name: Zavesca
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 reducing the formation of certain substances in the body (glucosylceramide-based glycosphingolipids). This helps to relieve some of the blood, liver, spleen, and other organ problems caused by type I Gaucher disease.
Do NOT use miglustat if:
- you are allergic to any ingredient in miglustat
- you are pregnant or may become pregnantyour 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 have kidney problems
- if you have a history of a sensation of numbness or tingling of the skin (peripheral neuropathy), stomach or bowel problems (eg, inflammatory bowel disease), or hand tremors
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 its 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.
- An extra patient leaflet is available with miglustat. Talk to your pharmacist if you have questions about this information.
- Take miglustat by mouth with water, with or without food.
- Swallow miglustat whole. Do not break, crush, or chew before swallowing.
- Take miglustat on a regular schedule to get 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, 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 dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use miglustat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Women who may become pregnant should use effective birth control while they take miglustat. Check with your doctor if you have questions about effective birth control.
- Miglustat may be harmful to sperm. Men who use miglustat should use effective birth control while they take miglustat and for 3 months after stopping it. Check with your doctor if you have questions about effective birth control.
- Miglustat may cause diarrhea, especially when you begin taking it. If this occurs, check with your doctor or pharmacist for ways to treat diarrhea. 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. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- 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 old; safety and effectiveness in these children have not been confirmed.
- Miglustat may affect growth rate in CHILDREN and TEENAGERS in some cases. They may need regular growth checks while they use miglustat.
- PREGNANCY and BREAST-FEEDING: Miglustat may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using miglustat while you are pregnant. It is not known 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; constipation; cramps; diarrhea; dizziness; dry mouth; gas; headache; heaviness in the limbs; indigestion; leg cramps; loss of appetite; menstrual disorders; nausea; stomach bloating, pain, or upset; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; 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; flu-like symptoms (eg, fever, chills); memory loss; migraine; new or worsening tremors; severe or persistent diarrhea; unsteady gait; unusual bleeding or bruising; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include burning, numbness, or tingling; dizziness.Proper storage of miglustat:
Store miglustat at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep miglustat out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take miglustat or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about miglustat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to miglustat. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using miglustat.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.