Zavesca reduces the formation of a certain protein in the body in people with type 1 Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Zavesca is used to treat mild to moderate type 1 Gaucher disease by people who cannot receive enzyme replacement therapy.

Zavesca may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, it is not a cure for this condition.

Zavesca may also be used for purposes not listed in this medication guide.

Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking Zavesca. Contact your doctor immediately if you experience new or worsening numbness, tingling, or burning in the hands, arms, legs, or feet or tremor in the hands.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Zavesca exactly as directed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Zavesca is usually taken 3 times per day. Take the medicine at the same time each day.

Your doctor will need to check your nerve and muscle function every 6 months while you are using Zavesca.

Use Zavesca regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Gaucher Disease:

Initial dose: 100 mg orally 3 times a day at regular intervals

You should not use Zavesca if you are allergic to miglustat.

To make sure Zavesca is safe for you, tell your doctor if you have:

• stomach problems;

• an intestinal disorder such as ulcerative colitis;

• kidney disease; or

• a condition that causes tremors.

Miglustat may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

It is not known whether miglustat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Zavesca.

Do not give Zavesca to anyone under 18 years old without medical advice.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Zavesca can cause diarrhea, which may be serious. Your doctor may prescribe anti-diarrhea medicine and may also recommend changes in your diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any signs of an allergic reaction to Zavesca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• tremor or uncontrolled shaking, especially in your hands;

• numbness, tingling, or burning pain in your hands or feet;

• severe diarrhea and weight loss; or

• easy bruising or bleeding (nosebleeds, bleeding gums).

Common Zavesca side effects may include:

• gas, constipation, bloating;

• nausea, vomiting, stomach pain, indigestion, loss of appetite, weight loss;

• dry mouth;

• dizziness, weakness;

• headache (including migraine);

• back pain, muscle cramps, leg cramps;

• pain or heavy feeling in your arms or legs;

• memory problems, feeling unsteady, loss of balance;

• burning pain in your hands or feet;

• vision problems; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with miglustat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.