Zavesca Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Zavesca?

Zavesca (miglustat) is a metabolic agent used in the treatment of mild to moderate type 1 Gaucher disease by people who cannot receive enzyme replacement therapy.

What Are Side Effects of Zavesca?

Zavesca may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
tremor or uncontrolled shaking (especially in your hands),
numbness or tinging in your hands or feet,
burning pain in your hands or feet,
severe diarrhea,
weight loss,
easy bruising, and
unusual bleeding (nosebleeds, bleeding gums)

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Zavesca include:

nerve problems (numbness, tingling, and tremor (shaking) of the hands),
diarrhea,
decreased appetite,
weight loss,
gas,
abdominal pain,
constipation,
muscle cramps or weakness,
headache,
dizziness, or
vision problems.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Zavesca

The recommended dose of Zavesca for the treatment of adult patients with type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals.

What Drugs, Substances, or Supplements Interact with Zavesca?

Zavesca may interact with imiglucerase (Cerezyme). Tell your doctor all medications and supplements you use.

Zavesca During Pregnancy and Breastfeeding

Zavesca is known to cause birth defects. Do not take Zavesca during pregnancy. It is unknown if this drug passes into breast milk and if it will affect a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Zavesca (miglustat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow

Zavesca Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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 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.

QUESTION

About how much does an adult human brain weigh? See Answer

Zavesca Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
Tremor [see WARNINGS AND PRECAUTIONS]
Diarrhea and Weight Loss [see WARNINGS AND PRECAUTIONS]
Reductions in Platelet Count [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure of 80 patients with type 1 Gaucher disease in two open-label, uncontrolled, monotherapy trials, one open-label, active-controlled trial, and two extensions, who received ZAVESCA at doses ranging from 50 mg to 200 mg three times daily. Patients were aged 18 to 69 years at first treatment. The population was evenly distributed by gender.

The most common serious adverse reaction reported with ZAVESCA treatment in clinical trials was peripheral neuropathy [see WARNINGS AND PRECAUTIONS].

The most commonly reported adverse reactions in patients treated with ZAVESCA (occurring in ≥5%) that were considered related to ZAVESCA are shown in Tables 1 and 2 [see WARNINGS AND PRECAUTIONS].

The most common adverse reactions requiring intervention were diarrhea and tremor [see WARNINGS AND PRECAUTIONS].

In two open-label, uncontrolled monotherapy trials, adult type 1 Gaucher disease patients were treated with ZAVESCA at a starting dose of 100 mg three times daily (dose range 100 to 200 mg three times daily) for up to 12 months in 28 patients [Study 1], or at a dose of 50 mg three times daily for up to 6 months in 18 patients [Study 2]. Table 1 below lists adverse reactions that occurred during the trials in ≥5% of patients.

Table 1: Adverse Reactions in ≥5% of Patients in Two Open-Label, Uncontrolled Monotherapy Trials of ZAVESCA

	Incidence of adverse reactions
	Study 1 (starting dose 100 mg three times daily)	Study 2 (50 mg three times daily)
Patients entered in Study (n)	28	18
Body System - Preferred Term	% of patients reporting	% of patients reporting
Gastrointestinal System
Diarrhea	89	89
Flatulence	29	44
Abdominal Pain	18	50
Nausea	14	22
Vomiting	4	11
Bloating	0	6
Anorexia	7	0
Dyspepsia	7	0
Epigastric pain not food-related	0	6
Metabolic and Nutritional Disorders
Weight Decrease	39	67
Central and Peripheral Nervous System
Headache	21	22
Tremor	11	11
Dizziness	0	11
Leg cramps	4	11
Paresthesia	7	0
Migraine	0	6
Vision Disorders
Visual Disturbance	0	17
Musculoskeletal Disorders
Cramps	0	11
Platelet, Bleeding, and Clotting Disorders
Thrombocytopenia	7	6
Reproductive disorders, female
Menstrual disorder	0	6

In an open-label, active-controlled study, 36 adult type 1 Gaucher disease patients were treated with ZAVESCA, imiglucerase, or ZAVESCA plus imiglucerase [Study 3] for up to 12 months. Table 2 lists adverse reactions that occurred during the trial in ≥5% of patients.

Table 2: Adverse Reactions in ≥5% of Patients in Open-Label Active Controlled Study

	Incidence of adverse reactions
	ZAVESCA alone	Imiglucerase alone
Patients entered in Study (n)	12	12
Body System - Preferred Term	% of patients reporting	% of patients reporting
Gastrointestinal System
Diarrhea	100	0
Abdominal Pain	67	0
Flatulence	50	0
Constipation	8	0
Nausea	8	0
Dry Mouth	8	0
Body as a Whole
Pain	0	8
Generalized weakness	17	0
Abdominal distension	8	0
Back pain	8	0
Heaviness in limbs	8	0
Metabolic and Nutritional Disorders
Weight Decrease	67	0
Central and Peripheral Nervous System
Tremor	17	0
Dizziness	8	0
Leg cramps	8	0
Unsteady gait	8	0
Psychiatric disorders
Memory loss	8	0

DRUG INTERACTIONS

While co-administration of ZAVESCA appeared to increase the clearance of imiglucerase by 70%, these results are not conclusive because of the small number of patients studied and because patients took variable doses of imiglucerase [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Zavesca (Miglustat)