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Zavesca

Last reviewed on RxList: 7/15/2019
Zavesca Side Effects Center

Last reviewed on RxList 7/15/2019

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. Common side effects of Zavesca include:

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

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.

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Zavesca Consumer Information

Get emergency medical help if you have any of these 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:

  • diarrhea, constipation, bloating;
  • nausea, vomiting, stomach pain, indigestion;
  • dry mouth;
  • dizziness, weakness;
  • headache (including migraine);
  • back pain, muscle cramps;
  • pain or heavy feeling in your arms or legs;
  • memory problems, feeling unsteady, loss of balance;
  • 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.

Read the entire detailed patient monograph for Zavesca (Miglustat)

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Zavesca Professional Information

SIDE EFFECTS

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

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 openlabel, uncontrolled, monotherapy trials, one open-label, active-controlled trial, and two extensions, who received Zavesca at doses ranging from 50mg 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 (occuring 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
Zavescaalone 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

Read the entire FDA prescribing information for Zavesca (Miglustat)

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© Zavesca Patient Information is supplied by Cerner Multum, Inc. and Zavesca Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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