Zavesca

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 2/7/2022
Zavesca Side Effects Center

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?

Common side effects of Zavesca include:

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.

QUESTION

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

Read the entire detailed patient monograph for Zavesca (Miglustat)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
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 100mgthree times daily)
Study 2
(50mgthree times daily)
Patients entered in Study (n)2818
Body System-Preferred Term Gastrointestinal System% of patients reporting% of patients reporting
  Diarrhea8989
  Flatulence2944
  Abdominal Pain1850
  Nausea1422
  Vomiting411
  Bloating06
  Anorexia70
  Dyspepsia70
  Epigastric pain not food-related06
Metabolic and Nutritional Disorders
  Weight Decrease3967
Central and Peripheral Nervous System
  Headache2122
  Tremor1111
  Dizziness011
  Leg cramps411
  Paresthesia70
  Migraine06
Vision Disorders
  Visual Disturbance017
Musculoskeletal Disorders
  Cramps011
Platelet, Bleeding, and Clotting Disorders
  Thrombocytopenia76
Reproductive disorders, female
  Menstrual disorder06

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 Patientsin Open-Label Active Controlled Study

Incidence of adverse reactions
ZAVESCA aloneImiglucerase alone
Patients entered in Study (n)1212
Body System-PreferredTerm Gastrointestinal System% of patients reporting% of patients reporting
  Diarrhea1000
  Abdominal Pain670
  Flatulence500
  Constipation80
  Nausea80
  Dry Mouth80
Body as a Whole
  Pain08
  Generalized weakness170
  Abdominaldistension80
  Back pain80
  Heaviness in limbs80
Metabolic and Nutritional Disorders
  Weight Decrease670
Central and Peripheral Nervous System
  Tremor170
  Dizziness80
  Leg cramps80
  Unsteady gait80
Psychiatric disorders
  Memory loss80

Read the entire FDA prescribing information for Zavesca (Miglustat)

© 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.

Health Solutions From Our Sponsors