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Zavesca

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Zavesca

Zavesca

Zavesca Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zavesca in Detail - Patient Information: Side Effects

Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking miglustat. 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.

Seek emergency medical attention if you experience a rare but serious allergic reaction to miglustat including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives.

Other less serious side effects may be more likely to occur. Continue to take miglustat and talk to your doctor if you experience:

  • diarrhea;
  • decreased appetite or weight loss;
  • gas or abdominal pain;
  • constipation;
  • muscle cramps or weakness;
  • headache;
  • dizziness; or
  • vision problems.

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zavesca (Miglustat) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zavesca FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 open-label, 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
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

Read the entire FDA prescribing information for Zavesca (Miglustat) »

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