Zavesca
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Zavesca
Zavesca Side Effects Center
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 most common serious adverse reaction reported with Zavesca (miglustat) treatment in clinical studies was peripheral neuropathy (see WARNINGS: Peripheral Neuropathy).
The most common treatment-emergent adverse events reported in clinical studies with Zavesca (miglustat) were weight loss, diarrhea, and tremor (see PRECAUTIONS: Tremor, and Diarrhea and Weight Loss). Other common adverse reactions were flatulence, abdominal pain, headache, and influenza-like symptoms.
The most common adverse reaction requiring intervention was diarrhea (see PRECAUTIONS: Diarrhea and Weight Loss). Most episodes of diarrhea were ameliorated by the use of anti-diarrheal medications, and/or the avoidance of high carbohydrate content foods, or were noted to decrease over time with continued Zavesca (miglustat) treatment. The next most common adverse reaction requiring intervention was tremor (see PRECAUTIONS: Tremor). In many cases, tremor resolved despite continued Zavesca (miglustat) treatment. Dose reduction of Zavesca (miglustat) may ameliorate tremor, but discontinuation of Zavesca (miglustat) was required in some patients.
The data described below reflect exposure of 80 adult type 1 Gaucher disease patients to Zavesca (miglustat) in two open-label, uncontrolled, monotherapy trials, and one open-label, active-controlled trial. Patients were ages 18 to 69 years at first treatment. The population was nearly evenly distributed by gender.
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.
In two open-label, uncontrolled monotherapy trials, adult type 1 Gaucher disease patients were treated with ZAVESCA® (miglustat) 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 9 below enumerates adverse events that occurred during the trials in ≥ 5% of patients. Reported adverse events have been classified using standard WHO ART terms.
Table 9: Adverse Reactions in ≥ 5% of Patients in Two Open-Label,
Uncontrolled Monotherapy Trials of ZAVESCA® (miglustat)
| Incidence of adverse reaction | ||
| 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 Cramps legs | 04 | 11 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 (versus Cerezyme; imiglucerase), 36 adult type 1 Gaucher disease patients were treated with ZAVESCA® (miglustat) , Cerezyme, or ZAVESCA® (miglustat) + Cerezyme (Study 3) for up to 12 months. Table 10 enumerates adverse events that occurred during the trial in ≥ 5% of patients. Reported adverse events have been classified using standard WHOART terms.
Table 10: Adverse Reactions In ≥ 5% of Patients in Open-Label
Active Controlled Study
| Incidence of adverse reaction | |||
| ZAVESCA® alone | Cerezyme alone | ZAVESCA® + Cerezyme | |
| Patients entered in Study (n) | 12 | 12 | 12 |
| Body System - Preferred Term | % of patients reporting | % of patients reporting | % of patients reporting |
| Gastrointestinal System | |||
| Diarrhea | 100 | 0 | 83 |
| Abdominal Pain | 67 | 0 | 58 |
| Flatulence | 50 | 0 | 42 |
| Constipation | 8 | 0 | 25 |
| Nausea | 8 | 0 | 8 |
| Mouth dry | 8 | 0 | 0 |
| Body as a Whole | |||
| Influenza-Like Symptoms | 0 | 0 | 8 |
| Pain | 0 | 8 | 8 |
| Pain legs | 0 | 0 | 8 |
| Weakness generalized | 17 | 0 | 8 |
| Abdominal distension | 8 | 0 | 8 |
| Back pain | 8 | 0 | 0 |
| Abdominal distension gaseous | 8 | 0 | 0 |
| Chills | 0 | 0 | 8 |
| Heaviness in limbs | 8 | 0 | 0 |
| Metabolic and Nutritional Disorders | |||
| Weight Decrease | 67 | 0 | 42 |
| Central and Peripheral Nervous System | |||
| Tremor | 17 | 0 | 33 |
| Dizziness | 8 | 0 | 25 |
| Cramps legs | 8 | 0 | 0 |
| Gait unsteady | 8 | 0 | 0 |
| Numbness localized | 0 | 0 | 8 |
| Shaking | 0 | 0 | 8 |
| Psychiatric disorders | |||
| Appetite absent | 0 | 0 | 8 |
| Jitteriness | 0 | 0 | 8 |
| Memory loss | 8 | 0 | 0 |
| Vision Disorders | |||
| Eye abnormality | 0 | 0 | 8 |
| Visual disturbance | 0 | 0 | 8 |
| Reproductive disorders, female | |||
| Menstrual irregularity | 0 | 0 | 8 |
Read the entire FDA prescribing information for Zavesca (Miglustat) »
Additional Zavesca Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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