Zavesca Side Effects
Generic Name: miglustat
Please note - some side effects for Zavesca may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Zavesca - for the Consumer
Zavesca
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zavesca:
Seek medical attention right away if any of these SEVERE side effects occur when using Zavesca:Back pain; constipation; cramps; diarrhea; dizziness; dry mouth; gas; headache; heaviness in the limbs; indigestion; leg cramps; loss of appetite; menstrual disorders; nausea; stomach bloating, pain, or upset; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling sensation of the hands, arms, legs, or feet; flu-like symptoms (eg, fever, chills); memory loss; migraine; new or worsening tremors; severe or persistent diarrhea; unsteady gait; unusual bleeding or bruising; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopZavesca Side Effects - for the Professional
Zavesca
The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy.
The most common treatment-emergent adverse events reported in clinical studies with Zavesca were weight loss, diarrhea, and tremor. Other common adverse reactions were flatulence, abdominal pain, headache, and influenza-like symptoms.
The most common adverse reaction requiring intervention was diarrhea. 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 treatment. The next most common adverse reaction requiring intervention was tremor. In many cases, tremor resolved despite continued Zavesca treatment. Dose reduction of Zavesca may ameliorate tremor, but discontinuation of Zavesca was required in some patients.
The data described below reflect exposure of 80 adult type 1 Gaucher disease patients to Zavesca 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 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 WHOART terms.
| 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 | 0 | 11 |
| Cramps legs | 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 (versus Cerezyme; imiglucerase), 36 adult type 1 Gaucher disease patients were treated with Zavesca, Cerezyme, or Zavesca + 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.
| 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 |
Side Effects by Body System - for Healthcare Professionals
Gastrointestinal
Osmotic diarrhea appears to be the result of the disaccharidase inhibitory activity of miglustat.
Gastrointestinal side effects have included diarrhea (67% to 89%), flatulence (29% to 70%), abdominal pain (18% to 50%), nausea (14% to 35%), vomiting (30% to 33%), dysphagia (20% to 25%), and abdominal distension (20%). Epigastric pain not food-related, dyspepsia, dry mouth, constipation, anorexia, and bloating have also been reported.
Nervous system
Nervous system side effects have included headache (30% to 45%), tremors (30% to 40%), gait abnormal (33%), exacerbation of existing tremor (25% to 30%), gait spastic (25%), ataxia (25%), hyperreflexia (25%), and paresthesia (20%). Dizziness, cramps in legs, unsteady gait, and migraine have also been reported.
Metabolic
Metabolic side effects including weight decrease has been reported in 25% to 65% of patients.
Ocular
Ocular side effects have included visual disturbances.
Hematologic
Hematologic side effects have included thrombocytopenia.
Genitourinary
Genitourinary side effects have included menstrual disorder in the female patient.
General
General side effects have included abdominal distension (20%), abdominal distension with gas, generalized weakness, back pain, and heaviness in limbs.
Respiratory
Respiratory side effects have included nasopharyngitis (33% to 35%), cough 33%, and sinusitis (25%).
Psychiatric
Psychiatric side effects have included insomnia (30%), decreased appetite (25%), and depression (20%).
Other
Other side effects have included fatigue (35% to 42%) and lacerations (20%).
TopMore Zavesca resources
- Zavesca Prescribing Information (FDA)
- Zavesca Monograph (AHFS DI)
- Zavesca Advanced Consumer (Micromedex) - Includes Dosage Information
- Zavesca Consumer Overview
- Zavesca MedFacts Consumer Leaflet (Wolters Kluwer)
- Miglustat Professional Patient Advice (Wolters Kluwer)
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