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Zavesca

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Zavesca

Side Effects
Interactions

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 Zavesca (miglustat) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

While co-administration of Zavesca appeared to increase the clearance of imiglucerase by 70%, these results are not conclusive because of the small number of patients studied and because patients took variable doses of imiglucerase [see CLINICAL PHARMACOLOGY].

Read the Zavesca Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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