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)

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

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

While co-administration of ZAVESCA® (miglustat) appeared to increase the clearance of Cerezyme by 70%, these results are not conclusive because of the small number of subjects studied and because patients took variable doses of Cerezyme. Combination therapy with Cerezyme (imiglucerase) and ZAVESCA (miglustat) ® is not indicated (see CLINICAL PHARMACOLOGY, Drug Interactions).

Last reviewed on RxList: 1/11/2011
This monograph has been modified to include the generic and brand name in many instances.