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Talk to your doctor before you start taking Zavesca, and keep in touch with him or her as your therapy continues. Good communication with your doctor is key to successful Zavesca therapy.


Peripheral Neuropathy

The most serious adverse effect reported in the Zavesca clinical trials was peripheral neuropathy (nerve problems in the arms, hands, legs, or feet).2 In the Zavesca clinical trials, 2 people decided to stop taking Zavesca because of peripheral neuropathy. If you experience any tingling, numbness, or burning in your hands, arms, legs, or feet, contact your doctor immediately. Your doctor will probably want to talk to you about your experience with Zavesca and perform some tests; you may have to reduce your dose or stop taking Zavesca entirely.2 Your doctor will test your nervous system before you start taking Zavesca and every six months while you continue to take it.2

 
Tell your doctor immediately if you experience tingling, numbness, or burning in your hands, arms, legs, or feet.

 

Birth Defects

Zavesca may cause birth defects if you take it while you are pregnant.2 If you are pregnant or if you could become pregnant, you should talk to your doctor about the risk of birth defects before you begin to take Zavesca. You must use reliable birth control while you are taking Zavesca.

Sperm Changes

Zavesca may cause changes in sperm development and function. If you are a man, you should use birth control while you are taking Zavesca, and you should not father a child for at least 3 months after you stop taking Zavesca.2

Tremor

Some people taking Zavesca in the clinical trials also experienced mild-to-moderate tremor (shaky hands).2,3 If you notice any tremor while you are taking Zavesca, contact your doctor. In the Zavesca clinical trials, tremor disappeared either by itself within a few days, following dose reduction, or after stopping Zavesca therapy.2

Diarrhea

People in Zavesca clinical trials experienced mild-to-moderate diarrhea, but they were able to manage it with anti-diarrheal medications and dietary changes.2 People taking Zavesca also experienced some flatulence, abdominal cramps, or nausea. Be sure to talk to your doctor if you need help managing any of these common adverse effects of Zavesca.

Weight Loss

Some people taking Zavesca in the clinical trials also experienced weight loss (6%–7% of their total body weight over 12 months), but nobody stopped taking Zavesca because of it.2,3

 



1. Cox T, Lachmann R, Hollak C, et al. Novel oral treatment of Gaucher’s
disease with N-butyldeoxynojirimycin (OGT 918) to decrease substrate
biosynthesis. Lancet. 2000;355:1481-1485.
2. Zavesca® (miglustat) package insert. Actelion, Ltd. 2003.
3. Data on file, Actelion Pharmaceuticals US, Inc.

 

 



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