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Zavesca

Generic Name: miglustat (mi GLOO stat)
Brand Names: Zavesca
Zavesca is used in the treatment of mild to moderate type 1 Gaucher disease. Learn about side effects, interactions and indications.
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Drug Information:
Zavesca (miglustat) reduces the formation of a certain protein in the body in people with type 1 Gaucher disease. Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured. Zavesca is used to treat mild to moderate type 1 Gaucher disease by people who cannot receive enzyme replacement Therapy. Learn more

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Zavesca Side Effects

Note: This document contains side effect information about miglustat. Some of the dosage forms listed on this page may not apply to the brand name Zavesca.

For the Consumer

Applies to miglustat: oral capsule

Along with its needed effects, miglustat (the active ingredient contained in Zavesca) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking miglustat:

More common

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • pinpoint red spots on the skin
  • trembling or shaking in the hands
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • weakness in the arms, hands, legs, or feet
  • weight loss

Some side effects of miglustat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • bloated or full feeling
  • blurred or loss of vision
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • dizziness
  • double vision
  • dry mouth
  • excess air or gas in the stomach or intestines
  • halos around lights
  • headache
  • heartburn
  • heaviness in the limbs
  • indigestion
  • leg cramps
  • loss of appetite
  • memory loss
  • menstrual changes
  • nausea
  • pain or discomfort in the chest, upper stomach, or throat
  • passing gas
  • stomach discomfort, upset or pain
  • swelling of the abdominal or stomach area
  • tunnel vision
  • unsteady walk
  • vomiting

For Healthcare Professionals

Applies to miglustat: oral capsule

General

The most commonly reported adverse reactions included diarrhea, flatulence, abdominal pain, weight loss, and tremor; the most common serious adverse reaction was peripheral neuropathy; diarrhea and tremor were the side effects that most commonly required intervention.

Gastrointestinal

Osmotic diarrhea appears to be due to inhibitory activity of miglustat (the active ingredient contained in Zavesca) on intestinal disaccharidases leading to reduced absorption of dietary disaccharides in the small intestine. Diarrhea decreased over time with continued therapy.

Very common (10% or more): Diarrhea (including osmotic diarrhea; up to 100%), abdominal pain (up to 67%), flatulence (up to 50%), nausea (up to 22%), vomiting (up to 11%)

Common (1% to 10%): Constipation, dry mouth, dyspepsia, epigastric pain not food-related, bloating, stomach pain, gas, abdominal distension/discomfort

Frequency not reported: Dysphagia, indigestion, dry mouth

Metabolic

Weight loss has been observed in approximately 55% to 65% of patients. Peak weight loss occurs between 6 and 12 months, with a mean weight loss of 6% to 7% of body weight. It is unclear if weight loss results from the diarrhea and associated gastrointestinal complaints, a decrease in food intake, or a combination of these or other factors. There is a trend to return to baseline weight after the first year.

Very common (10% or more): Weight decrease (up to 67%)

Common (1% to 10%): Anorexia

Nervous system

Very common (10% or more): Tremor/exacerbation of existing tremor (about 30%), headache (up to 22%), tremor (up to 17%), dizziness (up to 11%)

Common (1% to 10%): Unsteady gait, paresthesia, migraine, peripheral neuropathy, ataxia, hypoesthesia

Frequency not reported: Gait abnormal, gait spastic, hyperreflexia

The most common serious adverse reaction in clinical trials was peripheral neuropathy. Tremor, and worsening tremor were very commonly reported. Compared to the general population, patients with type 1 Gaucher disease are more likely to have peripheral neuropathy. A patient should be evaluated for tremor and neuropathy prior to starting therapy.

Other

Very common (10% or more): Generalized weakness (up to 17%)

Common (1% to 10%):Fatigue, asthenia, chills, malaise, pain

Frequency not reported: Fatigue, lacerations

Ocular

Very common (10% or more): Visual disturbances (up to 17%)

Musculoskeletal

Very common (10% or more): Cramps (up to 11%)

Common (1% to 10%): Muscle spasms

Frequency not reported: Leg cramps, muscle cramps, back pain, heaviness in arms and legs

Psychiatric

Common (1% to 10%): Memory loss

Frequency not reported: Insomnia, decreased appetite, depression, decreased libido

Hematologic

Common (1% to 10%): Thrombocytopenia

Frequency not reported: Mild reduction in platelet count

Genitourinary

Common (1% to 10%): Menstrual disorder

Respiratory

Frequency not reported: Nasopharyngitis, cough, sinusitis

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Zavesca (www.drugs.com/zavesca.html).