1 What is Zavesca?

Brand: Zavesca

Generic: Miglustat

Zavesca is a prescription medicine orally administered to treat mild to moderate type 1 Gaucher disease. It is used in patients who cannot undergo an enzyme replacement therapy as a primary treatment for Gaucher diseases.

When you have type 1 Gaucher disease, you lack a naturally-occurring enzyme needed to break down glucosylceramide, another natural chemical in the body.

When this happens, too much glucosylceramide can cause enlargement of the liver and spleen, changes in blood, and bone disease.Miglustat is used to stop the body from producing glucosylceramide.

2 What to Know Before Using

If you are about to start Zavesca, speak with your doctor about what you need to know. The risks and benefits the medicine offer must be weighed.

In using Zavesca, you and your doctor must consider the following:

Allergies. If you have any unusual reaction to any medicine, be sure to tell your doctor about it. Additionally, disclose other types of allergies - foods, preservatives, animals, or dyes, if there are any. Read the package ingredients carefully and make sure you are not allergic to any of its ingredients.

Pediatric. There are no appropriate studies performed to establish safety and efficacy of miglustat use in children.

Geriatric. While there is no appropriate study done to point out the relationship of old age to the effects of this drug, no geriatric-related problems are given to date. Nonetheless, utmost caution must be considered when giving this medicine to the elderly, since the age group is more likely to suffer from age-related kidney, liver, or heart diseases.

Pregnancy. While there are no adequate studies done with pregnant women, animal tests show that miglustat has an adverse effect on the unborn fetus.

Breastfeeding. Although there are no adequate studies in lactating mothers that determine potential risk in an infant when breastfeeding, the potential benefits should be weighed against the risks before taking this medication.

Drug Interactions. Certain medicines have adverse effects when used together. Make sure to inform your doctor about other drugs you are taking, so that alterations and precautions will be made if necessary.

Before using miglustat, talk to your doctor about possible interactions if you are taking other medications. It is also important to inform your doctor if you are smoking tobacco or drinking alcohol since these may interact with the drug’s effectiveness.

Other medical problems. If you have other health problems, it may affect the use of miglustat. Make sure you inform your doctor about other problems concerning your health, especially diarrhea, tremors, in which miglustat must be used with caution.

This is the same with mild kidney disease. In the case of a severe kidney condition, miglustat is not recommended.

3 Proper Usage

To use Zavesca properly, you must follow all instructions given by your doctor. The dose of Zavesca depends on the patient's age, weight, and symptoms, as well as the strength of the medicine.

Do not change the dosage the doctor indicated unless he or she told you otherwise. The number of doses and the number of hours between doses generally depend on the reason why you are taking miglustat.

Generally, dosage will be as follows: In adults with type 1 Gaucher disease, your doctor may prescribe 100 mg to be taken three times a day. Dosage may be adjusted as per doctor’s advice.

Missed dose: Take the missed dose as soon as possible. In case it is almost time for the next dose, skip the missed one and follow your regular dosing schedule. Never take double doses.

Storage: Keep the medicine in an airtight container at normal room temperature. Keep it away from direct light, heat, and moisture. Do not let it freeze.

Do not take it out from the blister pack unless it is your time to take the medicine. Keep the medicine out of children’s reach.

4 Precautions to Take

Before using Zavesca, there are some precautions you must take. Regular visits to the doctor are important to determine if the medicine is properly working. To check unwanted side effects before and during treatments, blood tests, and neurological exams may be required.

If you feel numbness, burning, painful, or tingling sensations in the hands, arms, legs, and feet, check with your doctor right away. These could mean other underlying condition like peripheral neuropathy.

Intake of miglustat may lower the level of platelets in the blood; hence, close monitoring during therapy is crucial. Taking this medicine may also cause hand tremors, or worsen existing tremors.

The most common side effect of miglustat is diarrhea, so it is possible that your doctor may also prescribe anti-diarrheal medication in case this side effect manifested. Changes in diet and weight loss program may be recommended, as well.

5 Potential Side Effects

Make sure you meet with your doctor in using Zavesca to avoid unwanted potential side effects. Not all people may suffer from these side effects, but if they do, immediate medical attention may be needed.

Contact your doctor as soon as possible if you encounter any of the following:

  • black, tarry stools
  • weight loss
  • blood in the urine or stools
  • disturbed color perception
  • unsteadiness or awkwardness
  • diarrhea
  • pinpoint red spots on the skin
  • bleeding gums
  • trembling or shaking of the hands
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings unusual bleeding or bruising
  • weakness in the arms, hands, legs, or feet
  • back pain
  • menstrual changes
  • bloated or full feeling
  • double vision
  • blurred or loss of vision
  • difficulty having a bowel movement (stool)
  • unsteady walk
  • dizziness
  • dry mouth
  • pain or discomfort in the chest, upper stomach, or throat
  • stomach discomfort
  • excess air or gas in the stomach or intestines
  • swelling of the abdominal or stomach area
  • passing gas
  • unsteady walk
  • halos around lights
  • headache
  • vomiting
  • vomiting
  • heartburn
  • heaviness in the limbs
  • indigestion
  • leg cramps
  • loss of appetite
  • memory loss
  • nausea
  • tunnel vision

While most of these side effects usually diminish as the body adjusts to the drug, calling your doctor may be needed.

Some patients may experience side effects not listed above. If you want to report side effects, you may do so by calling the FDA at 1-800-FDA-1088.

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