ZavescaŽ
What is ZavescaŽ (miglustat)?
ZavescaŽ is a prescription medicine take by mouth for adults with mild to
moderate type 1 Gaucher disease. ZavescaŽ is used only in patients who
cannot be treated with enzyme replacement therapy.
How does ZavescaŽ work?
In people with type 1 Gaucher disease, the body has an excess of certain
types of fatty substances called glycosphingolipids
(gli-coh-sfing-goh-lip-ids) or GSL. Normally, the body produces GSL and a
certain enzyme breaks it down. In people with type 1 Gaucher disease
there's either not enough of the enzyme or it doesn't work properly, so the
fatty substances build up over time, causing serious problems in parts of
the body like the liver, spleen, lungs, and bones. ZavescaŽ reduces the
harmful buildup of fatty substances throughout the body by reducing the
amount of GSL the body produces. ZavescaŽ also helps increase the ability of
natural enzymes in the body to work more effectively in its cells. ZavescaŽ
helps treat the symptoms of type 1 Gaucher disease because the enzymes you
do have are able to break down the fatty substances and reduce the buildup.
ZavescaŽ has been shown to provide important benefits for people with type 1
Gaucher disease, whether they have been treated before with enzyme
replacement therapy (ERT) or they are being treated for the first time.1
Individual results may vary.
ZavescaŽ:
* Reduces swelling of the liver and spleen
* Increases amounts of hemoglobin and platelets
Taking ZavescaŽ
It's important to take ZavescaŽ as prescribed by your doctor. ZavescaŽ is the
only oral medication approved for type 1 Gaucher disease. The recommended
dose of ZavescaŽ is usually 1 pill (100 mg) 3 times a day, but your doctor
will tell you which dose is right for you.
Giving it time
ZavescaŽ may help keep your disease under control and make a positive
difference in your life. Remember, different people react to ZavescaŽ in
different ways.
Like many drugs, ZavescaŽ may cause side effects. Many of these side effects,
if they occur, may lessen or go away over time. Still, you should be aware
of side effects that may occur while you are taking ZavescaŽ.
Diarrhea is the most common side effect for people taking ZavescaŽ. Your
doctor may give you a medicine (anti-diarrheal) to manage diarrhea if it is
a problem for you, and may recommend dietary changes to reduce
high-carbohydrate foods at the start of your treatment with ZavescaŽ. Your
doctor or dietitian can also help you with developing a meal plan that is
best for you.
Talk to your physician if you have any questions about ZavescaŽ or type 1
Gaucher disease.
Important Safety Information for ZavescaŽ:
In clinical studies, the most common adverse events due to ZavescaŽ included
weight loss, diarrhea, and trembling in the hand (tremor). Other common
adverse reactions were excess gas (flatulence), abdominal pain, headache,
and influenza-like symptoms. The most common serious adverse reaction was
tingling or numbness in the hands or feet with or without pain (peripheral
neuropathy). Patients should undergo neurological examination at the start
of treatment and every 6 months thereafter; ZavescaŽ should be reassessed in
patients who develop symptoms of peripheral neuropathy. ZavescaŽ may cause
fetal harm if administered to a pregnant woman. Men should maintain reliable
contraceptive methods and not plan to father a child while taking ZavescaŽ
and for 3 months after discontinuing treatment.
Please see full prescribing information. (the link behind full prescribing
information is www.zavesca.com)
1. ZavescaŽ (miglustat) full prescribing information. Actelion
Pharmaceuticals US, Inc. 2008.
http://www.zavesca.com/pdf/Zavesca_miglustat_Prescribing_Information_08_190_03_00_1210.pdf |
