What is the most important information I should know about eliglustat?
You should not use eliglustat if you have severe liver or kidney disease.
Eliglustat can cause a serious heart problem, especially if you use certain other medicines at the same time. Tell your doctor about all medicines you use.
What is eliglustat?
Eliglustat 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.
Eliglustat is used to treat mild to moderate type 1 Gaucher disease in adults. Eliglustat is used only if a specific liver enzyme (2D6) in your body breaks down or metabolizes drugs at a certain rate.
Eliglustat may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, eliglustat is not a cure for this condition.
Eliglustat may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking eliglustat?
Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of eliglustat, which may cause side effects or make eliglustat less effective. Eliglustat can also affect blood levels of certain other drugs, making them less effective or increasing side effects.
Your doctor may need to change your treatment plan if you use any of the following drugs:
- St. John's wort;
- antifungal medicine;
- tuberculosis medicine;
- seizure medicine;
- heart or blood pressure medications;
- an antidepressant; or
- medicine to treat a mental illness.
You should not use eliglustat if you are allergic to it, or if you have:
Tell your doctor if you have ever had:
- long QT syndrome or other heart rhythm disorder;
- heart disease or a heart attack;
- liver disease; or
- kidney disease.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
Eliglustat is not approved for use by anyone younger than 18 years old.
How should I take eliglustat?
Your doctor will perform a genotype blood test to make sure eliglustat is the right treatment for you.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
If you switched to eliglustat from another enzyme replacement medicine, wait at least 24 hours after your last dose of the other medicine before you start taking eliglustat.
Eliglustat is usually taken 1 or 2 times per day, based on the results of your genotype test. Follow your doctor's dosing instructions very carefully.
Take this medicine with a full glass of water.
Take the medicine at the same time each day, with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Eliglustat can cause a serious heart problem. Your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG) before you take this medicine.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking eliglustat?
Grapefruit may interact with eliglustat and lead to unwanted side effects. Avoid the use of grapefruit products.
What are the possible side effects of eliglustat?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden dizziness (like you might pass out); or
- fast or pounding heartbeats, fluttering in your chest.
Common side effects may include:
- diarrhea, nausea, stomach pain;
- back pain; or
- pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect eliglustat?
Eliglustat can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Many drugs can affect eliglustat, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about eliglustat.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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