eliglustat

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Pronunciation: EL i GLOO stat

Brand: Cerdelga

What is the most important information I should know about eliglustat?

You should not use eliglustat if you have severe liver disease.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. 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.

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:

  • 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 severe liver disease.

To make sure eliglustat is safe for you, tell your doctor if you have:

  • long QT syndrome or other heart rhythm disorder;
  • heart disease or prior heart attack;
  • liver disease; or
  • kidney disease.

FDA pregnancy category C. It is not known whether eliglustat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether eliglustat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

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. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

You may take eliglustat with or without food. Take the medicine at the same time each day.

Do not crush, open, or dissolve an eliglustat capsule. Swallow it whole.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Use eliglustat regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose of eliglustat, skip the missed dose and only take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

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?

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking eliglustat.

Grapefruit and grapefruit juice may interact with eliglustat and lead to unwanted side effects. Avoid the use of grapefruit products while taking eliglustat.

What are the possible side effects of eliglustat?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain;
  • a light-headed feeling, like you might pass out; or
  • pounding heartbeats or fluttering in your chest.

Common side effects may include:

  • diarrhea, nausea, stomach pain;
  • headache;
  • 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?

Many drugs can interact with eliglustat. Not all possible interactions are listed here. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE, and any you start or stop using during treatment with eliglustat, especially:

  • anagrelide;
  • droperidol;
  • methadone;
  • ondansetron;
  • an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
  • cancer medicine--arsenic trioxide, vandetanib;
  • an antidepressant--citalopram, escitalopram;
  • anti-malaria medication--chloroquine, halofantrine;
  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
  • medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete and many other drugs can interact with eliglustat. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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