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eliglustat

Generic Name: eliglustat (EL i GLOO stat)
Brand Name: Cerdelga

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 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 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; or

  • severe kidney disease.

To make sure eliglustat is safe for you, 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.

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.

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. Your doctor may occasionally change your dose. 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.

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.

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?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next 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?

Do not take 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 cause unwanted side effects. Avoid the use of grapefruit products while taking eliglustat.

Eliglustat side effects

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;

  • 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.

Side Effects (complete list)

Eliglustat dosing information

Usual Adult Dose for Gaucher Disease:

CYP450 2D6 Extensive metabolizers (EMs) and Intermediate Metabolizers (IMs): 84 mg orally twice a day
CYP450 2D6 Poor Metabolizers (PMs): 84 mg orally once a day
EMs and IMs taking strong or moderate CYP450 2D6 inhibitors: 84 mg orally once a day
EMs taking strong or moderate CYP450 3A inhibitors: 84 mg orally once a day

Comments: It is recommended to establish the CYP450 2D6 genotype of each patient using an FDA-cleared test before starting treatment.

Use: Long-term treatment of patients with Gaucher disease type 1 who are CYP450 2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers.

What other drugs will affect eliglustat?

Eliglustat can cause a serious heart problem, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, cancer medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01.

Date modified: December 03, 2017
Last reviewed: September 19, 2017

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