Eliglustat

Eliglustat is used to treat Gaucher disease type 1 (a condition in which a certain fatty substance is not broken down normally in the body and builds up in some organs and causes liver, spleen, bone, and blood problems) in certain people. Eliglustat is in a class of medications called enzyme inhibitors. It works by preventing the body from producing the fatty substance so that less of it will build up in the body and cause symptoms.

Eliglustat comes as a capsule to take by mouth. It is usually taken once or twice daily with or without food. Take eliglustat at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eliglustat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Some people may respond differently to eliglustat based on their heredity or genetic make-up. Your doctor will order a blood test to help find the dose of eliglustat that is best for you.

Swallow the capsules whole with water; do not split, open, dissolve, or crush them.

Eliglustat controls Gaucher disease but does not cure it. Continue to take eliglustat even if you feel well. Do not stop taking eliglustat without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking eliglustat,

• tell your doctor and pharmacist if you are allergic to eliglustat, any other medications, or any of the ingredients in eliglustat capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amitriptyline; certain medications for abnormal heartbeat such as amiodarone (Nexterone, Pacerone), digoxin (Lanoxin), quinidine (in Nuedexta), procainamide, and sotalol (Betapace, Sorine, Sotylize); bupropion (Aplenzin, Zyban, in Contrave); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac), digoxin; diltiazem (Cardizem, Tiazac, others); duloxetine (Cymbalta); erythromycin; fluconazole (Diflucan); fluoxetine (Prozac, Sarafem); indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), metoprolol (Toprol); nefazodone, nelfinavir (Viracept), paroxetine (Paxil); rifampin (Rifadin, Rimactane); ritonavir (Norvir, in Kaletra, in Viekira Pak), medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); sertraline (Zoloft); terbinafine (Lamisil); and verapamil (Calan, Verelan, others); Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with eliglustat, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Also tell your doctor or pharmacist if you are taking the following medications: an enzyme replacement therapy such as imiglucerase (Cerezyme), taliglucerase alfa (Elelyso), or velaglucerase alfa (Vpriv). You will need to wait 24 hours after the last dose of these enzyme replacement medications before you begin to take eliglustat.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have liver disease. Based on the results of your blood test to determine your genetic make-up, your doctor may tell you not to take eliglustat as certain people should not take the medication alone or in combination with other medications, if they have liver disease, or if they have a combination of certain medical conditions and medications.

• tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), or another type of irregular heartbeat or heart rhythm problem, or if you have or have ever had a heart attack, heart failure, or heart, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking eliglustat, call your doctor.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

If you miss a dose, take the next dose at the usual time and continue your dosing schedule. Do not take a double dose to make up for a missed one.

• Eliglustat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • fatigue

  • weakness

  • joint pain

  • headache

  • migraine

  • nausea

  • heartburn

  • gas

  • mouth and throat pain

  • diarrhea

  • back pain

  • pain in legs or arms

  • stomach pain

  • cough

  • rash

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • heart palpitations, dizziness, or fainting

• Eliglustat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• dizziness

• unsteadiness

• nausea

• vomiting

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to eliglustat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.