Eliglustat Oral capsule

ELIGLUSTAT (el i GLOO stat) treats Gaucher disease. It works by decreasing the amount of fatty substances (lipids) your body makes, which prevents the buildup of lipids in the spleen, liver, and other tissues. This decreases symptoms.

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Fatigue
• Headache
• Nausea
• Stomach pain

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

They need to know if you have any of these conditions:

• Heart disease
• History of heart attack
• History of irregular heartbeat
• Kidney disease
• Liver disease
• An unusual or allergic reaction to eliglustat, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with any of the following:

• Adagrasib
• Berotralstat
• Cisapride
• Dronedarone
• Grapefruit juice
• Pimozide
• Quinidine
• Quinine
• Ritonavir
• Saquinavir
• Thioridazine
• Tipranavir

This medication may also interact with the following:

• Antiviral medications for HIV or AIDS
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for fungal infections, such as ketoconazole and itraconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Colchicine
• Dabigatran
• Digoxin
• Dofetilide
• Other medications that cause heart rhythm changes
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Ranitidine
• Rifampin
• St. John's wort
• Ziprasidone

If you miss a dose, take the next dose at the usual time. Do not take double or extra doses.

Tell your care team if your symptoms do not start to get better or if they get worse.

Certain genetic factors may reduce the effect of this medication. Your care team may use genetic tests to determine treatment.