Eliglustat Oral capsule

What is this medicine?

ELIGLUSTAT (el i GLOO stat) is used for the long-term treatment of adults with Gaucher disease type I. Eliglustat is not used in certain people with Gaucher disease type 1. Your doctor will perform a test to make sure this medicine is right for you.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do no take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dofetilide

• dronedarone

• grapefruit juice

• pimozide

• quinidine

• quinine

• ritonavir

• saquinavir

• tipranavir

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• colchicine

• dabigatran

• digoxin

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• ranitidine

• rifampin

• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Certain genetic factors may reduce the effect of this medicine. Your doctor may use genetic tests to determine treatment.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heart beat; palpitations; feeling faint or lightheaded, falls; breathing problems

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• nausea

• pain in the arms, legs, or back

• stomach pain

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.