Enasidenib tablets

What is this medication?

ENASIDENIB (en a sid e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat acute myelogenous leukemia.

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

COMMON BRAND NAME(S): IDHIFA

What should I tell my care team before I take this medication?

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

• liver disease
• an unusual or allergic reaction to enasidenib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not 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.

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.

Overdosage: If you think you have 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 or vomit after taking it, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

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

• elagolix
• elbasvir; grazoprevir

This medicine may interact with the following medications:

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

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 medication?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for at least 2 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 2 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 2 months after stopping it.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

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
• bone pain
• breathing problems
• cough
• dizziness
• fever
• lump or swollen lymph nodes on the neck, groin, or underarm area
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• swelling of arms and legs
• fast weight gain
• yellowing of the eyes or skin

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

• decreased appetite
• diarrhea
• nausea
• vomiting

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 medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. 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.