Pronunciation: EN a SID a nib

Brand: Idhifa

What is the most important information I should know about enasidenib?

Enasidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking enasidenib.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

What is enasidenib?

Enasidenib works by blocking the function of a certain protein that has become mutated in white blood cells. This mutation keeps the blood cells from growing and functioning normally, and the build-up of these abnormal cells can lead to acute myeloid leukemia.

Enasidenib is used to treat acute myeloid leukemia in adults who have a mutation in the protein that this medicine targets and blocks.

Enasidenib is usually given after other medicines have been tried without success.

Enasidenib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking enasidenib?

You should not use enasidenib if you are allergic to it.

Before using enasidenib tell your doctor about all your medical conditions or allergies.

You may need to have a negative pregnancy test before starting this treatment. In animal studies, enasidenib caused miscarriage, low birth weight, stillbirth, and birth defects.

Enasidenib may harm an unborn baby. Use a barrier form of birth control (condom or diaphragm with spermicide) to prevent pregnancy while you are using enasidenib. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

You should use birth control to prevent pregnancy while using this medicine whether you are a man or a woman. Enasidenib use by either parent may cause birth defects.

Keep using birth control for at least 1 month after your last dose of enasidenib. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because enasidenib may harm the baby if a pregnancy does occur.

It is not known whether enasidenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 1 month after your last dose.

How should I take enasidenib?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Enasidenib is usually given once per day. Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking enasidenib.

You may take enasidenib with or without food.

Do not crush, chew, or break an enasidenib tablet. Swallow it whole.

Enasidenib is usually given until your body no longer responds to the medication.

If you vomit shortly after taking enasidenib, take another dose as soon as possible. Then take your next dose at the regularly scheduled time.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the canister of moisture-absorbing preservative.

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 enasidenib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of enasidenib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Enasidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking enasidenib.

Seek medical help right away if you have symptoms of differentiation syndrome:

  • fever, cough, trouble breathing;
  • bone pain;
  • rapid weight gain; or
  • swelling in your arms, legs, underarms, groin, or neck.

Call your doctor at once if you have any of these side effects:

  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe or ongoing vomiting or diarrhea; or
  • signs of tumor cell breakdown --vomiting, diarrhea; little or no urination; numbness or tingly feeling; muscle weakness or twitching; fast or slow heart rate; confusion, hallucinations, seizure, feeling restless or irritable.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite; or
  • jaundice.

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.

What other drugs will affect enasidenib?

Other drugs may interact with enasidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about enasidenib.

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.

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