Pronunciation:

en-a-SID-a-nib

Brand Names:

• Idhifa

Dosage Forms:

• Tablet

Warnings:

Patients treated with enasidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution .Early recognition and aggressive management of differentiation syndrome is required to lessen the likelihood of serious illness and death. Symptoms of differentiation syndrome should be described to patients when starting therapy and at follow-up visits. Differentiation syndrome has occurred as early as 10 days and up to 5 months after initiating therapy .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Enasidenib is used to treat acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation in patients who have not responded to other treatments or to those whose cancer has come back after treatment.

Enasidenib is an isocitrate dehydrogenase-2 inhibitor. It works by blocking the enzyme isocitrate dehydrogenase which is needed by the cancer cells to grow.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of enasidenib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enasidenib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Bosentan
• Digoxin
• Elagolix
• Glyburide
• Grazoprevir
• Irinotecan
• Letermovir
• Methotrexate
• Ozanimod
• Pitavastatin
• Pravastatin
• Repaglinide
• Revefenacin
• Rosuvastatin
• Simvastatin
• Sulfasalazine
• Tenofovir Alafenamide
• Topotecan
• Ubrogepant

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with 1 cup (8 ounces) of water. Do not crush, break, or chew it.

Take this medicine at the same time each day. You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of acute myeloid leukemia (AML):
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or vomit after taking a dose of this medicine, take the missed dose as soon as possible on the same day, and then go back to your regular dosing schedule. Do not take 2 doses at the same time to make up for a missed dose.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store this medicine in its original container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects at least every 2 weeks for the first 3 months during treatment with this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. Women should use an effective form of birth control during treatment and for at least 2 months after the last dose. Men should use an effective form of birth control during treatment and for at least 2 months after the last dose to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur within 10 days and during the first 5 months of treatment with this medicine. Check with your doctor right away if you start to have a fever, cough, shortness of breath, swelling of the arms or legs or around the neck, groin, or underarms, rapid weight gain, or bone pain.

This medicine may increase risk of a serious condition called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

blue lips, fingernails, or skin

bone pain

chest pain

chills

confusion

cough

coughing that sometimes produces a pink frothy sputum

decreased awareness or responsiveness

decreased urine output

depression

difficult or troubled breathing

difficult, fast, noisy breathing

dizziness

eye pain

fainting

fast heartbeat

fever

general feeling of illness

headache

hostility

increased sweating

irregular, fast or slow, or shallow breathing

irritability

lightheadedness

loss of consciousness

muscle or joint pain

muscle twitching

nausea

pale skin

rapid weight gain

rapid, shallow breathing

seizures

severe sleepiness

sore throat

swelling around the neck, groin, or underarm area

swelling of the arms, feet, or lower legs

swelling of the face, ankles, or hands

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

yellow skin or eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste

decreased appetite

diarrhea

loss of taste

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.