Idhifa 100 mg tablet

Generic name:
Enasidenib - oral

Pronunciation
(EN-a-SID-a-nib)

Brand name(s)
Idhifa

Enasidenib has rarely caused a serious (possibly fatal) condition called differentiation syndrome. This condition may happen anytime during the first 5 months of treatment. Get medical help right away if you develop any signs of differentiation syndrome, such as fever, cough, shortness of breath, trouble breathing, bone pain, rapid weight gain, swelling of arms/legs, swelling around the neck/underarm/groin areas (swollen lymph nodes), dizziness/lightheadedness, fast heartbeat, or chest pain.

This medication is used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Enasidenib works by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

This drug has been withdrawn from the Canadian market due to problems with effectiveness.

Read the Medication Guide provided by your pharmacist before you start taking enasidenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush or split the tablets.

Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If you vomit after taking a dose, take another dose as soon as possible on the same day. Then take your next dose at the regular time the next day. Do not double the dose to catch up.

See also Warning section.

Diarrhea, nausea, vomiting, change in taste, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Enasidenib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• muscle spasms/weakness

Get medical help right away if you have any very serious side effects, including:

• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• yellowing eyes/skin

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking enasidenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using enasidenib. Enasidenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 2 months after the last dose. Women should also ask about using reliable backup birth control methods (such as condoms, diaphragm with spermicide) if they are using hormonal birth control (such as birth control pills). If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include fezolinetant, tizanidine, vorasidenib, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab tests (such as complete blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.