Idhifa Side Effects
Generic name: enasidenib
Medically reviewed by Drugs.com. Last updated on Jan 12, 2025.
Note: This document provides detailed information about Idhifa Side Effects associated with enasidenib. Some dosage forms listed on this page may not apply specifically to the brand name Idhifa.
Applies to enasidenib: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
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.
Precautions
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.
Serious side effects of Idhifa
Along with its needed effects, enasidenib (the active ingredient contained in Idhifa) 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 while taking enasidenib:
More common side effects
- 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
Other side effects of Idhifa
Some side effects of enasidenib 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:
For healthcare professionals
Applies to enasidenib: oral tablet.
General adverse events
The most common (30% or more) adverse reactions of any grade were elevated bilirubin, decreased calcium and potassium levels, nausea, diarrhea, vomiting, and decreased appetite.[Ref]
Hepatic
- Very common (10% or more): Increased total bilirubin (81%)[Ref]
Metabolic
- Very common (10% or more): Decreased calcium (74%), decreased potassium (41%), decreased appetite (34%), decreased phosphorus (27%)
- Common (1% to 10%): Tumor lysis syndrome, decreased weight[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (50%), diarrhea (43%), vomiting (34%)
- Common (1% to 10%): Abdominal pain[Ref]
Hematologic
- Very common (10% or more): Differentiation syndrome (14%), noninfectious leukocytosis (12%)[Ref]
Nervous system
- Very common (10% or more): Dysgeusia (12%)[Ref]
Dermatologic
Genitourinary
- Common (1% to 10%): Increased uric acid[Ref]
Other
Renal
- Common (1% to 10%): Renal insufficiency[Ref]
Respiratory
- Common (1% to 10%): Respiratory failure, dyspnea, hypoxia, pulmonary edema, acute respiratory distress syndrome[Ref]
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References
1. (2017) "Product Information. Idhifa (enasidenib)." Celgene Corporation
Frequently asked questions
- How long does it take for Idhifa to start working?
- How does Idhifa work in acute myeloid leukemia (AML)?
- Can Idhifa cause differentiation syndrome?
- What is Idhifa used to treat?
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Further information
Idhifa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.
