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Enasidenib

Generic name: enasidenib [ EN-aSID-aNib] 

Name of the brand: Idhifa
Dosage format: oral tablet (100 mg, 50 mg)
Classification of drugs: Miscellaneous antineoplastics

What is Enasidenib?

Enasidenib is a treatment for acute myeloid leukemia (AML) in adult patients with the IDH2 mutation. Enasidenib is prescribed when AML has returned or is not improving with prior treatments.Enasidenib can also be used for reasons not mentioned in this guideline.

Side effects of Enasidenib

Contact a medical professional immediately. If you are experiencing symptoms that are warning signs of an allergic response, such as difficulty breathing, hives, or swelling of your lips, face, and throat,Enasidenib could cause a condition known as differentiation syndrome. This condition affects blood cells and can cause death if not treated. The condition can manifest between 10 and five months after beginning to take enasidenib.Get medical attention immediately if you exhibit the following symptoms:

  • The fever, cough, and trouble breathing
  • Bone pain;
  • Rapid weight gain
  • Swelling in your legs, arms, or underarms. It can also affect your groin or neck.

Contact your doctor immediately.If any of these symptoms arise:

  • Dark urine, stools that are colored with clay, jaundice (yellowing of the eyes or skin);
  • Persistent or severe nausea as well as diarrhea and
  • Signs of tumor cell breakdown include fatigue, weakness, muscle cramps, nausea, vomiting and diarrhea as well as fast or slow heart rates as well as tingling in your hands, feet or around your mouth.

Common adverse effects of enasidenib could include:

  • Nausea, vomiting, diarrhea;
  • Lack of appetite

This isn't an exhaustive list of possible side effects, and other side effects could occur. Contact your doctor to seek medical advice on adverse effects. You can report any symptoms to the FDA at 1-800-FDA-1088.

Similar/related drugs

venetoclax, Venclexta, azacitidine, vincristine, cytarabine, and ivosidenib

Warnings

Take immediate medical advice. If you experience indications of differentiation syndrome between 10 days and five months after you have taken enasidenib, It is characterized by cough, fever, trouble breathing, bone pain, fast weight gain, or swelling of your legs, arms, groin, or neck.

Before you take this drug

You might need to undergo an unfavorable pregnancy test prior to commencing this treatment.Men and women who use the drug enasidenib are advised to take birth control to stop the pregnancy. Enasidenib could cause harm to an unborn baby in the case that the father or mother is taking this medication.Use birth control for at least two months following the last dose. Inform your doctor immediately when you become pregnant.Don't breastfeed during the course of this medication and for a minimum of 2 months following your last dose.

How to take Enasidenib?

Follow the directions on the prescription label and read the medication guide or instructions sheets. Follow the medication exactly as prescribed.Drink plenty of fluids when you take enasidenib.You can take it either with or without food at the same time every day.Don't crush, chew, or break the tablet. Take it in its entirety.If you experience vomiting shortly after taking enasidenib, do not take a second dose. Your next dose should be taken on time.You might require regular medical tests, and your cancer treatment may be delayed depending on the results.Keep the tablets at room temperature, far from heat and moisture. Place the tablets in the original container together with the canister of a preservative that absorbs moisture.

Details on dosage

Usual Adult Dose for Acute Myeloid Leukemia:

100 mg orally, once a day, whether or not food
Duration of therapy:
Treat until the disease has progressed or is unacceptably toxic.
If a patient is not experiencing progression of the disease or unacceptable toxicities, the treatment should last for a minimum of six months to allow for a clinical response.
Comments: Select patients based on the presence of isocitrate dehydrogenase-2 (IDH2) mutations in the blood or bone marrow as detected by an FDA-approved test, http://www.fda.gov/CompanionDiagnostics.
Use: Treatment for chronic or refractory acute myeloid leukemia (AML) that has the IDH2 mutation.

What happens if I miss the dose?

You can take the dose you missed on the day you remember it. Next dose taken at the same time, and adhere to your daily schedule. Avoid taking two doses at once in a day.

What happens if I overdose?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

Follow the instructions of your physician regarding any limitations on foods, drinks, or activities.

Interaction with other drug

Other drugs can interact with enasidenib's effects, such as prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your physician all the medications you currently use and any medication you begin or stop taking.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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