Generic Name: enasidenib
Trade Name: IDHIFA®
For which conditions is this drug approved? IDHIFA is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. The labeling contains a boxed warning to alert healthcare professionals and patient about potential severe and/or life-threatening side effects of differentiation syndrome which affects your blood cells.
What is the mechanism of action? IDHIFA is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, IDHIFA is an inhibitor of the PI3K kinase, which is expressed in normal and malignant B-cells.
How is IDHIFA typically given (administered)? IDHIFA is taken orally, once per day at the same time each day. IDHIFA should be swallowed whole (do not chew or split) with 8 ounces of water, with or without food. If you miss a dose or vomit immediately after you have taken IDHIFA, take the dose of IDHIFA as soon as possible on the same day and take your next dose the next day at your regularly scheduled time. However, do not take two doses at the same time to make up for a missed dose.
How are patients typically monitored? During treatment with IDHIFA, at a minimum your healthcare provider will do blood tests to check your blood counts before you start treatment and at least every two weeks for the first 3 months during treatment to check for side effects. IDHIFA can harm an unborn baby, so women and partners of men taking this drug should not become pregnant for at least 1 month following treatment. Do not breastfeed during treatment with IDHIFA and for at least 1 month after the last dose of IDHIFA.
What are the common (occur in 20% or more of patients) side effects of treatment with IDHIFA?
- Decreased appetite
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IDHIFA and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
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Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions, particularly if you have an infection, lung or breathing problems, high blood pressure, and/or diabetes or high blood sugar. Women who are able to become pregnant should use effective birth control during treatment with IDHIFA and for one month after stopping treatment. Avoid grapefruit and grapefruit products during treatment with IDHIFA and avoid taking St. John’s Wort. If you are of childbearing age, talk to your doctor about the appropriate contraceptive for you or your partner during treatment with IDHIFA as hormonal contraceptives may not work as well while on IDHIFA.
When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your doctor right away if you have signs or symptoms of infection, high blood sugar, high blood pressure, lung or breathing problems, and/or severe skin reactions. IDHIFA may cause severe or life-threatening side effects from differentiation syndrome and it is important that you call your healthcare provider or seek care from the nearest emergency room right away if you experience any of the following symptoms:
- Shortness of breath
- Swelling of arms and legs
- Swelling around neck, grown or underarm area
- Fast weight gain (more than 10 pounds in a week)
- Bone Pain
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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