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Care During Chemotherapy and Beyond

Enasidenib

(en a SID a nib)

Trade Name: Idhifa®

Enasidenib is the generic name for the trade name drug Idhifa. In some cases, health care professionals may use the trade name Idhifa when referring to the generic drug name enasidenib.

Drug Type: Enasidenib is an anti-cancer ("antineoplastic") chemotherapy drug. This medicine is classified as an "isocitrate dehydrogenase 2 (IDH2) inhibitor." (For more detail see "How Enasidenib Works" section below).

What Enasidenib Is Used For

  • Relapsed or refractory acute myeloid leukemia (AML) that is IDH2 mutated or changed

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Enasidenib Is Given

  • This drug is administered orally once daily with or without food at approximately the same time each day.
  • Swallow tablets whole with a full glass of water. Do not split or crush the tablets.
  • If a dose is missed, vomited, or delayed, administer the dose as soon as you remember on the same day. If you do not think about the missed dose until the next day, skip the missed dose and continue with the next scheduled dose. Do not take two doses on the same day.

The usual dosing is 100mg once daily. The dose may be reduced depending on your general health or other health problems. Your doctor will determine your exact dosage and schedule.

Side Effects

Important things to remember about the side effects of enasidenib:

  • Most people will not experience all of the enasidenib side effects listed.
  • Enasidenib side effects are often predictable in terms of their onset, duration, and severity.
  • Enasidenib side effects will improve after therapy is complete.
  • Enasidenib side effects may be quite manageable. There are many options to minimize or prevent the side effects of enasidenib.

The following side effects are common (occurring in greater than 30%) for patients taking enasidenib:

These are less common side effects (occurring in 10-29%) for patients receiving enasidenib:

  • Taste changes
  • Cytokine release syndrome. This is a profound inflammatory response that can happen in your body.
  • Leukocytosis. Your white blood cell count may temporarily increase.

An uncommon, but serious, side effect of enasidenib is differentiation syndrome. This is a condition that affects your blood cells which may be a life threatening or lead to death if not treated. This can occur in as early as 10 days and during the first 5 months of treatment. Call your doctor to go to the nearest emergency room if you develop any of the following symptoms:

  • Fever
  • Cough
  • Shortness of breath
  • Swelling of the arms and legs
  • Swelling around neck, groin, or underarm area
  • Fast weight gain (greater than 10 pounds within a week)
  • Bone pain

Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10% of patients - are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When To Contact Your Doctor or Health Care Provider:

Contact your healthcare provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4° F (38° C) or higher, chills (possible signs of infection), bone pain, cough, difficulty breathing, swelling of arms and legs.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medications)
  • Vomiting (vomiting more than 4-5 times in a 24-hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Pain or burning with urination
  • Extreme fatigue (unable to carry on self-care activities)
  • Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting enasidenib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, or herbal remedies, etc.).
  • Do not receive any kind of immunization or vaccination without your doctor's approval while taking enasidenib.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. The use of enasidenib in pregnancy may cause fetal harm.
  • For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking enasidenib.
  • Do not breast feed while taking enasidenib.

Self-Care Tips

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often.
  • To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
  • Use an electric razor and a soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
  • Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
  • Eat foods that may help reduce diarrhea.
  • Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
  • Avoid people with any type of infection or who recently have been vaccinated.

Monitorig and Testing While Taking Enasidenib

You will be checked regularly by your doctor while you are taking enasidenib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver).

How Enasidenib Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different type of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Enasidenib is a targeted therapy that inhibits a protein that helps cells grow called isocitrate dehyrdogenase 2 (IDH2). This protein can be mutated or changed in some patients. Enasidenib targets the mutated forms of IDH2 more selectively than the normal forms of the protein.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

References

  • Enasidenib [package insert]. Summit, NJ: Celgene Corporation; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf. Accessed September 20, 2017.
  • Enasidenib. Lexicomp Online. Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc.; August 1, 2017.

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