Description
Enasidenib is used to treat acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation in patients who have not responded to other treatments or to those whose cancer has come back after treatment.
Enasidenib is an isocitrate dehydrogenase-2 inhibitor. It works by blocking the enzyme isocitrate dehydrogenase which is needed by the cancer cells to grow.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of enasidenib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enasidenib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Agomelatine
- Bacillus of Calmette and Guerin Vaccine, Live
- Colchicine
- Dengue Tetravalent Vaccine, Live
- Elagolix
- Fezolinetant
- Grazoprevir
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Ranolazine
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Tizanidine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Acalabrutinib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Alpelisib
- Astemizole
- Atogepant
- Atrasentan
- Axitinib
- Bosutinib
- Brigatinib
- Cariprazine
- Ceritinib
- Cholera Vaccine
- Cisapride
- Clindamycin
- Cobimetinib
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabigatran Etexilate
- Dasatinib
- Desogestrel
- Diazoxide
- Dienogest
- Dihydroergotamine
- Docetaxel
- Dofetilide
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Ebola Zaire Vaccine, Live
- Eluxadoline
- Ensartinib
- Entrectinib
- Ergotamine
- Estetrol
- Estradiol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clopidogrel
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole with 1 cup (8 ounces) of water. Do not crush, break, or chew it.
Take this medicine at the same time each day. You may take this medicine with or without food.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of acute myeloid leukemia (AML):
- Adults—At first, 100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For treatment of acute myeloid leukemia (AML):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose or vomit after taking a dose of this medicine, take the missed dose as soon as possible on the same day, and then go back to your regular dosing schedule. Do not take 2 doses at the same time to make up for a missed dose.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store this medicine in its original container.
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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Women should use another form of birth control (eg, condoms, spermicide) along with your pills for 2 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 2 months after the last dose. 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.
Side Effects
Along with its needed effects, a medicine 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:
More common
- 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 trouble 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
Some side effects 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:
More common
- Change in taste
- decreased appetite
- diarrhea
- loss of taste
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20406484
