Description
Ziftomenib is used to treat acute myeloid leukemia with nucleophosmin 1 (NPM1) mutation in patients whose disease has come back or did not respond to previous treatment, and have no other satisfactory treatment options. Your doctor will perform a test before you take this medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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 ziftomenib 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 ziftomenib 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart failure or
- Heart rhythm problems (eg, long QT syndrome)—Use with caution. May make these conditions worse.
- Hypokalemia (low potassium levels in the blood) or
- Hypomagnesemia (low magnesium levels in the blood)—Must be corrected first before using this medicine.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine at the same time each day. Take this medicine on an empty stomach (1 hour before or 2 hours after a meal).
Swallow the capsule whole. Do not open, break, or chew it.
Take this medicine at least 2 hours before or 2 hours after taking an antacid (eg, calcium carbonate) and 2 hours before or 10 hours after taking an H2 blocker.
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 (capsules):
- For treatment of acute myeloid leukemia:
- Adults—600 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of acute myeloid leukemia:
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 and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 6 months after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant, tell your doctor right away.
Using this medicine may cause differentiation syndrome, which may be life-threatening. It may occur within 3 days and up to 46 days after treatment with this medicine. Check with your doctor right away if you have agitation, bloating or swelling of the face, arms, hands, lower legs, or feet, blurred vision, coma, confusion, decreased urine output, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, sweating, tingling of the hands or feet, trouble breathing, or unusual weight gain or loss. Your doctor may give you a steroid medicine (eg, dexamethasone) to help treat these symptoms.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have a heart rhythm problem, including QT prolongation.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
- Arm or leg pain
- black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody urine
- blurred vision
- bone pain
- chest pain or tightness
- collection of blood under the skin
- confusion
- cough or hoarseness
- coughing up blood
- decreased amount of urine
- deep, dark purple bruise
- diarrhea
- difficulty in breathing or swallowing
- dizziness
- fainting
- fever or chills
- frequent urge to urinate
- headache
- increase blood pressure
- increased menstrual flow or vaginal bleeding
- irregular heartbeat, recurrent
- itching, pain, redness, or swelling
- joint pain
- lower back or side pain
- muscle or body aches
- nausea or vomiting
- neck pain
- nervousness
- nosebleeds
- painful blisters on trunk of the body
- painful or difficult urination
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- rapid weight gain
- slow or fast heartbeat
- sneezing
- stuffy or runny nose
- swelling of the face, fingers, or lower legs
- tingling of the hands or feet
- unusual weight gain or loss
- vomiting of blood or material that looks like coffee grounds
- weight gain
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-80008539
