Description
Ivosidenib is used alone or together with azacitidine to treat newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years of age or older or who have health problems that prevent the use of certain cancer treatments (chemotherapy). It is also used to treat AML that has come back or has not improved after a previous treatment. Ivosidenib is also used to treat cholangiocarcinoma (bile duct cancer) that has spread or cannot be removed by surgery in patients who have already received a previous treatment. Ivosidenib is also used to treat myelodysplastic syndromes (MDS) that has come back or has not improved after a previous treatment. It is used only in patients who have an isocitrate dehydrogenase-1 (IDH1) mutation in their AML, cholangiocarcinoma, or MDS. Your doctor will test for the presence of this mutation.
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 ivosidenib 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 ivosidenib 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.
- Atazanavir
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Isavuconazonium Sulfate
- Ketoconazole
- Lonafarnib
- Lorlatinib
- Mavacamten
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Praziquantel
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Adagrasib
- Alfentanil
- Alfuzosin
- Alpelisib
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Astemizole
- Avacopan
- Avanafil
- Azithromycin
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Boceprevir
- Bosutinib
- Budesonide
- Buprenorphine
- Buserelin
- Buspirone
- Capivasertib
- Carbamazepine
- Celecoxib
- Ceritinib
- Chloroquine
- Chlorpromazine
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.
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:
- Electrolyte imbalance or
- Guillain-Barré syndrome (autoimmune disease) or
- Heart failure or
- Heart rhythm problems (eg, long QT syndrome) or—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe—Use has not been studied in patients with these conditions.
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.
You may take this medicine with or without food. However, do not take this medicine with a high fat meal.
Swallow the tablet whole. Do not crush, break, or chew it.
Drink plenty of fluids to help prevent other unwanted effects.
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 newly diagnosed acute myeloid leukemia (in combination with azacitidine):
- Adults—500 milligrams (mg) taken once a day. Start treatment on Cycle 1 Day 1 in combination with azacitidine injected under the skin or into a vein once a day on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28 day cycle. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For newly diagnosed, relapsed, or refractory acute myeloid leukemia, cholangiocarcinoma (taken alone), and myelodysplastic syndromes:
- Adults—500 milligrams (mg) taken once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For newly diagnosed acute myeloid leukemia (in combination with azacitidine):
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 less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. 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. Do not administer 2 doses within 12 hours.
If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual 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 may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur within 1 day and up to 3 months after treatment with this medicine. Check with your doctor right away if you start to have a fever, cough, trouble breathing, swelling of the arms or legs or around the neck, groin, or underarms, rapid weight gain, or bone pain.
This medicine may also cause a serious reaction called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.
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 had a heart rhythm problem, including QT prolongation.
Contact your doctor immediately if fever, rash, joint pain, sudden numbness and weakness in the arms and legs, or inability to move the arms and legs occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.
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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- chest pain or tightness
- chills
- confusion
- cough
- decreased urination
- difficult or labored breathing
- difficulty in moving
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- fainting
- fever
- general feeling of illness
- headache
- irregular heartbeat, recurrent
- joint pain, stiffness, or swelling
- lower back, side, or stomach pain
- muscle ache, cramps, pain, or stiffness
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- rash
- sensation of pins and needles
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stabbing pain
- swelling of your arms, feet, or lower legs
- unusual bleeding or bruising
- unusual tiredness or weakness
Rare
- Inability to move the arms and legs
- sudden numbness and weakness in the arms and legs
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
- Cracked lips
- decreased appetite
- diarrhea
- difficulty in swallowing
- nausea
- 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.
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