Ivosidenib (Oral route)

Pronunciation:

eye-voe-SID-e-nib

Brand Names:

Tibsovo

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Warning: Differentiation SyndromePatients treated with ivosidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution .Early recognition and aggressive management of differentiation syndrome is required to lessen the likelihood of serious illness and death. Symptoms of differentiation syndrome should be described to patients when starting therapy and at follow-up visits. Differentiation syndrome has occurred as early as 10 days and up to 5 months after initiating therapy with another isocitrate dehydrogenase 2 inhibitor .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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. It is used only in patients who have an isocitrate dehydrogenase-1 (IDH1) mutation in their AML or cholangiocarcinoma. Your doctor will test for the presence of this mutation.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ivosidenib in the elderly.

Breast-feeding—

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.

Other medicines—

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.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Lorlatinib
Mavacamten
Mesoridazine
Pimozide
Piperaquine
Posaconazole
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
Acalabrutinib
Adagrasib
Alfentanil
Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Avanafil
Azithromycin
Bedaquiline
Boceprevir
Bosutinib
Budesonide
Buprenorphine
Buserelin
Buspirone
Carbamazepine
Celecoxib
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clothiapine
Clozapine
Cobicistat
Cobimetinib
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Darifenacin
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desogestrel
Deutetrabenazine
Dexmedetomidine
Dienogest
Diltiazem
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Drospirenone
Ebastine
Efavirenz
Eletriptan
Elexacaftor
Encorafenib
Entrectinib
Enzalutamide
Eplerenone
Eribulin
Erythromycin
Escitalopram
Estetrol
Estradiol
Ethinyl Estradiol
Ethynodiol
Etonogestrel
Everolimus
Famotidine
Fedratinib
Felbamate
Felodipine
Fexinidazole
Fingolimod
Flecainide
Fluoxetine
Fluticasone
Fluvoxamine
Formoterol
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fostemsavir
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Gestodene
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibrexafungerp
Ibrutinib
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indinavir
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivacaftor
Lapatinib
Lefamulin
Lenvatinib
Letermovir
Leuprolide
Levofloxacin
Levonorgestrel
Lofexidine
Lomitapide
Lopinavir
Lovastatin
Lumacaftor
Lumefantrine
Lurasidone
Lurbinectedin
Macimorelin
Maraviroc
Medroxyprogesterone
Mefloquine
Mestranol
Methadone
Methotrimeprazine
Metronidazole
Midazolam
Mifepristone
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Moricizine
Moxifloxacin
Nafarelin
Naloxegol
Nefazodone
Nelfinavir
Netupitant
Nilotinib
Nirmatrelvir
Nomegestrol
Norelgestromin
Norethindrone
Norfloxacin
Norgestimate
Norgestrel
Octreotide
Ofloxacin
Olanzapine
Omaveloxolone
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Ozanimod
Pacritinib
Paliperidone
Palovarotene
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pipamperone
Pitolisant
Ponesimod
Pralsetinib
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Ribociclib
Rifampin
Risperidone
Ritlecitinib
Ritonavir
Segesterone
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sildenafil
Simvastatin
Siponimod
Sirolimus
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Temsirolimus
Tetrabenazine
Tezacaftor
Ticagrelor
Tipranavir
Tocilizumab
Tolterodine
Tolvaptan
Toremifene
Trazodone
Triazolam
Triclabendazole
Trimipramine
Triptorelin
Ulipristal
Valbenazine
Vandetanib
Vardenafil
Vemurafenib
Venetoclax
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Vortioxetine
Warfarin
Zolpidem
Zotepine
Zuclopenthixol
Zuranolone

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 of This Medicine:

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.
  - Children—Use and dose must be determined by your doctor.
- For newly diagnosed, relapsed, or refractory acute myeloid leukemia and cholangiocarcinoma (taken alone):
  - Adults—500 milligrams (mg) taken once a day.
  - Children—Use and dose must be determined by your doctor.

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 11/16/2023

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