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Tibsovo
ivosidenib
Black Box Warnings .
Differentiation Syndrome in AML and Myelodysplastic Syndrome
occurred as early as 1 day and up to 3mo after tx start; may be life-threatening or fatal; if suspected, initiate corticosteroids and hemodynamic monitoring until symptom resolution; initiate hydroxyurea or leukapheresis as clinically indicated if concomitant noninfectious leukocytosis; taper corticosteroids and hydroxyurea after symptom resolution; administer corticosteroids for at least 3 days; if severe signs/symptoms persists >48h after starting corticosteroids, hold tx until signs/symptoms no longer severe; signs/symptoms include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction
Adult Dosing .
Dosage forms: TAB: 250 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
IDH1-mutated AML
- [newly diagnosed disease]
- Dose: 500 mg PO qd for at least 6mo; Info: for patients 75 yo and older, or who are ineligible for intensive induction chemo due to comorbidities; use with azacitidine or as monotherapy; do not cut/crush/chew tab; avoid administration with high fat meal
- [relapsed or refractory disease]
- Dose: 500 mg PO qd for at least 6mo; Info: do not cut/crush/chew tab; avoid administration with high fat meal
IDH1-mutated myelodysplastic syndrome, relapsed or refractory
- [500 mg PO qd for at least 6mo]
- Info: do not cut/crush/chew tab; avoid administration with high fat meal
IDH1-mutated cholangiocarcinoma, locally advanced or metastatic
- [500 mg PO qd]
- Info: for patients with previously treated disease; do not cut/crush/chew tab; avoid administration with high fat meal
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- baseline QTc >450 msec
- long QT syndrome, congenital
- avoid: breastfeeding during tx and x1mo after D/C
- caution: patients of childbearing potential
- caution: electrolyte abnormalities
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
ivosidenib
IDH1 inhibitor
- CYP3A4 substrate
- P-gp substrate
- CYP2C8 inducer, weak
- CYP2C9 inducer, weak
- CYP3A4 inducer, strong
- myelosuppressive oncologic agent
- prolongs QT interval (known)
Contraindicated
- artemether/lumefantrine
- atazanavir
- cisapride
- domperidone
- doravirine
- dronedarone
- elbasvir
- fostemsavir
- grazoprevir
- isavuconazonium
- lenacapavir
- levoketoconazole
- lonafarnib
- lorlatinib
- lurasidone
- mavacamten
- nirmatrelvir
- pacritinib
- pimozide
- posaconazole
- praziquantel
- ranolazine
- thioridazine
- tipranavir
- zoliflodacin
Avoid/Use Alternative
- abemaciclib
- abiraterone acetate
- acalabrutinib
- acoramidis
- adagrasib
- alfentanil
- alpelisib
- amiodarone
- anagrelide
- apalutamide
- apixaban
- apomorphine
- apremilast
- aprepitant
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- arsenic trioxide
- asenapine
- atogepant
- atrasentan
- avacopan
- avanafil
- avapritinib
- axitinib
- azithromycin
- bedaquiline
- berotralstat
- bictegravir
- bortezomib
- bosentan
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- butalbital
- cabozantinib
- capivasertib
- capmatinib
- carbamazepine
- cariprazine
- cenobamate
- ceritinib
- chloramphenicol
- chloroquine
- ciprofloxacin
- citalopram
- cladribine oral
- clarithromycin
- clofazimine
- clozapine
- cobicistat
- cobimetinib
- codeine
- conivaptan
- copanlisib
- crizotinib
- cyclosporine
- dabrafenib
- danazol
- daridorexant
- darolutamide
- darunavir
- dasatinib
- defactinib
- deferiprone
- deflazacort
- degarelix
- desflurane
- desipramine
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexrazoxane
- diazoxide
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- disopyramide
- dofetilide
- dolutegravir
- donepezil
- dordaviprone
- doxorubicin
- droperidol
- drospirenone (contraceptive)
- duvelisib
- efavirenz
- elacestrant
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elinzanetant
- elvitegravir
- encorafenib
- ensartinib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- erdafitinib
- eribulin
- erlotinib
- erythromycin
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etoposide
- etrasimod
- etravirine
- everolimus
- fedratinib
- felodipine
- fenfluramine
- fentanyl
- fexinidazole
- finerenone
- flecainide
- flibanserin
- fluconazole
- fluorouracil
- fluoxetine
- fosamprenavir
- fosaprepitant
- foscarnet
- fosfomycin injection
- fosphenytoin
- fostamatinib
- fruquintinib
- futibatinib
- ganaxolone
- ganciclovir
- gepirone
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- glecaprevir
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibrexafungerp
- ibrutinib
- ibutilide
- idelalisib
- iloperidone
- imatinib
- imlunestrant
- inotuzumab ozogamicin
- irinotecan
- isoflurane
- isradipine
- istradefylline
- itraconazole
- ivabradine
- ivacaftor
- ixabepilone
- ixazomib
- ketoconazole
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- lemborexant
- leniolisib
- letermovir
- leuprolide
- levofloxacin
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- linagliptin
- lofexidine
- loperamide
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- lumateperone
- lurbinectedin
- macimorelin
- macitentan
- maraviroc
- maribavir
- mavorixafor
- medroxyprogesterone (contraceptive)
- meperidine
- methadone
- midazolam
- midostaurin
- mifepristone
- milsaperidone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- moxifloxacin
- nafcillin
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- nerandomilast
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- nintedanib
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- ondansetron
- orforglipron
- osimertinib
- oxaliplatin
- oxycodone
- ozanimod
- palbociclib
- palifermin
- paliperidone
- palonosetron
- palovarotene
- pasireotide
- pazopanib
- pemigatinib
- penicillamine
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pirtobrutinib
- pitolisant
- ponatinib
- ponesimod
- pralsetinib
- pretomanid
- primaquine
- primidone
- procainamide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- radium Ra 223 dichloride
- regorafenib
- relugolix
- remibrutinib
- repotrectinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- rilzabrutinib
- rimegepant
- ripretinib
- ritlecitinib
- ritonavir
- rivaroxaban
- roflumilast
- rolapitant
- romidepsin
- ropeginterferon alfa-2b
- rucaparib
- samidorphan
- sebetralstat
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sertraline
- sevabertinib
- sevoflurane
- simvastatin
- siponimod
- sirolimus
- sirolimus albumin-bound
- solifenacin
- sonidegib
- sorafenib
- sotalol
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- sufentanil
- sunitinib
- sunvozertinib
- suzetrigine
- tadalafil
- taletrectinib
- tamoxifen
- tasimelteon
- tazemetostat
- telavancin
- temsirolimus
- tetrabenazine
- tezacaftor/ivacaftor
- thiotepa
- ticagrelor
- tivozanib
- tofacitinib
- tolvaptan
- toremifene
- trabectedin
- tramadol
- trazodone
- tretinoin
- triazolam
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- ubrogepant
- ulipristal (post-coital contraceptive)
- upadacitinib
- valbenazine
- valganciclovir
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- vorapaxar
- voriconazole
- voxilaprevir
- zaleplon
- zanubrutinib
- ziftomenib
- ziprasidone
- zolpidem
- zongertinib
- zuranolone
Monitor/Modify Tx
- aficamten
- albendazole
- albuterol
- albuterol inhaled
- alemtuzumab
- alfuzosin
- allopurinol
- alprazolam
- aminophylline
- amisulpride
- amitriptyline
- amlodipine
- anti-thymocyte globulin
- arformoterol inhaled
- asciminib
- atidarsagene autotemcel
- atorvastatin
- auranofin
- avatrombopag
- azathioprine
- balsalazide
- baricitinib
- belumosudil
- benznidazole
- berberine
- betamethasone
- betibeglogene autotemcel
- bicalutamide
- brexpiprazole
- butorphanol
- calcitriol
- cannabidiol
- chlorpromazine
- chlorzoxazone
- cholecalciferol (vitamin D3)
- cidofovir
- cilostazol
- cimetidine
- clobazam
- clomipramine
- clotrimazole oropharyngeal
- colchicine
- copper histidinate
- cortisone
- cranberry
- crinecerfont
- cyclophosphamide
- dapsone
- deferasirox
- deutetrabenazine
- diosmin
- doxercalciferol
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- eravacycline
- escitalopram
- ethosuximide
- etuvetidigene autotemcel
- exagamglogene autotemcel
- exemestane
- filgrastim (G-CSF)
- fingolimod
- flucytosine
- fludrocortisone
- fluphenazine
- fluvoxamine
- formoterol inhaled
- gefitinib
- gemtuzumab ozogamicin
- ginkgo
- givosiran
- goldenseal
- granisetron
- guanfacine
- hydrocortisone
- hydroxyurea
- ifosfamide
- imipramine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoniazid
- kratom
- leflunomide
- lenvatinib
- levalbuterol inhaled
- linezolid
- lomitapide
- lovastatin
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- mefloquine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methylprednisolone
- metronidazole
- mirtazapine
- mycophenolate mofetil
- mycophenolic acid
- nortriptyline
- ofloxacin
- olodaterol inhaled
- olsalazine
- osilodrostat
- oxcarbazepine
- paltusotine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- peppermint
- perampanel
- pibrentasvir
- prednisolone
- prednisone
- proguanil
- promethazine
- pyrimethamine
- quercetin
- remdesivir
- repaglinide
- resveratrol
- ribavirin
- risperidone
- rituximab
- ruxolitinib topical
- sacituzumab govitecan
- salmeterol inhaled
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- seladelpar
- sildenafil
- spironolactone
- succimer
- sulfasalazine
- tacrolimus
- teplizumab
- terbutaline
- teriflunomide
- thalidomide
- theophylline
- tiagabine
- tocilizumab
- tolterodine
- treosulfan
- triamcinolone
- trimethoprim
- trofinetide
- valproic acid
- vancomycin
- vardenafil
- venlafaxine
- vilanterol inhaled
- vilazodone
- viloxazine
- vimseltinib
- vortioxetine
- warfarin
- xanomeline
- zidovudine
- zileuton
- zonisamide
Caution Advised
- aliskiren
- armodafinil
- brentuximab vedotin
- bromocriptine
- budesonide
- cannabis
- clindamycin
- clonazepam
- diazepam
- dronabinol
- drospirenone (hormone replacement)
- elagolix
- enfortumab vedotin
- eplerenone
- esomeprazole
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- eszopiclone
- ethinyl estradiol (hormone replacement)
- felbamate
- fesoterodine
- finasteride
- glyburide
- isotretinoin
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- medroxyprogesterone (hormone replacement)
- methylergonovine
- metoclopramide
- montelukast
- norethindrone (hormone replacement)
- olanzapine
- omeprazole
- ospemifene
- paclitaxel
- paroxetine
- polatuzumab vedotin
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- ramelteon
- red yeast rice
- riociguat
- ruxolitinib
- selegiline
- suvorexant
- telisotuzumab vedotin
- terbinafine
- tinidazole
- tisotumab vedotin
- topiramate
Adverse Reactions .
Serious Reactions
- differentiation syndrome
- leukocytosis
- neutropenia
- thrombocytopenia
- tumor lysis syndrome
- QT prolongation
- ventricular arrhythmia
- Guillain-Barre syndrome
- PML
- posterior reversible encephalopathy syndrome
- cerebral ischemia
- pulmonary embolism
- HTN
- pneumonia
- ascites (cholangiocarcinoma use)
Common Reactions
- fatigue
- diarrhea
- nausea
- abdominal pain
- leukocytosis
- cough
- arthralgia
- appetite decr.
- edema
- rash
- dyspnea
- vomiting
- QT prolongation
- mucositis
- headache
- constipation
- fever
- differentiation syndrome
- myalgia
- chest pain
- ascites
- neuropathy
- pleural effusion
- anemia
- hypotension
- tumor lysis syndrome
- pruritus
- HTN
- sodium decr.
- magnesium decr.
- potassium decr.
- bilirubin incr.
- Cr incr.
- albumin decr.
- phosphate decr.
- ALT or AST incr.
Safety/Monitoring .
Monitoring Parameters
AML or Myelodysplastic Syndrome: CBC with diff, chemistry profile at baseline, then at least qwk during 1st mo, then q2wk x1mo, then qmo during tx; ECG at baseline, then at least qwk during 1st 3wk, then at least qmo during tx or more frequently if QT prolongation risk; CK qwk during 1st mo; signs/symptoms of neuropathy
Cholangiocarcinoma: ECG at baseline, then at least qwk during 1st 3wk, then at least qmo during tx or more frequently if QT prolongation risk; signs/symptoms of neuropathy
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of skeletal variations and decr. fetal wt based on animal data at 2x systemic exposure
Individuals of Reproductive Potential
avoid pregnancy by using effective non-hormonal contraception during tx in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x1mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for ivosidenib: liver primarily; CYP450: 3A4 substrate
Excretion: for ivosidenib: feces 77% (67% unchanged), urine 17% (10% unchanged); Half-life: 58-129h
Subclass: Epigenetic Modifiers, Isocitrate Dehydrogenase (IDH) Inhibitors
Mechanism of Action
for ivosidenib: inhibits mutant isocitrate dehydrogenase 1 (IDH1) enzyme, leading to decr. 2-hydroxyglutarate (2-HG) levels and induced myeloid differentiation
Formulary .
No Formulary Selected
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