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Voranigo
vorasidenib
Adult Dosing .
Dosage forms: TAB: 10 mg, 40 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- or IDH2-positive astrocytoma, grade 2
- [40 mg PO qd]
- Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
IDH1- or IDH2-positive oligodendroglioma, grade 2
- [40 mg PO qd]
- Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >40: no adjustment; CrCl <40: 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 .
- Dosage forms: TAB: 10 mg, 40 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- or IDH2-positive astrocytoma, grade 2
- [12 yo and older, <40 kg]
- Dose: 20 mg PO qd; Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
- [12 yo and older, >40 kg]
- Dose: 40 mg PO qd; Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
IDH1- or IDH2-positive oligodendroglioma, grade 2
- [12 yo and older, <40 kg]
- Dose: 20 mg PO qd; Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
- [12 yo and older, >40 kg]
- Dose: 40 mg PO qd; Info: for patients with prior surgery including biopsy, sub-total resection, or gross total resection; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >40: no adjustment; CrCl <40: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x2mo after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: smoking habit change
Drug Interactions .
Overview
vorasidenib
IDH inhibitor
- CYP1A2 substrate
- CYP3A4 inducer, weak
Avoid/Use Alternative
- atazanavir
- caffeine
- caffeine citrate
- capmatinib
- ciprofloxacin
- codeine
- desogestrel (contraceptive)
- dienogest (contraceptive)
- dolutegravir
- drospirenone (contraceptive)
- enasidenib
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- fentanyl
- fexinidazole
- fluvoxamine
- fosamprenavir
- fosphenytoin
- givosiran
- leflunomide
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lumateperone
- mavacamten
- medroxyprogesterone (contraceptive)
- meperidine
- methoxsalen
- mexiletine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- oliceridine
- osilodrostat
- phenytoin
- ranolazine
- rifampin
- ritonavir
- rucaparib
- segesterone (contraceptive)
- St. John's wort
- teriflunomide
- ulipristal (post-coital contraceptive)
- vemurafenib
- viloxazine
- zuranolone
Monitor/Modify Tx
- aficamten
- amlodipine
- atogepant
- buprenorphine
- carbamazepine
- cyclophosphamide
- cyclosporine
- diltiazem
- disopyramide
- everolimus
- ifosfamide
- isradipine
- ketoconazole
- mitapivat
- nicardipine
- nimodipine
- nisoldipine
- oxycodone
- quinidine (antiarrhythmic)
- sirolimus
- tacrolimus
- tiagabine
- tramadol
- ubrogepant
- voriconazole
- warfarin
Caution Advised
- abemaciclib
- acalabrutinib
- acyclovir
- albendazole
- alfentanil
- allopurinol
- alprazolam
- amiodarone
- aprepitant
- artemether/lumefantrine
- atorvastatin
- avacopan
- avapritinib
- axitinib
- belumosudil
- bictegravir
- bosutinib
- brigatinib
- budesonide
- buspirone
- butalbital
- cabozantinib
- cannabidiol
- cannabis
- capivasertib
- cimetidine
- clarithromycin
- cobicistat
- cobimetinib
- crizotinib
- danshen
- daridorexant
- darunavir
- dasatinib
- defactinib
- deferasirox
- deflazacort
- diazoxide
- disulfiram
- doravirine
- dordaviprone
- dronedarone
- drospirenone (hormone replacement)
- echinacea
- efavirenz
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- entrectinib
- erdafitinib
- erlotinib
- ethanol (alcoholic beverage)
- ethanol injection
- ethinyl estradiol (hormone replacement)
- famotidine
- fedratinib
- felodipine
- finerenone
- fosaprepitant
- fostamatinib
- fruquintinib
- gepirone
- gilteritinib
- ginseng, Asian
- glasdegib
- glecaprevir
- grape
- grazoprevir
- guanfacine
- haloperidol
- hydrocortisone
- ibrutinib
- interferon beta 1a
- interferon beta 1b
- irinotecan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel intrauterine device (contraceptive)
- lonafarnib
- lorlatinib
- lurasidone
- macitentan
- maraviroc
- meropenem
- methadone
- midazolam
- midostaurin
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- obeticholic acid
- olaparib
- olutasidenib
- pacritinib
- palbociclib
- peginterferon alfa 2a
- pemigatinib
- pentobarbital
- pentoxifylline
- perampanel
- phenobarbital
- pibrentasvir
- pimavanserin
- pirtobrutinib
- ponatinib
- praziquantel
- pretomanid
- primaquine
- primidone
- propafenone
- propranolol
- quetiapine
- quinine
- quizartinib
- repotrectinib
- ribociclib
- rilpivirine
- ripretinib
- ritlecitinib
- roflumilast
- rolapitant
- safinamide
- samidorphan
- sebetralstat
- selpercatinib
- selumetinib
- simvastatin
- sirolimus albumin-bound
- sonidegib
- stiripentol
- suzetrigine
- tadalafil
- taletrectinib
- tamoxifen
- tasimelteon
- tazemetostat
- temsirolimus
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- valacyclovir
- valproic acid
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- voclosporin
- vonoprazan
- voxilaprevir
- zanubrutinib
- ziftomenib
- zileuton
Adverse Reactions .
Serious Reactions
- hepatotoxicity
- hepatic failure
- hepatic necrosis
- hepatitis, autoimmune
- seizures
Common Reactions
- ALT or AST incr.
- fatigue
- GGT incr.
- COVID-19
- musculoskeletal pain
- diarrhea
- headache
- seizures
- alk phos incr.
- nausea
- constipation
- abdominal pain
- bilirubin incr.
- appetite decr.
- potassium incr.
- neutrophils decr.
Safety/Monitoring .
Monitoring Parameters
chemistry profile, pregnancy test at baseline; LFTs at baseline, then q2wk x2mo, then qmo x2y, and as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of embryo-fetal toxicity based on animal data at 8x or greater systemic exposure
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective non-hormonal contraception during tx and x3mo after D/C in patients of childbearing potential and using effective contraception during tx and x3mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x2mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for vorasidenib: liver primarily; CYP450: 1A2 (primary), 2B6, 2C8, 2C9, 2C19, 2D6, 3A4 substrate
Excretion: for vorasidenib: feces 85% (56% unchanged), urine 4.5%; Half-life: 10 days
Subclass: Epigenetic Modifiers, Isocitrate Dehydrogenase (IDH) Inhibitors
Mechanism of Action
for vorasidenib: inhibits mutant and wild type isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) enzymes, leading to decr. 2-hydroxyglutarate (2-HG) levels, restoring cellular differentiation
Formulary .
No Formulary Selected
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