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Ibtrozi
taletrectinib
Adult Dosing .
Dosage forms: CAP: 200 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
ROS1-positive non-small cell lung CA, locally advanced or metastatic
- [600 mg PO qd]
- Info: give 2h before or after meal; do not open/crush/chew/dissolve cap
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: sun exposure during tx and for at least 5 days after D/C
- avoid: artificial UV light exposure during tx and for at least 5 days after D/C
- avoid: breastfeeding during tx and x3wk after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
taletrectinib
kinase inhibitor
- CYP3A4 substrate
- gastric pH sensitive
- hyperuricemic effects
- immunomodulatory effects
- photosensitivity
- prolongs QT interval (known)
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- cisapride
- dengue vaccine, live
- domperidone
- dronedarone
- influenza nasal vaccine, live
- levoketoconazole
- measles/mumps/rubella vaccine, live
- pimozide
- posaconazole
- rotavirus vaccine, live
- smallpox vaccine, live
- thioridazine
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adagrasib
- aminolevulinic acid topical
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- aprepitant
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- atazanavir
- avacopan
- azithromycin
- bedaquiline
- berotralstat
- bosentan
- butalbital
- cabozantinib
- carbamazepine
- cenobamate
- ceritinib
- chloramphenicol
- chloroquine
- cimetidine
- ciprofloxacin
- citalopram
- clarithromycin
- clofazimine
- cobicistat
- conivaptan
- crizotinib
- cyclosporine
- dabrafenib
- danazol
- darunavir
- degarelix
- desflurane
- desipramine
- dexlansoprazole
- dexmedetomidine
- dexmedetomidine injection
- diltiazem
- disopyramide
- dofetilide
- donepezil
- dordaviprone
- droperidol
- duvelisib
- efavirenz
- encorafenib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- esomeprazole
- etrasimod
- etravirine
- famotidine
- fedratinib
- fexinidazole
- flecainide
- fluconazole
- fluorouracil
- fluoxetine
- fosamprenavir
- foscarnet
- fosphenytoin
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydroxychloroquine
- hydroxyzine
- ibutilide
- idelalisib
- imatinib
- inotuzumab ozogamicin
- isavuconazonium
- isoflurane
- itraconazole
- ivabradine
- ivosidenib
- ketoconazole
- lansoprazole
- lefamulin
- lenacapavir
- letermovir
- leuprolide
- levofloxacin
- lofexidine
- lonafarnib
- loperamide
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- macimorelin
- mavacamten
- methadone
- mifepristone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- moxifloxacin
- nafcillin
- nefazodone
- nelfinavir
- netupitant
- nilotinib
- nirogacestat
- nizatidine
- oliceridine
- omeprazole
- ondansetron
- osimertinib
- oxaliplatin
- ozanimod
- pacritinib
- paliperidone
- palonosetron
- panobinostat
- pantoprazole
- pasireotide
- pazopanib
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pitolisant
- ponesimod
- porfimer
- primidone
- procainamide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- rabeprazole
- rabies vaccine
- relugolix
- repotrectinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- rilzabrutinib
- ritonavir
- romidepsin
- rucaparib
- selpercatinib
- sertraline
- sevoflurane
- siponimod
- solifenacin
- sorafenib
- sotalol
- sotorasib
- St. John's wort
- telavancin
- tetrabenazine
- tipranavir
- toremifene
- tramadol
- trazodone
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- vandetanib
- vemurafenib
- verapamil
- vonoprazan
- voriconazole
- ziprasidone
Monitor/Modify Tx
- albuterol
- albuterol inhaled
- alfuzosin
- allopurinol
- alprazolam
- aluminum hydroxide
- amisulpride
- amitriptyline
- amlodipine
- anthrax vaccine
- arformoterol inhaled
- asciminib
- atorvastatin
- belumosudil
- berberine
- bicalutamide
- buprenorphine
- calcium carbonate
- capivasertib
- chikungunya vaccine
- chlorpromazine
- chlorzoxazone
- cilostazol
- clomipramine
- clotrimazole oropharyngeal
- clozapine
- COVID-19 vaccine
- cranberry
- daridorexant
- dasatinib
- deutetrabenazine
- diosmin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- eliglustat
- escitalopram
- ethinyl estradiol (contraceptive)
- everolimus
- febuxostat
- finerenone
- fingolimod
- flibanserin
- fluvoxamine
- formoterol inhaled
- fosaprepitant
- fostamatinib
- fostemsavir
- gemtuzumab ozogamicin
- gepirone
- ginkgo
- givosiran
- glecaprevir
- goldenseal
- granisetron
- grazoprevir
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrocodone
- iloperidone
- influenza H5N1 vaccine
- influenza vaccine
- isoniazid
- istradefylline
- ivacaftor
- Japanese encephalitis vaccine
- kratom
- lapatinib
- larotrectinib
- lazertinib
- lenvatinib
- levalbuterol inhaled
- lomitapide
- lovastatin
- lumateperone
- lurasidone
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- maribavir
- mavorixafor
- mefloquine
- meningococcal vaccine
- meperidine
- metronidazole
- midostaurin
- mirtazapine
- nicardipine
- ofloxacin
- olodaterol inhaled
- osilodrostat
- palbociclib
- pegloticase
- peppermint
- pibrentasvir
- pirtobrutinib
- pneumococcal vaccine
- poliovirus vaccine
- pralsetinib
- primaquine
- probenecid
- promethazine
- quercetin
- ranolazine
- rasburicase
- remdesivir
- respiratory syncytial virus vaccine
- resveratrol
- ritlecitinib
- sacituzumab govitecan
- salmeterol inhaled
- sebetralstat
- smallpox/mpox vaccine, live
- sodium bicarbonate
- sodium citrate
- sodium zirconium cyclosilicate
- spironolactone
- stiripentol
- sunitinib
- tacrolimus
- tazemetostat
- terbutaline
- ticagrelor
- tick-borne encephalitis vaccine
- tolterodine
- tolvaptan
- treosulfan
- trofinetide
- typhoid vaccine
- valbenazine
- vardenafil
- venlafaxine
- vilanterol inhaled
- viloxazine
- voclosporin
- xanomeline
- zileuton
Caution Advised
- acitretin
- armodafinil
- belzutifan
- bexarotene
- brigatinib
- clobazam
- danshen
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- enasidenib
- eslicarbazepine acetate
- felbamate
- garlic
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- meropenem
- methoxsalen
- nevirapine
- odevixibat
- olutasidenib
- omaveloxolone
- oxcarbazepine
- perampanel
- pioglitazone
- prednisone
- rufinamide
- sarilumab
- sunvozertinib
- suzetrigine
- tecovirimat
- telotristat ethyl
- tocilizumab
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- verteporfin
- vinblastine
- vorasidenib
- zanubrutinib
Adverse Reactions .
Serious Reactions
- hepatotoxicity
- interstitial lung disease
- pneumonitis
- pneumonia
- pleural effusion
- QT prolongation
- hyperuricemia
- myalgia
- fractures
- drug rxn w/ eosinophilia and systemic symptoms
- photosensitivity
Common Reactions
- ALT or AST incr.
- diarrhea
- nausea
- vomiting
- dizziness
- rash
- constipation
- fatigue
- QT prolongation
- peripheral neuropathy
- appetite decr.
- cough
- dysgeusia
- hyperuricemia
- myalgia
- fractures
- interstitial lung disease
- pneumonitis
- pneumonia
- eye disorders
- photosensitivity
- CK incr.
- Hgb decr.
- cholesterol incr.
- triglycerides incr.
- Cr incr.
- lymphocytes decr.
- GGT incr.
- alk phos incr.
- calcium decr.
- neutrophils decr.
- albumin decr.
- bilirubin incr.
- potassium incr.
- sodium incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; ECG, electrolytes, uric acid at baseline, then periodically; LFTs at baseline, then q2wk x2mo, then qmo and as clinically indicated; CK q2wk x1mo, then as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of teratogenicity and embryo-fetal death based on animal data at 0.1x systemic exposure
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x3wk after D/C in patients of childbearing potential and male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x3wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver primarily, sulfation, acetylation; CYP450: 2C8, 2C9, 3A4 (primary) substrate
Excretion: feces 75% (15% unchanged), urine 11% (2.9% unchanged); Half-life: 66h
Subclass: Kinase Inhibitors, ROS1 Inhibitors ; Kinase Inhibitors, TRK Inhibitors
Mechanism of Action
inhibits proto-oncogene ROS1, tropomyosin receptor kinases (TRKs), leading to inhibition of tumor cell proliferation and survival
Formulary .
No Formulary Selected
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