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Braftovi
encorafenib
Adult Dosing .
Dosage forms: CAP: 75 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
BRAF V600E- or V600K-positive melanoma, unresectable or metastatic
- [450 mg PO qd]
- Info: use w/ binimetinib; decr. dose to max 300 mg PO qd if binimetinib withheld
BRAF V600E-positive colorectal CA, metastatic
- [first-line tx]
- Dose: 300 mg PO qd; Info: part of multi-drug chemo regimen
- [previously treated dz]
- Dose: 300 mg PO qd; Info: use w/ cetuximab
BRAF V600E-positive non-small cell lung CA, metastatic
- [450 mg PO qd]
- Info: use w/ binimetinib; decr. dose to max 300 mg PO qd if binimetinib withheld
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A: no adjustment; Child-Pugh Class B or C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- tumor, BRAF wild-type
- non-cutaneous malignancy, RAS mutation-positive
- QTc >500 msec
- electrolyte abnormalities, uncorrected
- long QT syndrome, congenital
- avoid: breastfeeding during tx and x2wk after D/C
- caution: pts of childbearing potential
- caution: QT prolongation family hx
- caution: torsades de pointes hx
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
- caution: LVEF < lower limit of normal
- caution: cardiovascular dz risk
Drug Interactions .
Overview
encorafenib
kinase inhibitor
- CYP3A4 substrate
- BCRP inhibitor
- OATP1B1 inhibitor, weak
- OATP1B3 inhibitor, weak
- CYP3A4 inducer, strong
- antiplatelet/anticoagulant effects
- cardiotoxic effects
- 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
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
- arsenic trioxide
- asenapine
- atogepant
- atrasentan
- avacopan
- avanafil
- avapritinib
- axitinib
- azithromycin
- bedaquiline
- berotralstat
- bictegravir
- bortezomib
- bosutinib
- brigatinib
- brincidofovir
- buprenorphine
- buspirone
- butalbital
- cabozantinib
- capivasertib
- capmatinib
- carbamazepine
- cariprazine
- ceritinib
- chloramphenicol
- chloroquine
- ciprofloxacin
- citalopram
- cladribine oral
- clarithromycin
- clofazimine
- clozapine
- cobicistat
- cobimetinib
- codeine
- conivaptan
- copanlisib
- crizotinib
- cyclosporine
- danazol
- daridorexant
- darolutamide
- darunavir
- dasatinib
- defactinib
- deflazacort
- degarelix
- desflurane
- desipramine
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- diazoxide
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- disopyramide
- dofetilide
- dolutegravir
- donepezil
- doxorubicin
- droperidol
- drospirenone (contraceptive)
- duvelisib
- efavirenz
- elacestrant
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- ensartinib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- erdafitinib
- eribulin
- erlotinib
- erythromycin
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etrasimod
- everolimus
- fedratinib
- felodipine
- fenfluramine
- fentanyl
- fexinidazole
- finerenone
- flecainide
- flibanserin
- fluconazole
- fluorouracil
- fluoxetine
- fosamprenavir
- fosaprepitant
- foscarnet
- fosphenytoin
- fostamatinib
- fruquintinib
- futibatinib
- ganaxolone
- gepirone
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- glecaprevir
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibrexafungerp
- ibrutinib
- ibutilide
- idarubicin
- idelalisib
- iloperidone
- imatinib
- inotuzumab ozogamicin
- irinotecan
- isoflurane
- isradipine
- istradefylline
- itraconazole
- ivabradine
- ivacaftor
- ivosidenib
- 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
- mitapivat
- mitotane
- mobocertinib
- moxifloxacin
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- nintedanib
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- ondansetron
- osimertinib
- oxycodone
- ozanimod
- palbociclib
- paliperidone
- palonosetron
- palovarotene
- panobinostat
- pasireotide
- pazopanib
- pemigatinib
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pirtobrutinib
- pitolisant
- ponatinib
- ponesimod
- pralsetinib
- pretomanid
- primidone
- procainamide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- regorafenib
- relugolix
- repotrectinib
- resmetirom
- revumenib
- ribociclib
- rifabutin
- rifampin
- rilpivirine
- rimegepant
- ripretinib
- ritlecitinib
- ritonavir
- rivaroxaban
- roflumilast
- rolapitant
- romidepsin
- rucaparib
- samidorphan
- sebetralstat
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sertraline
- sevoflurane
- simvastatin
- siponimod
- sirolimus
- sirolimus albumin-bound
- solifenacin
- sonidegib
- sorafenib
- sotalol
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- sufentanil
- sunitinib
- sunvozertinib
- suzetrigine
- tadalafil
- tamoxifen
- tasimelteon
- tazemetostat
- telavancin
- temsirolimus
- tetrabenazine
- tezacaftor/ivacaftor
- thiotepa
- ticagrelor
- tivozanib
- tofacitinib
- tolvaptan
- topotecan
- toremifene
- trabectedin
- tramadol
- trazodone
- tretinoin
- triazolam
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- ubrogepant
- ulipristal (post-coital contraceptive)
- upadacitinib
- valbenazine
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- vorapaxar
- voriconazole
- voxelotor
- voxilaprevir
- zaleplon
- zanubrutinib
- zavegepant
- ziprasidone
- zolpidem
- zuranolone
Monitor/Modify Tx
- adalimumab
- ado-trastuzumab emtansine
- afatinib
- albuterol
- albuterol inhaled
- aldesleukin
- alfuzosin
- alogliptin
- alprazolam
- alteplase
- aminophylline
- amisulpride
- amitriptyline
- amlodipine
- anacaulase topical
- antithrombin
- arformoterol inhaled
- argatroban
- aripiprazole oral
- asciminib
- asparaginase
- aspirin
- atorvastatin
- avatrombopag
- avelumab
- belumosudil
- berberine
- betamethasone
- bevacizumab
- bezlotoxumab
- bicalutamide
- binimetinib
- bivalirudin
- brentuximab vedotin
- brexpiprazole
- bromelain
- bromfenac ophthalmic
- butorphanol
- cabazitaxel
- calaspargase
- calcitriol
- cangrelor
- cannabidiol
- capecitabine
- caplacizumab
- carfilzomib
- celecoxib
- certolizumab pegol
- chlorpromazine
- chlorzoxazone
- cholecalciferol (vitamin D3)
- cilostazol
- cimetidine
- clobazam
- clomipramine
- clopidogrel
- clotrimazole oropharyngeal
- collagenase clostridium histolyticum
- cortisone
- cranberry
- crinecerfont
- cyclophosphamide
- cysteamine
- dabigatran
- dabrafenib
- dalteparin
- danshen
- daunorubicin
- deferasirox
- defibrotide
- desvenlafaxine
- deutetrabenazine
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- dimethyl fumarate
- diosmin
- dipyridamole
- diroximel fumarate
- doxercalciferol
- duloxetine
- edoxaban
- eluxadoline
- enoxaparin
- epoprostenol
- eptifibatide
- eravacycline
- escitalopram
- etanercept
- ethanol
- ethosuximide
- etodolac
- evening primrose oil
- exemestane
- fam-trastuzumab deruxtecan
- fenoprofen
- fenugreek
- fingolimod
- fludrocortisone
- flurbiprofen
- flurbiprofen ophthalmic
- fluvastatin
- fluvoxamine
- fondaparinux
- formoterol inhaled
- garlic
- gefitinib
- gemtuzumab ozogamicin
- ginkgo
- givosiran
- goldenseal
- golimumab
- granisetron
- guanfacine
- heparin
- hydrocortisone
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- ifosfamide
- iloprost inhaled
- imipramine
- indomethacin
- infliximab
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoniazid
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- kratom
- lenvatinib
- levalbuterol inhaled
- levomilnacipran
- lifileucel
- lomitapide
- lovastatin
- magnesium salicylate
- margetuximab
- meclofenamate
- mefenamic acid
- mefloquine
- meloxicam
- methotrexate
- methyl salicylate topical
- methylprednisolone
- metronidazole
- milnacipran
- mirdametinib
- mirtazapine
- mitoxantrone
- momelotinib
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- naproxen
- nateglinide
- nattokinase
- nepafenac ophthalmic
- niacin (vitamin B3)
- nortriptyline
- nusinersen
- ofloxacin
- olodaterol inhaled
- omega-3-acid
- osilodrostat
- oxaliplatin
- oxaprozin
- oxcarbazepine
- paroxetine
- pegaspargase
- peginterferon beta 1a
- penicillin G
- pentosan polysulfate sodium
- pentoxifylline
- peppermint
- perampanel
- pertuzumab
- pibrentasvir
- pioglitazone
- piperacillin
- piroxicam
- pitavastatin
- plasminogen, human
- porfimer
- prasugrel
- pravastatin
- prednisolone
- prednisone
- primaquine
- promethazine
- quercetin
- ramucirumab
- ranibizumab
- red yeast rice
- remdesivir
- repaglinide
- resveratrol
- reteplase
- revakinagene taroretcel
- riociguat
- risperidone
- ropeginterferon alfa-2b
- rosiglitazone
- rosuvastatin
- sacituzumab govitecan
- salmeterol inhaled
- salsalate
- saw palmetto
- saxagliptin
- sildenafil
- sitagliptin
- sotatercept
- spironolactone
- sulindac
- tacrolimus
- talazoparib
- tenecteplase
- tenofovir alafenamide
- tenofovir disoproxil
- terbutaline
- theophylline
- tiagabine
- tirofiban
- tisotumab vedotin
- tolmetin
- tolterodine
- tovorafenib
- trametinib
- trastuzumab
- treosulfan
- treprostinil
- triamcinolone
- trofinetide
- vadadustat
- valproic acid
- vardenafil
- venlafaxine
- vilanterol inhaled
- vilazodone
- viloxazine
- vinpocetine
- vortioxetine
- warfarin
- willow bark
- xanomeline
- zanidatamab
- zenocutuzumab
- zileuton
- ziv-aflibercept
- zonisamide
Caution Advised
- albendazole
- aliskiren
- armodafinil
- bosentan
- bromocriptine
- budesonide
- cannabis
- clindamycin
- clonazepam
- colchicine
- dapsone
- diazepam
- dronabinol
- drospirenone (hormone replacement)
- enfortumab vedotin
- esomeprazole
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- eszopiclone
- ethinyl estradiol (hormone replacement)
- etoposide
- etravirine
- felbamate
- fesoterodine
- finasteride
- glyburide
- isotretinoin
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- medroxyprogesterone (hormone replacement)
- methylergonovine
- metoclopramide
- modafinil
- montelukast
- norethindrone (hormone replacement)
- olanzapine
- omeprazole
- ospemifene
- paclitaxel
- polatuzumab vedotin
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- ramelteon
- ruxolitinib
- seladelpar
- selegiline
- sulfasalazine
- suvorexant
- terbinafine
- tinidazole
- topiramate
Adverse Reactions .
Serious Reactions
- basal cell CA
- squamous cell CA
- melanoma, malignant
- keratoacanthoma
- malignancy, non-cutaneous
- hemorrhage
- uveitis (combo w/ binimetinib)
- cardiomyopathy (combo w/ binimetinib)
- hepatotoxicity (combo w/ binimetinib)
- QT prolongation
- arrhythmia
- MI
- HTN
- pleural effusion
- facial nerve paralysis
- peripheral neuropathy
- hand-foot syndrome
- hypersensitivity rxn
- anemia
- neutropenia
- thrombocytopenia
- lymphopenia
- pneumonia
- pancreatitis
Common Reactions
- hand-foot syndrome
- fatigue
- nausea
- abdominal pain
- vomiting
- rash
- diarrhea
- arthralgia
- constipation
- headache
- fever
- hemorrhage
- erythema
- myopathy
- back pain
- appetite decr.
- xeroderma
- acneiform dermatitis
- dysgeusia
- peripheral neuropathy
- pruritus
- hyperkeratosis
- pancreatitis
- musculoskeletal pain
- dizziness
- extremity pain
- alopecia
- insomnia
- melanocytic nevus
- facial paresis
- hypersensitivity rxn
- visual impairment
- dyspnea
- cough
- edema
- panniculitis
- cardiomyopathy
- weight incr.
- HTN
- photosensitivity
- Cr incr.
- anemia
- ALT or AST incr.
- alk phos incr.
- hyperglycemia
- lymphopenia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LFTs at baseline, then qmo and as clinically indicated; LVEF at baseline, 1mo after tx start, then q2-3mo during tx; ECG, electrolytes incl. Mg at baseline and during tx; dermatologic exams at baseline, q2mo during tx, and for up to 6mo after D/C; ophthalmic exam
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, incl. embryo-fetal death, skeletal variations, decr. fetal wt, based on animal data at 26x and 178x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective non-hormonal contraception during tx and x2wk after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x2wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C19, 2D6, 3A4 (primary) substrate
Excretion: feces 47% (5% unchanged), urine 47% (2% unchanged); Half-life: 3.5h
Subclass: Kinase Inhibitors, BRAF Inhibitors
Mechanism of Action
inhibits BRAF V600E and V600K protein kinases, leading to inhibition of tumor cell proliferation
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Pfizer Inc.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/braftovi
oral capsule:
- 75 mg (1 carton, 2 bottles of 60 capsules): $13,333.00
oral capsule:
- 75 mg (1 carton, 2 bottles of 90 capsules): $13,333.00
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