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Tafinlar
dabrafenib
Adult Dosing .
Dosage forms: CAP: 50 mg, 75 mg; DISPERSE TAB: 10 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
- [adjuvant tx]
- Dose: 150 mg PO bid for up to 1y; Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [unresectable or metastatic dz]
- Dose: 150 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
BRAF V600E-positive melanoma
- [unresectable or metastatic dz, monotherapy]
- Dose: 150 mg PO bid; Info: give at least 1h before or 2h after meals; do not open cap
BRAF V600E-positive non-small cell lung CA, metastatic
- [150 mg PO bid]
- Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
BRAF V600E-positive anaplastic thyroid CA, locally advanced or metastatic
- [150 mg PO bid]
- Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
BRAF V600E-positive solid tumors, unresectable or metastatic
- [150 mg PO bid]
- Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
BRAF V600E-positive glioma, low-grade
- [150 mg PO bid]
- Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: 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 .
- Dosage forms: CAP: 50 mg, 75 mg; DISPERSE TAB: 10 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-positive solid tumors, unresectable or metastatic
- [cap form, 1 yo and older, 26-37 kg]
- Dose: 75 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [cap form, 1 yo and older, 38-50 kg]
- Dose: 100 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [cap form, 1 yo and older, >51 kg]
- Dose: 150 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [disperse tab form, 1 yo and older, 8-9 kg]
- Dose: 20 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 10-13 kg]
- Dose: 30 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 14-17 kg]
- Dose: 40 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 18-21 kg]
- Dose: 50 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 22-25 kg]
- Dose: 60 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 26-29 kg]
- Dose: 70 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 30-33 kg]
- Dose: 80 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 34-37 kg]
- Dose: 90 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 38-41 kg]
- Dose: 100 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 42-45 kg]
- Dose: 110 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 46-50 kg]
- Dose: 130 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, >51 kg]
- Dose: 150 mg PO bid; Info: for pts who have progressed after prior tx; not for pts w/ colorectal CA; use w/ trametinib; give at least 1h before or 2h after meals
BRAF V600E-positive glioma, low-grade
- [cap form, 1 yo and older, 26-37 kg]
- Dose: 75 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [cap form, 1 yo and older, 38-50 kg]
- Dose: 100 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [cap form, 1 yo and older, >51 kg]
- Dose: 150 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals; do not open cap
- [disperse tab form, 1 yo and older, 8-9 kg]
- Dose: 20 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 10-13 kg]
- Dose: 30 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 14-17 kg]
- Dose: 40 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 18-21 kg]
- Dose: 50 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 22-25 kg]
- Dose: 60 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 26-29 kg]
- Dose: 70 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 30-33 kg]
- Dose: 80 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 34-37 kg]
- Dose: 90 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 38-41 kg]
- Dose: 100 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 42-45 kg]
- Dose: 110 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, 46-50 kg]
- Dose: 130 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
- [disperse tab form, 1 yo and older, >51 kg]
- Dose: 150 mg PO bid; Info: use w/ trametinib; give at least 1h before or 2h after meals
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: 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
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- tumor, BRAF wild-type
- non-cutaneous malignancy, RAS mutation-positive
- colorectal CA use
- avoid: breastfeeding during tx and x2wk after D/C
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
- caution: G6PD deficiency
- caution: diabetes mellitus
- caution: hyperglycemia
Drug Interactions .
Overview
dabrafenib
kinase inhibitor
- CYP2C8 substrate
- CYP3A4 substrate
- CYP2C9 inducer, minor
- CYP3A4 inducer, major
- cardiotoxic effects
- hyperglycemic effects
Contraindicated
- dasabuvir
- lonafarnib
- mavacamten
- methenamine
- paritaprevir
- ranolazine
- ritonavir
Avoid/Use Alternative
- abemaciclib
- adagrasib
- alfentanil
- alpelisib
- aprepitant
- aripiprazole
- aripiprazole lauroxil
- artemether/lumefantrine
- atazanavir
- atogepant
- avacopan
- avanafil
- avapritinib
- axitinib
- bedaquiline
- bictegravir
- bortezomib
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- cabozantinib
- capivasertib
- capmatinib
- cariprazine
- ceritinib
- chloramphenicol
- clarithromycin
- cobicistat
- cobimetinib
- codeine
- copanlisib
- crizotinib
- daridorexant
- darolutamide
- dasatinib
- deflazacort
- desogestrel (contraceptive)
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- dolutegravir
- doravirine
- doxorubicin
- dronedarone
- drospirenone (contraceptive)
- duvelisib
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- entrectinib
- epirubicin
- erdafitinib
- erlotinib
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- everolimus
- fedratinib
- felodipine
- fentanyl
- finerenone
- flibanserin
- fosamprenavir
- fosaprepitant
- fostamatinib
- fruquintinib
- ganaxolone
- gemfibrozil
- gilteritinib
- glasdegib
- glecaprevir
- grazoprevir
- hydrocodone
- ibrexafungerp
- ibrutinib
- idarubicin
- idelalisib
- imatinib
- infigratinib
- irinotecan
- isavuconazonium
- isradipine
- istradefylline
- itraconazole
- ivacaftor
- ivosidenib
- ixazomib
- ketoconazole
- larotrectinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- linagliptin
- lopinavir/ritonavir
- lorlatinib
- lumateperone
- macitentan
- maraviroc
- medroxyprogesterone (contraceptive)
- meperidine
- methadone
- midazolam
- midostaurin
- mifepristone
- mitapivat
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nintedanib
- nirmatrelvir
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- oxycodone
- pacritinib
- palbociclib
- palovarotene
- pazopanib
- pemigatinib
- perampanel
- pimavanserin
- pirtobrutinib
- ponatinib
- posaconazole
- pralsetinib
- praziquantel
- pretomanid
- quinine
- quizartinib
- repotrectinib
- ribociclib
- rilpivirine
- rimegepant
- ripretinib
- rivaroxaban
- roflumilast
- rolapitant
- romidepsin
- samidorphan
- saquinavir
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- simvastatin
- siponimod
- sonidegib
- stiripentol
- sufentanil
- sunitinib
- tadalafil
- tamoxifen
- tasimelteon
- tazemetostat
- temsirolimus
- tezacaftor/ivacaftor
- thiotepa
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- tramadol
- tucatinib
- ulipristal (post-coital contraceptive)
- valbenazine
- velpatasvir
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- voriconazole
- voxelotor
- voxilaprevir
- zanubrutinib
- zuranolone
Monitor/Modify Tx
- abiraterone acetate
- acalabrutinib
- acarbose
- adalimumab
- ado-trastuzumab emtansine
- aldesleukin
- alogliptin
- aminophylline
- amitriptyline
- amlodipine
- anagrelide
- asciminib
- avatrombopag
- avelumab
- betamethasone
- bevacizumab
- bexagliflozin
- bezlotoxumab
- binimetinib
- brexpiprazole
- bromocriptine
- butorphanol
- calcitriol
- canagliflozin
- capecitabine
- carbamazepine
- carfilzomib
- certolizumab pegol
- cholecalciferol (vitamin D3)
- cilostazol
- clozapine
- colesevelam
- cyclophosphamide
- cyclosporine
- dapagliflozin
- daunorubicin
- disopyramide
- doxercalciferol
- dulaglutide
- empagliflozin
- encorafenib
- ertugliflozin
- etanercept
- ethosuximide
- exemestane
- exenatide
- fam-trastuzumab deruxtecan
- fexinidazole
- fludrocortisone
- fluorouracil
- fosphenytoin
- gefitinib
- glimepiride
- glipizide
- glyburide
- golimumab
- guanfacine
- haloperidol
- hydrocortisone
- hydroxychloroquine
- ifosfamide
- imipramine
- infliximab
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- lapatinib
- lenvatinib
- liraglutide
- lurasidone
- macimorelin
- margetuximab
- metformin
- mirtazapine
- mitoxantrone
- nateglinide
- nimodipine
- nortriptyline
- osimertinib
- peginterferon beta 1a
- pertuzumab
- phenytoin
- pioglitazone
- pramlintide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- repaglinide
- ropeginterferon alfa-2b
- rosiglitazone
- saxagliptin
- semaglutide
- sildenafil
- sirolimus
- sitagliptin
- sorafenib
- tacrolimus
- theophylline
- tiagabine
- tirzepatide
- tivozanib
- trabectedin
- trastuzumab
- ubrogepant
- vandetanib
- vilazodone
- vortioxetine
- warfarin
Caution Advised
- albendazole
- aliskiren
- alprazolam
- amiodarone
- apalutamide
- apixaban
- apremilast
- aripiprazole bimonthly injection
- atorvastatin
- belumosudil
- bosentan
- brentuximab vedotin
- budesonide
- butalbital
- cannabidiol
- cannabis
- citalopram
- clindamycin
- colchicine
- cortisone
- dapsone
- darunavir
- dexamethasone
- diazepam
- drospirenone (hormone replacement)
- efavirenz
- enfortumab vedotin
- enzalutamide
- eravacycline
- erythromycin
- escitalopram
- esomeprazole
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- eszopiclone
- ethinyl estradiol (hormone replacement)
- etoposide
- etrasimod
- etravirine
- felbamate
- fenfluramine
- fesoterodine
- finasteride
- fostemsavir
- futibatinib
- gepirone
- isotretinoin
- ivabradine
- ixabepilone
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- lovastatin
- lumacaftor/ivacaftor
- maribavir
- mavorixafor
- medroxyprogesterone (hormone replacement)
- mefloquine
- methylergonovine
- methylprednisolone
- metoclopramide
- mitotane
- norethindrone acetate (hormone replacement)
- norgestimate (hormone replacement)
- omeprazole
- ondansetron
- ospemifene
- oxcarbazepine
- paclitaxel
- panobinostat
- pentobarbital
- pexidartinib
- phenobarbital
- pitolisant
- polatuzumab vedotin
- prednisolone
- prednisone
- primidone
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- quinidine (CYP2D6 inhibitor)
- ramelteon
- red yeast rice
- regorafenib
- relugolix
- rifabutin
- rifampin
- risperidone
- ritlecitinib
- ruxolitinib
- sertraline
- sirolimus albumin-bound
- sotorasib
- sparsentan
- St. John's wort
- suvorexant
- terbinafine
- tisotumab vedotin
- trazodone
- tretinoin
- triamcinolone
- triazolam
- upadacitinib
- vemurafenib
- vorapaxar
- zaleplon
- zolpidem
- zonisamide
Adverse Reactions .
Serious Reactions
- cutaneous squamous cell CA
- keratoacanthoma
- basal cell CA
- melanoma, malignant
- malignancy, non-cutaneous
- uveitis
- febrile rxn, serious
- hyperglycemia
- pancreatitis
- interstitial nephritis
- hand-foot syndrome
- hypersensitivity rxn
- skin rxn, severe (combo tx)
- Stevens-Johnson syndrome (combo tx)
- drug rxn w/ eosinophilia and systemic sx (combo tx)
- hemorrhage, severe (combo tx)
- neutropenia (combo tx)
- cardiomyopathy (combo tx)
- AV block (combo tx)
- rhabdomyolysis (combo tx)
- sarcoidosis (combo tx)
- hemophagocytic lymphohistiocytosis (combo tx)
Common Reactions
- hyperkeratosis
- headache
- fever
- papilloma
- arthralgia
- alopecia
- hand-foot syndrome
- rash
- hemorrhage (combo tx)
- hyperglycemia
- cough
- back pain
- myalgia
- constipation
- nasopharyngitis
- pancreatitis
- hypersensitivity rxn
- interstitial nephritis
- cutaneous squamous cell CA
- cardiomyopathy (combo tx)
- febrile rxn, serious
- keratoacanthoma
- basal cell CA
- uveitis
- photosensitivity
- hypophosphatemia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LVEF at baseline, 1mo after tx start, then q2-3mo during tx; dermatologic exams at baseline, q2mo during tx, and for up to 6mo after D/C; glucose at baseline and as clinically indicated if diabetes or diabetes risk; ophthalmic exam
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of fetal harm, incl. teratogenicity and embryo-fetal toxicity and death, based on animal data at 3x 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 female pts and using condoms, even after vasectomy, during tx and for at least 2wk after D/C in male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x2wk after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C8, 3A4 substrate; Info: active metabolites
Excretion: feces 71%, urine 23%; Half-life: 8h
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: Novartis Pharmaceuticals Corp.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/tafinlar
oral capsule:
- 50 mg (120 ea): $9,195.00
- 75 mg (120 ea): $11,848.00
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