Dabrafenib

Dabrafenib Brand Name– Tafinlar

What is Dabrafenib

Dabrafenib is a kinase inhibitor that inhibits cell growth in BRAF V600 mutation-positive tumors.

Using an FDA-approved test, confirm the presence of the BRAF V600 mutation in tumor specimens prior to initiation of treatment.

Dabrafenib is indicated as single-agent therapy for the treatment of unresectable or metastatic melanoma in patients with BRAF V600E mutations.

In combination with trametinib, dabrafenib is used for the treatment of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as adjuvant therapy following complete resection in patients with BRAF V600E or V600K mutation-positive melanoma and lymph node involvement, for the treatment of BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), and for the treatment of BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC) in patients with no satisfactory locoregional treatment options.

Dabrafenib is not indicated for the treatment of BRAF wild-type melanoma, NSCLC, or ATC.

Dabrafenib-treated patients who have glucose-6-phosphate dehydrogenase deficiency are at risk for developing hemolytic anemia; closely monitor these patients.

Indications

1. malignant melanoma
2. non-small cell lung cancer (NSCLC)
3. thyroid cancer

For the treatment of malignant melanoma

NOTE: Confirm the BRAF V600E or V600K mutation prior to starting therapy. Information on FDA-approved tests for the detection of BRAF V600 mutations is available at http://www.fda.gov/CompanionDiagnostics.

NOTE: Dabrafenib is not indicated in patients with wild-type BRAF melanoma.

NOTE: Dabrafenib has been designated as an orphan drug for the treatment of BRAF V600 mutation-positive melanoma by the FDA as a single-agent or in combination with trametinib.

Side Effects

1. alopecia
2. anemia
3. anemia
4. anorexia
5. arthralgia
6. arthralgia
7. asthenia
8. asthenia
9. back pain
10. back pain
11. bleeding
12. bleeding
13. blurred vision
14. bullous rash
15. cardiomyopathy
16. chills
17. chills
18. colitis
19. constipation
20. constipation
21. cough
22. dehydration
23. diarrhea
24. diarrhea
25. dizziness
26. dizziness
27. dyspnea
28. dyspnea
29. edema
30. elevated hepatic enzymes
31. elevated hepatic enzymes
32. epistaxis
33. fatigue
34. fatigue
35. fever
36. fever
37. GI bleeding
38. GI perforation
39. headache
40. headache
41. heart failure
42. hematoma
43. hematuria
44. hemoptysis
45. hyperglycemia
46. hyperglycemia
47. hyperkeratosis
48. hyperkeratosis
49. hypoalbuminemia
50. hypoalbuminemia
51. hyponatremia
52. hyponatremia
53. hypophosphatemia
54. hypophosphatemia
55. hypotension
56. infection
57. interstitial nephritis
58. intracranial bleeding
59. iritis
60. leukopenia
61. leukopenia
62. lymphopenia
63. lymphopenia
64. maculopapular rash
65. malaise
66. malaise
67. myalgia
68. myalgia
69. nausea
70. nausea
71. neutropenia
72. neutropenia
73. new primary malignancy
74. ocular pain
75. palmar-plantar erythrodysesthesia (hand and foot syndrome)
76. palmar-plantar erythrodysesthesia (hand and foot syndrome)
77. pancreatitis
78. panniculitis
79. peripheral edema
80. peripheral edema
81. pharyngitis
82. photophobia
83. pneumonitis
84. purpura
85. QT prolongation
86. rash
87. rash
88. renal failure (unspecified)
89. retroperitoneal bleeding
90. rhabdomyolysis
91. syncope
92. thrombocytopenia
93. thrombocytopenia
94. uveitis
95. vesicular rash
96. vomiting
97. vomiting
98. xerosis
99. xerosis

Monitoring Parameters

• echocardiogram
• laboratory monitoring not necessary
• multi-gated radionuclide angiography (MUGA)
• pregnancy testing
• skin cancer screening exam

Contraindications

• bleeding
• breast-feeding
• cardiac disease
• cardiomyopathy
• contraception requirements
• dehydration
• diabetes mellitus
• fever
• G6PD deficiency
• GI bleeding
• heart failure
• hemolytic anemia
• hyperglycemia
• hypotension
• infection
• infertility
• intracranial bleeding
• iritis
• male-mediated teratogenicity
• new primary malignancy
• pregnancy
• pregnancy testing
• renal failure
• reproductive risk
• serious rash
• sulfonamide hypersensitivity
• uveitis
• ventricular dysfunction

Interactions

• Abemaciclib
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Caffeine; Dihydrocodeine
• Acetaminophen; Codeine
• Acetaminophen; Hydrocodone
• Acetaminophen; Oxycodone
• Alfentanil
• Aliskiren; Amlodipine
• Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
• Alogliptin; Pioglitazone
• Amlodipine
• Amlodipine; Atorvastatin
• Amlodipine; Benazepril
• Amlodipine; Celecoxib
• Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
• Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
• Amlodipine; Olmesartan
• Amlodipine; Telmisartan
• Amlodipine; Valsartan
• Amoxicillin; Clarithromycin; Lansoprazole
• Amoxicillin; Clarithromycin; Omeprazole
• Aprepitant, Fosaprepitant
• Aspirin, ASA; Butalbital; Caffeine; Codeine
• Aspirin, ASA; Caffeine; Dihydrocodeine
• Aspirin, ASA; Carisoprodol; Codeine
• Aspirin, ASA; Citric Acid; Sodium Bicarbonate
• Aspirin, ASA; Omeprazole
• Aspirin, ASA; Oxycodone
• Atazanavir
• Atazanavir; Cobicistat
• Atropine; Hyoscyamine; Phenobarbital; Scopolamine
• Avanafil
• Avapritinib
• Axitinib
• Azilsartan
• Azilsartan; Chlorthalidone
• Bedaquiline
• Belladonna Alkaloids; Ergotamine; Phenobarbital
• Benzhydrocodone; Acetaminophen
• Boceprevir
• Brigatinib
• Bromocriptine
• Brompheniramine; Guaifenesin; Hydrocodone
• Brompheniramine; Hydrocodone; Pseudoephedrine
• Budesonide
• Budesonide; Formoterol
• Bupivacaine; Lidocaine
• Bupropion
• Bupropion; Naltrexone
• Buspirone
• Calcium Carbonate
• Calcium Carbonate; Magnesium Hydroxide
• Calcium Carbonate; Risedronate
• Calcium Carbonate; Simethicone
• Cannabidiol
• Carbamazepine
• Carbinoxamine; Hydrocodone; Phenylephrine
• Carbinoxamine; Hydrocodone; Pseudoephedrine
• Celecoxib
• Ceritinib
• Chlorpheniramine; Codeine
• Chlorpheniramine; Dihydrocodeine; Phenylephrine
• Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
• Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
• Chlorpheniramine; Hydrocodone
• Chlorpheniramine; Hydrocodone; Phenylephrine
• Chlorpheniramine; Hydrocodone; Pseudoephedrine
• Clarithromycin
• Clopidogrel
• Cobicistat
• Cobimetinib
• Codeine
• Codeine; Guaifenesin
• Codeine; Phenylephrine; Promethazine
• Codeine; Promethazine
• Conivaptan
• Daclatasvir
• Dapsone
• Darifenacin
• Darunavir
• Darunavir; Cobicistat
• Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Deflazacort
• Delavirdine
• Dexamethasone
• Diclofenac
• Diclofenac; Misoprostol
• Dihydrocodeine; Guaifenesin; Pseudoephedrine
• Diphenhydramine; Hydrocodone; Phenylephrine
• Diphenhydramine; Naproxen
• Dolutegravir; Rilpivirine
• Doravirine
• Doravirine; Lamivudine; Tenofovir disoproxil fumarate
• Doxorubicin
• Dronabinol
• Dronedarone
• Elbasvir; Grazoprevir
• Eletriptan
• Elvitegravir
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
• Emtricitabine; Rilpivirine; Tenofovir alafenamide
• Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
• Enalapril; Felodipine
• Encorafenib
• Entrectinib
• Eplerenone
• Erdafitinib
• Erlotinib
• Esomeprazole; Naproxen
• Ezetimibe; Simvastatin
• Fedratinib
• Felodipine
• Fosamprenavir
• Fosphenytoin
• Gemfibrozil
• Glasdegib
• Glimepiride
• Glimepiride; Pioglitazone
• Glimepiride; Rosiglitazone
• grapefruit juice
• Guaifenesin; Hydrocodone
• Guaifenesin; Hydrocodone; Pseudoephedrine
• Homatropine; Hydrocodone
• Hydrochlorothiazide, HCTZ; Losartan
• Hydrocodone
• Hydrocodone; Ibuprofen
• Hydrocodone; Phenylephrine
• Hydrocodone; Potassium Guaiacolsulfonate
• Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
• Hydrocodone; Pseudoephedrine
• Ibrutinib
• Ibuprofen; Oxycodone
• Idelalisib
• Ifosfamide
• Indinavir
• Isavuconazonium
• Itraconazole
• Ivabradine
• Ketoconazole
• Lansoprazole; Naproxen
• Lefamulin
• Lesinurad
• Lesinurad; Allopurinol
• Letermovir
• Lidocaine
• Lomitapide
• Loperamide
• Loperamide; Simethicone
• Lopinavir; Ritonavir
• Lorlatinib
• Losartan
• Lovastatin
• Lovastatin; Niacin
• Lumacaftor; Ivacaftor
• Lumateperone
• Lurasidone
• Maraviroc
• Meloxicam
• Metformin; Pioglitazone
• Metformin; Repaglinide
• Metformin; Rosiglitazone
• Midazolam
• Naloxegol
• Naproxen
• Naproxen; Pseudoephedrine
• Naproxen; Sumatriptan
• Nateglinide
• Nefazodone
• Neratinib
• Netupitant, Fosnetupitant; Palonosetron
• Niacin; Simvastatin
• Nisoldipine
• Non-oral combination contraceptives
• Olaparib
• Ombitasvir; Paritaprevir; Ritonavir
• Omeprazole
• Omeprazole; Amoxicillin; Rifabutin
• Omeprazole; Sodium Bicarbonate
• Oral Contraceptives
• Ospemifene
• Oxycodone
• Perampanel
• Perindopril; Amlodipine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pioglitazone
• Posaconazole
• Praziquantel
• Quetiapine
• Repaglinide
• Ribociclib
• Ribociclib; Letrozole
• Rilpivirine
• Rimegepant
• Ritonavir
• Rosiglitazone
• Saquinavir
• Sildenafil
• Simvastatin
• Simvastatin; Sitagliptin
• Siponimod
• Sirolimus
• Sodium Bicarbonate
• Sofosbuvir; Velpatasvir
• Sofosbuvir; Velpatasvir; Voxilaprevir
• Sonidegib
• Sufentanil
• Sunitinib
• Tacrolimus
• Tasimelteon
• Tazemetostat
• Telotristat Ethyl
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Ubrogepant
• Ulipristal
• Venetoclax
• Vincristine
• Vincristine Liposomal
• Vorapaxar
• Voriconazole
• Voxelotor
• Warfarin
• Zanubrutinib
• Zolpidem