Four Star
Concise Prescribing Info
Dabrafenib mesilate
Monotherapy or in combination w/ trametinib for the treatment of adult patients w/ unresectable or metastatic melanoma w/ a BRAF V600 mutation. In combination w/ trametinib for the adjuvant treatment of adult patients w/ Stage III melanoma w/ BRAF V600 mutation, following complete resection. In combination w/ trametinib for the treatment of adult patients w/ advanced non-small cell lung cancer (NSCLC) w/ a BRAF V600 mutation.
Dosage/Direction for Use
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meal. Swallow whole w/ water, do not chew/open. Do not mix w/ food or liqd. Take at the same time each day. When dabrafenib & trametinib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day w/ either the morning or evening dose of dabrafenib.
Special Precautions
Patients w/ wild-type BRAF melanoma or wild-type BRAF NSCLC; patients who have progressed on a prior BRAF inhibitor; patients w/ a BRAF V600 mutation positive melanoma which has metastasised to the brain. Risk of new malignancies, cutaneous & non-cutaneous; haemorrhage; ophthalmologic reactions including uveitis, iridocyclitis & iritis; pyrexia; decreased left ventricular ejection fraction/left ventricular dysfunction; renal failure; hepatic adverse events; HTN; pneumonitis or interstitial lung disease; rash; rhabdomyolysis; pancreatitis; pulmonary embolism or DVT; colitis & GI perforation. Severe renal impairmet. Moderate to severe hepatic impairment. Avoid concomitant use w/ potent CYP2C8 & CYP3A4 inducers. Use w/ caution when co-administered w/ warfarin or digoxin. Women of childbearing potential must use effective methods of contraception during therapy & for 4 wk following discontinuation of dabrafenib & 4 mth following the last dose of trametinib when given in combination w/ dabrafenib. May decrease efficacy of hormonal contraceptives. May impair male & female fertility. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Monotherapy: Hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash, vomiting. Decreased appetite; cough; diarrhoea; palmar-plantar erythrodysaesthesia syndrome; myalgia, pain in extremity; chills, asthenia. Combination therapy: Pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia, rash. Nasopharyngitis; decreased appetite; dizziness; HTN, haemorrhage; cough; abdominal pain, constipation; dry skin, pruritus, erythema; myalgia, pain in extremity, muscle spasms; asthenia, oedema peripheral; flu-like illness; increased ALT & AST.
Drug Interactions
Increased conc w/ strong CYP2C8 or CYP3A4 inhibitors eg, ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir. Decreased conc w/ potent CYP2C8 or CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb or St. John's wort. Reduced plasma levels of CYP3A4, CYP2Cs, CYP2B6, UGT or transporter (eg, Pgp or MRP-2) substrates. Decreased exposure of oral midazolam, digoxin, warfarin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EC02 - dabrafenib ; Belongs to the class of B-Raf serine-threonine kinase (BRAF) inhibitors. Used in the treatment of cancer.
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