All the Active Ingredient Drugs
Protein Kinase Inhibitor. Dabrafenib 50 mg, 75 mg. HARD CAPS.: 28,120 × 50, 75 mg. The recom. dose of dabrafenib, either used as monother. or in comb. with trametinib, is 150 mg (two 75 mg caps.) twice dly. (corresp. to a total dly. dose of 300 mg). The recomm. dose of trametinib, when used in comb. with dabrafenib, is 2 mg once dly. (QD).
Duration of tmt.: Tmt. should continue until the pt. no longer derives benefit or the develop. of unaccept. toxicity. In the adjuv. melanoma setting, pts. should be treated for a period of 12 mnths. unless there is dis. recurrence or unaccept. toxic.
Before taking dabrafenib, pts. must have confirm. of tumour BRAF V600 mutat. using a validated test. In ATC, confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of tmt. with dabrafenib and trametinib.
The efficacy and safety of dabrafenib have not been established in pts. with wild-type BRAF melanoma, or wild-type BRAF NSCLC or wild-type BRAF ATC.
Tmt. should continue until the pt. no longer derives benefit or the develop. of unaccept. toxic. In the adjuvant melanoma setting, pts. should be treated for a period of 12 mnths. unless there is dis. recur. or unaccept. toxicity.
In ATC, tmt. should continue until disease recurrence or unaccept. toxicity. See lit.
Dabrafenib as monother. or in comb. with trametinib is indic. for the tmt. of adult pts. with unresect./metastat. melanoma with a BRAF V600 mutation.
Non-small cell lung cancer (NSCLC): In comb. with trametinib is indic. for the tmt. of adult pts. with advance. NSCLC with a BRAF V600 mutation.
Adjuvant tmt. of melanoma: In comb. with trametinib is indic. for the adjuvant tmt. of adult pts. with Stage III melanoma with BRAF V600 mutation, follow. complete resect.
Anaplastic Thyroid Cancer (ATC): Dabrafenib is indicated, in comb. with trametinib, for the tmt. of pts. with locally advanced or metast. anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional tmt. options.
C/I: Hypersens.
