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Dabrafenib

    Brands

    DEA Class; Rx

    Common Brand Names; Tafinlar

    • Antineoplastics, BRAF Kinase Inhibitor

    BRAF kinase inhibitor; confirm presence of the BRAF V600 mutation using an FDA-approved test
    Used as a single-agent in advanced BRAF V600 mutation-positive melanoma or in combination with trametinib for BRAF V600E mutation-positive solid tumors
    Monitor patients who have glucose-6-phosphate dehydrogenase deficiency for hemolytic anemia

    Indicated, in combination with trametinib, for locally advanced or metastatic anaplastic thyroid cancer (ATC) in adults with no satisfactory locoregional treatment options

    Indicated in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation in patients who have progressed following prior treatment and have no satisfactory alternative treatment options

    For the treatment of malignant melanoma.

    For the treatment of non-small cell lung cancer (NSCLC).

    For the treatment of thyroid cancer.

    —

    • Adverse effects listed are all grades of severity unless indicated otherwise
    • * Note: Adverse reactions are for patients treated with dabrafenib and trametinib
    • Hyperglycemia (50%)
    • Hypophosphatemia (37%)
    • Hyperkeratosis (37%)
    • Headache (28%)
    • Arthralgia (27%)
    • Papilloma (27%)
    • Alopecia (22%)
    • Palmar-planter erythrodysesthesia syndrome (20%)
    • Increased alkaline phosphatase (19%)
    • Rash (17%)
    • Back pain (12%)
    • Cough (12%)
    • Myalgia (11%)
    • Constipation (11%)

    Increases incidence of cutaneous squamous cell carcinoma, keratoacanthoma, and new incidence melanoma; perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following discontinuation

    BRAF inhibitors may cause paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells; confirm evidence of BRAF V600E mutation status prior to initiation

    Based on its mechanism of action, dabrafenib may promote growth and development of malignancies with activation of RAS through mutation or other mechanisms

    Hemorrhage, including major hemorrhages, can occur when used in combination with trametinib; permanently discontinue therapy for all Grade 4 hemorrhagic events and for any Grade 3 hemorrhagic events that do not improve; withhold therapy for Grade 3 hemorrhagic events; if improved, resume at next lower dose level

    Venous thromboembolism can occur when used in combination with trametinib

    Serious febrile reactions and fever of any severity complicated by hypotension, rigors or chills reported

    Hyperglycemia reported; monitor serum glucose levels in patients with pre-existing diabetes or hyperglycemia; initiate or optimize anti-hyperglycemic medications as clinically indicated

    Contains a sulfonamide moiety which increases the risk of hemolytic anemia in patients with G6PD deficiency

    Based on its mechanism of action, dabrafenib can cause fetal harm; advise females of reproductive potential of potential risk to a fetus

    Verify pregnancy status in females of reproductive potential prior to initiating therapy

    Based on data from animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women

    Dabrafenib was teratogenic and embryotoxic in rats at doses three times greater than the human exposure

    Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production

    Adults

    150 mg PO twice daily.

    Geriatric

    150 mg PO twice daily.

    Adolescents

    Less than 26 kg: Safety and efficacy have not been established.
    26 to 37 kg: 75 mg PO twice daily.
    38 to 50 kg: 100 mg PO twice daily.
    51 kg or more: 150 mg PO twice daily.

    Children

    Ages 5 or younger:
    Safety and efficacy have not been established.
    Ages 6 to 12:
    Less than 26 kg: Safety and efficacy have not been established.
    26 to 37 kg: 75 mg PO twice daily.
    38 to 50 kg: 100 mg PO twice daily.
    51 kg or more: 150 mg PO twice daily.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Dabrafenib

    capsule

    • 50mg
    • 75mg