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Encorafenib

    Brands

    DAE Class; Rx

    Common Brand Names; Braftovi

    • Antineoplastics, BRAF Kinase Inhibitor

    BRAF inhibitor
    Used for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation in combination with binimetinib, and for BRAF V600E mutated metastatic colorectal cancer in combination with cetuximab
    New primary cutaneous malignancies and QT prolongation have been reported

    Indicated in combination with binimetinib for unresectable or metastatic melanoma in patients with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

    Encorafenib is used for the treatment of malignant melanoma.

    For the treatment of colorectal cancer.

    None

    >10% (Melanoma)

    All grades

    • Fatigue (43%)
    • Nausea (41%)
    • Vomiting (30%)
    • Abdominal pain (28%)
    • Arthralgia (26%)
    • Myopathy (23%)
    • Hyperkeratosis (23%)
    • Constipation (22%)
    • Rash (22%)
    • Headache (22%)
    • Hemorrhage (19%)
    • Pyrexia (18%)
    • Dry skin (16%)
    • Dizziness (15%)
    • Alopecia (14%)
    • Pruritus (13%)
    • Peripheral neuropathy (12%)
    • Pain in extremity (11%)

    >10% (mCRC)

    All grades

    • Fatigue (51%)
    • Anemia (34%)
    • Nausea (34%)
    • Diarrhea (33%)
    • Dermatitis acneiform (32%)
    • Abdominal pain (30%)
    • Decreased appetite (27%)
    • Arthralgia (27%)
    • Rash (26%)
    • Lymphopenia (24%)
    • Vomiting (21%)
    • Headache (20%)
    • Hypomagnesemia (19%)
    • Hemorrhage (19%)
    • Peripheral neuropathy (19%)
    • Increased alkaline phosphatase (18%)
    • Pyrexia (17%)
    • Increased AST/ALT (15-17%)
    • Constipation (15%)
    • Myopathy (15%)
    • Melanocytic nevus (14%)
    • Pruritus (14%)
    • Increased aPTT (13%)
    • Insomnia (13%)
    • Dry skin (13%)
    • Hypokalemia (12%)
    • Hyponatremia (11%)

    1-10% (Melanoma)

    All grades

    • Facial paresis (<10%)
    • Pancreatitis (<10%)
    • Panniculitis (<10%)
    • Drug hypersensitivity (<10%)

    Grade 3 or 4

    • Abdominal pain (4%)
    • Pyrexia (4%)
    • Fatigue (3%)
    • Hemorrhage (3%)
    • Dizziness (3%)
    • Vomiting (2%)
    • Nausea (2%)
    • Headache (2%)
    • Pruritus (1%)
    • Rash (1%)
    • Hyperkeratosis (1%)
    • Peripheral neuropathy (1%)
    • Pain in extremity (1%)
    • Arthralgia (1%)

    1-10% (mCRC)

    All grades

    • Pancreatitis (<10%)
    • Pain in extremity (10%)

    Grade 3 or 4

    • Fatigue (7%)
    • Increased alkaline phosphatase (4%)
    • Abdominal pain (4%)
    • Hypokalemia (3%)
    • Diarrhea (2%)
    • Hyponatremia (2%)
    • Hemorrhage (2%)
    • Peripheral neuropathy (1%)
    • Increased AST (1%)
    • Dermatitis acneiform (1%)
    • Arthralgia (1%)
    • Myopathy (1%)
    • Decreased appetite (1%)
    • Vomiting (1%)
    • Nausea (1%)
    • Pyrexia (1%)

    Confirm evidence of BRAF V600E or V600K mutation prior to initiating treatment; in vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells, which are exposed to BRAF inhibitors; not indicated for wild-type BRAF melanoma

    Hemorrhage can occur; hemorrhagic events include GI, hemorrhoidal, rectal, and intracranial hemorrhage and hematochezia

    Uveitis (eg, iritis, iridocyclitis) reported; assess for visual symptoms at each visit; perform an ophthalmologic evaluation regularly and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings

    Dose-dependent QTc interval prolongation reported; monitor patients who already have or who are at significant risk of developing QTc prolongation (eg, patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure, those taking medications associated with QT prolongation); correct hypokalemia and hypomagnesemia prior to and during administration

    Based on its mechanism of action, fetal harm may occur when administered to a pregnant woman

    Grade 3 or 4 dermatologic reactions occurred in 21% of patients treated with encorafenib as a single agent compared with 2% of patients treated with encorafenib in combination with binimetinib

    Refer to the binimetinib or cetuximab prescribing information for additional risk information that applies to combination use treatment

    Pregnancy

    Based on its mechanism of action, fetal harm may occur when administered to pregnant women

    Lactation

    The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

    Adults

    450 mg/day PO.

    Geriatric

    450 mg/day PO.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Encorafenib 

    capsule

    • 50mg
    • 75mg