Drug Action
Encorafenib inhibits the mitogen-activated protein kinase (MAPK) pathway, specifically BRAF kinase, thereby inhibiting BRAF V600 mutation-positive cell growth.
PDF page 1054
Loading InternPractice…
Drug reference
Encorafenib inhibits the mitogen-activated protein kinase (MAPK) pathway, specifically BRAF kinase, thereby inhibiting BRAF V600 mutation-positive cell growth.
PDF page 1054
Unresectable or metastatic melanoma with a BRAF V600 mutation (in combination with binimetinib) (specialist use only) ▶BY MOUTH ▶Adult: 450 mg once daily, for dose adjustments due to side-effects, consult product literature
PDF page 1054
BRAF wild-type malignant melanoma
PDF page 1054
Prior or concurrent cancer associated with RAS mutation. risk factors for QT-interval prolongation
PDF page 1054
NICE decisions ▶Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma (February 2019) NICE TA562 Encorafenib (Braftovi ®) with binimetinib is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation- positive melanoma in adults. It is recommended only if the manufacturer provides encorafenib according to the commercial arrangements. www.nice.org.uk/guidance/ta562 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2238 The Scottish Medicines Consortium has advised (February 2020) that encorafenib (Braftovi ®) is accepted for use within NHS Scotland in combination with binimetinib for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
PDF page 1055
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
PDF page 1054
→Appendix 1: encorafenib
PDF page 1054
▶Common or very common Alopecia. anaemia. angioedema . appetite decreased. arrhythmias. arthralgia. arthritis. constipation. detachment of retinal pigment epithelium. diarrhoea. dizziness. embolism and thrombosis. eye inflammation. facial paralysis. fatigue. fever. fluid retention. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headache. heart failure. hypersensitivity. hypersensitivity vasculitis. hypertension . insomnia. intracranial haemorrhage. left ventricular dysfunction. lip squamous cell carcinoma. muscle complaints. muscle weakness. myopathy. nausea. neoplasms. nerve disorders. oedema. pain. panniculitis. paresis. photosensitivity reaction. renal impairment. skin reactions. taste altered. ulcerative colitis. vision disorders . vomiting ▶Uncommon Pancreatitis ▶Frequency not known QT interval prolongation
PDF page 1054
Manufacturer advises women of child-bearing potential should use effective contraception during and for at least one month after stopping treatment; additional barrier method recommended in women using hormonal contraceptives.
PDF page 1054
Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
PDF page 1054
Manufacturer advises avoid—no information available.
PDF page 1054
Manufacturer advises caution in mild impairment (increased exposure); avoid in moderate or severe impairment (no information available). Dose adjustments Manufacturer advises dose reduction to 300 mg once daily in mild impairment.
PDF page 1054
Manufacturer advises caution in severe impairment (no information available).
PDF page 1054
▶Manufacturer advises assess for cutaneous squamous cell carcinoma and new primary melanoma before treatment, every 2 months during treatment, and for up to 6 months after discontinuation; assess for non-cutaneous malignancy and monitor full blood count before, during, and after treatment discontinuation as clinically indicated—consult product literature. ▶Manufacturer advises monitor liver function before treatment, at least monthly during the first 6 months, and thereafter as clinically indicated. ▶Manufacturer advises assess ECG before treatment, one month after starting treatment, then every 3 months or more frequently as clinically indicated. ▶Manufacturer advises monitor blood creatinine levels as clinically indicated. ▶Manufacturer advises monitor for ophthalmologic reactions including uveitis, iridocyclitis, and iritis.
PDF pages 1054, 1055
There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 3, 25 ▶Braftovi (Pierre Fabre Ltd) A Encorafenib 50 mg Braftovi 50mg capsules | 28 capsule P £622.22 (Hospital only) Encorafenib 75 mg Braftovi 75mg capsules | 42 capsule P £1,400.00 (Hospital only)
PDF page 1055
Manufacturer advises patients should be informed to immediately report new skin lesions—risk of cutaneous squamous cell carcinoma and new primary melanoma. Missed doses Manufacturer advises if a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of visual disturbances.
PDF page 1055
450 mg once daily, for dose adjustments due to
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1054