Drug Action
Dabrafenib is a BRAF kinase inhibitor, which inhibits BRAF V600 mutation-positive melanoma cell growth.
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Drug reference
Dabrafenib is a BRAF kinase inhibitor, which inhibits BRAF V600 mutation-positive melanoma cell growth.
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Unresectable or metastatic melanoma with a BRAF V600 mutation (as monotherapy or in combination with trametinib) (specialist use only) | Advanced non-small cell lung cancer with a BRAF V600 mutation (in combination with trametinib) (specialist use only) ▶BY MOUTH Immune system and malignant disease ▶Adult: 150 mg every 12 hours, for dose adjustments due to side-effects, consult product literature Adjuvant treatment of stage III melanoma with a BRAF V600 mutation following complete resection (in combination with trametinib) (specialist use only) ▶BY MOUTH ▶Adult: 150 mg every 12 hours for 12 months, for dose adjustments due to side-effects, consult product literature
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BRAF wild-type melanoma. BRAF wild-type non-small cell lung cancer
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Elderly (more frequent dose adjustments may be required). prior or concurrent cancer associated with RAS mutations—risk of secondary or recurrent malignancy
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NICE decisions ▶Dabrafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma (October 2014) NICE TA321 Dabrafenib (Tafinlar ®) is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma only if the manufacturer provides dabrafenib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta321 ▶Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (June 2016) NICE TA396 Trametinib (Mekinist ®) in combination with dabrafenib (Tafinlar ®) is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation only when the manufacturer provides trametinib and dabrafenib with the discounts agreed in the patient access schemes. www.nice.org.uk/guidance/ta396 ▶Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma (October 2018) NICE TA544 Dabrafenib (Tafinlar ®) with trametinib (Mekinist ®) is recommended, within its marketing authorisation, as an option for the adjuvant treatment of resected stage III BRAF V600 mutation-positive melanoma in adults. It is recommended only if the manufacturer provides dabrafenib and trametinib with the discounts agreed in the commercial arrangements. www.nice.org.uk/guidance/ta544 Scottish Medicines Consortium (SMC) decisions SMC No. 1023/15 The Scottish Medicines Consortium has advised (March 2015) that dabrafenib (Tafinlar ®) is accepted for restricted use within NHS Scotland, as monotherapy, for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in adults who have received no prior therapy. 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. SMC No. SMC2131 The Scottish Medicines Consortium has advised (February 2019) that dabrafenib (Tafinlar ®) is accepted for use within NHS Scotland in combination with trametinib for the adjuvant treatment of adults with stage III melanoma with a BRAF V600 mutation, following complete resection. 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.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: dabrafenib
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▶Common or very common Alopecia. appetite decreased. arthralgia. asthenia. chills. constipation. cough. diarrhoea. fever. headache. hyperglycaemia. hypophosphataemia. influenza like illness. myalgia. nausea. neoplasms. pain in extremity. photosensitivity reaction. skin reactions. vomiting ▶Uncommon Nephritis. pancreatitis. panniculitis. renal impairment. uveitis SIDE-EFFECTS, FURTHER INFORMATION Additional side- effects reported when used in combination with trametinib include dizziness, hyperhidrosis, hyponatraemia, hypotension, leucopenia, muscle spasms, myocarditis, neutropenia, night sweats, and thrombocytopenia.
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Manufacturer advises women of child-bearing potential should use effective non-hormonal contraception during and for 4 weeks after stopping treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available.
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Manufacturer advises caution in moderate to severe impairment—no information available.
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Manufacturer advises caution in severe impairment—no information available.
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Manufacturer advises assess for cutaneous squamous cell carcinoma and new primary melanoma before treatment, monthly during treatment, and for 6 months after discontinuation or until initiation of alternative treatment; assess and monitor for non- cutaneous secondary or recurrent malignancy before, during, and for 6 months after discontinuation or until initiation of alternative treatment—consult product literature; monitor full blood count as clinically indicated; monitor for ophthalmologic reactions including uveitis, iridocyclitis and iritis; monitor serum creatinine.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 3, 23, 25 ▶Tafinlar (Novartis Pharmaceuticals UK Ltd) Dabrafenib (as Dabrafenib mesilate) 50 mg Tafinlar 50mg capsules | 28 capsule P £933.33 (Hospital only) Dabrafenib (as Dabrafenib mesilate) 75 mg Tafinlar 75mg capsules | 28 capsule P £1,400.00 (Hospital only)
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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 6 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 ocular Immune system and malignant disease adverse reactions.
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150 mg every 12 hours, for dose adjustments due
First-line fragment. Read the complete Indications and Dose section above.
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150 mg every 12 hours for 12 months, for dose
First-line fragment. Read the complete Indications and Dose section above.
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