1. Name of the medicinal product
Tafinlar® 50 mg hard capsules
Tafinlar® 75 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib.
Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule (capsule).
Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with 'GS TEW' and '50 mg'.
Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with 'GS LHF' and '75 mg'.
4. Clinical particulars
4.1 Therapeutic indications
Dabrafenib is indicated in monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see section 5.1).
4.2 Posology and method of administration
Treatment with dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
The efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma therefore dabrafenib should not be used in patients with BRAF wild-type melanoma (see sections 4.4 and 5.1).
Posology
The recommended dose of dabrafenib is 150 mg (two 75 mg capsules) twice daily (corresponding to a total daily dose of 300 mg). Dabrafenib should be taken at least one hour before, or at least 2 hours after a meal, and leaving an interval of approximately 12 hours between doses. Dabrafenib should be taken at similar times every day to increase patient compliance.
Duration of treatment
Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity (see Table 2).
Missed doses
If a dose is missed, it should not be taken if it is less than 6 hours until the next dose.
Dose modification
Two dabrafenib capsule strengths, 50 mg and 75 mg, are available to effectively manage dose modification requirements.
The management of adverse reactions may require treatment interruption, dose reduction, or treatment discontinuation (see Tables 1 and 2).
Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see section 4.4).
Therapy should be interrupted if the patient's temperature is ≥ 38.5°C. Patients should be eva luated for signs and symptoms of infection (see section 4.4).
Recommended dose level reductions and recommendations for dose modifications are provided in Table 1 and Table 2, respectively. Posology adjustments resulting in a dose lower than 50 mg twice daily are not recommended.
Table 1: Recommended dabrafenib dose level reductions
