dabrafenib mesilate at a glance
Medicine class
BRAF protein-kinase inhibitor
Biomarker required
The relevant BRAF V600 mutation must be confirmed before treatment.
Available forms
Hard capsules and dispersible tablets; these formulations are not interchangeable.
Food
Take without food, following the product-specific instructions.
What is dabrafenib mesilate used for?
Licensed uses require a confirmed tumour mutation and specialist supervision.
Adults: unresectable or metastatic melanoma with a BRAF V600 mutation, alone or with trametinib.
Adults: adjuvant treatment with trametinib after complete removal of Stage III melanoma with a BRAF V600 mutation.
Adults: advanced non-small cell lung cancer with a BRAF V600 mutation, with trametinib.
Children aged 1 year and older: BRAF V600E-mutated low-grade glioma requiring systemic treatment, with trametinib.
Children aged 1 year and older: BRAF V600E-mutated high-grade glioma previously treated with radiotherapy and/or chemotherapy, with trametinib.
How does dabrafenib mesilate work?
Some tumours contain an altered BRAF protein that continually activates a pathway promoting cell growth. Dabrafenib inhibits mutant BRAF signalling. When combined, trametinib blocks MEK further down the same pathway.
dabrafenib mesilate preparations and strengths
Capsule
Route: Oral
Strengths: 50 mg, 75 mg
Dispersible tablet
Route: Oral
Strengths: 10 mg
How to take dabrafenib mesilate
Follow the product-specific instructions from the specialist team. Capsules and dispersible tablets must not be substituted for each other.
Swallow capsules whole with water. Do not chew, open or mix them with food or liquids.
Take dabrafenib without food.
Disperse Finlee tablets in still drinking water using the supplied cup, stir gently and administer promptly.
Rinse the cup with more water and administer the residue. The suspension may be given through a compatible feeding tube when instructed by the clinical team.
dabrafenib mesilate side effects
Common or expected effects
- Fever, chills, tiredness or flu-like symptoms
- Headache or dizziness
- Nausea, vomiting, diarrhoea, constipation or abdominal discomfort
- Reduced appetite
- Rash, dry or itchy skin and other skin changes
- Joint, muscle or limb pain
- Cough
- Changes in blood counts or liver-test results, particularly in children receiving combination treatment
Get urgent medical advice
- Fever complicated by dehydration, low blood pressure or kidney problems
- Severe blistering, peeling or widespread rash, especially with mouth or eye sores
- Eye inflammation or retinal problems causing eye pain, light sensitivity or altered vision
- Blood clots or serious bleeding
- Heart dysfunction, including myocarditis
- Pancreatitis, colitis or gastrointestinal perforation
- Kidney inflammation or failure
- New skin cancers or other new malignancies
dabrafenib mesilate in pregnancy
Dabrafenib may harm an unborn baby and is generally avoided during pregnancy unless a specialist considers the potential benefit greater than the risk. It can reduce hormonal contraception's effectiveness, so discuss effective alternative contraception with the oncology team. Contact the specialist promptly if pregnancy occurs or is planned.
dabrafenib mesilate while breastfeeding
It is unknown whether dabrafenib passes into breast milk, and risk to a breastfed child cannot be excluded. A specialist should decide whether breastfeeding or treatment must be stopped, considering the benefits of each.
dabrafenib mesilate interactions
A full medication review is important because dabrafenib both affects and is affected by several drug-metabolising enzymes.
Rifampicin, carbamazepine, phenytoin, phenobarbital and St John’s wort
Strong enzyme induction may lower dabrafenib exposure and reduce its effect; use should generally be avoided.
Ketoconazole, itraconazole, clarithromycin, ritonavir and similar strong inhibitors
These may increase dabrafenib exposure and adverse effects, so alternatives or additional caution may be needed.
Common questions about dabrafenib mesilate
Answers are fully visible for fast scanning and source review.
Why is a genetic test needed?
Dabrafenib targets abnormal BRAF signalling and is not suitable for the selected licensed cancers unless the relevant BRAF V600 mutation is confirmed.
Is dabrafenib mesilate chemotherapy?
It is a targeted protein-kinase inhibitor rather than conventional cytotoxic chemotherapy.
Why is trametinib prescribed with it?
Dabrafenib inhibits BRAF and trametinib inhibits MEK, blocking different proteins in the same growth pathway.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.