RAFINLAR 75 mg
Dabrafenib
What it does
Dabrafenib is a medicine used to treat certain types of cancer by targeting specific mutations in cancer cells.
Commonly used for: melanoma (skin cancer), non-small cell lung cancer (NSCLC), anaplastic thyroid cancer
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Sourcing - Kenya onlyRegistration & product details
Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:20:27 · updated 2026-09-23 04:11:38
Drug Interactions
119Severe (27)
Anti-Androgens - decreases exposure
Dabrafenib is predicted to decrease the exposure to anti-androgens (darolutamide). Avoid.
Antifungals,azoles - decreases exposure
Dabrafenib is predicted to decrease the exposure to antifungals, azoles (isavuconazole). Avoid.
Antipsychotics, Second Generation - decreases exposure
Dabrafenib is predicted to decrease the exposure to antipsychotics, second generation (cariprazine). Avoid.
Avapritinib - decreases exposure
Dabrafenib is predicted to decrease the exposure to avapritinib. Avoid.
Bedaquiline - decreases exposure
Dabrafenib is predicted to decrease the exposure to bedaquiline. Avoid.
Moderate (21)
Amlodipine - decreases exposure
Dabrafenib is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.
Benzodiazepines - decreases exposure
Dabrafenib decreases the exposure to benzodiazepines (midazolam). Monitor and adjust dose.
Calcium Channel Blockers - decreases exposure
Dabrafenib is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.
Dabrafenib - increases exposure
Cobicistat is predicted to increase the exposure to dabrafenib. Use with caution or avoid.
Dabrafenib - increases exposure
Idelalisib is predicted to increase the exposure to dabrafenib. Use with caution or avoid.
Unknown (71)
Acalabrutinib - decreases exposure
Dabrafenib is predicted to decrease the exposure to acalabrutinib.
Atorvastatin - decreases exposure
Dabrafenib is predicted to decrease the exposure to statins (atorvastatin, simvastatin).
Avacopan - decreases exposure
Dabrafenibispredictedtodecreasetheexposuretoavacopan. rTheoretical
Axitinib - decreases exposure
Dabrafenib is predicted to decrease the exposure to axitinib.
Bosutinib - decreases exposure
Dabrafenibispredictedtodecreasetheexposuretobosutinib. Avoid.rStudy
Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact
About this medicine
Dabrafenib is a medicine used to treat certain types of cancer by targeting specific mutations in cancer cells.
What it treats
- melanoma (skin cancer)
- non-small cell lung cancer (NSCLC)
- anaplastic thyroid cancer
How it works
It works by blocking a protein that helps cancer cells grow, which can slow down or stop the cancer from spreading.
Who it's for
Dabrafenib is for adults and children with specific types of cancer that have certain genetic changes.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Dabrafenib
BNF-referencedDabrafenib is a targeted therapy agent classified as a BRAF kinase inhibitor, primarily used in the treatment of certain types of malignancies characterized by BRAF V600 mutations, such as melanoma and non-small cell lung cancer. By selectively inhibiting the BRAF protein, dabrafenib disrupts the signaling pathways that lead to uncontrolled cell proliferation, ultimately aiding in the management of these cancers.
Indications
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Advanced non-small cell lung cancer with a BRAF V600 mutation (in combination with trametinib)
- Adjuvant treatment of stage III melanoma with a BRAF V600 mutation following complete resection (in combination with trametinib)
Dosage
Adults: 150 mg orally every 12 hours. For dose
Mechanism of action
Dabrafenib functions as a competitive and selective BRAF inhibitor by binding to the ATP pocket of the BRAF kinase. It has a particular affinity for mutant forms of BRAF, including BRAF V600E, V600K, and V600D. This inhibition affects the RAS/RAF/MEK/ERK signaling pathway, which is crucial for cell cycle progression and proliferation. Mutations in BRAF are commonly implicated in various cancers, making dabrafenib a targeted therapeutic option for tumors harboring such mutations.
Pharmacodynamics
As a kinase inhibitor, dabrafenib specifically targets the BRAF V600E mutation across several cancer types. It operates by inhibiting different effectors of the RAS/RAF/MEK/ERK pathway compared to other agents like trametinib, thus enhancing therapeutic response while reducing the risk of resistance and cumulative toxicity. Clinical studies have demonstrated significant efficacy in improving relapse-free survival rates in patients with BRAF V600 mutation-positive melanoma, particularly when combined with trametinib.
Pharmacokinetics
Dabrafenib exhibits variable pharmacokinetics with a bioavailability of approximately 95% when taken orally. It is extensively metabolized in the liver, primarily via CYP3A4 and CYP2C8 enzymes, and has a plasma half-life of about 8 hours. The drug is eliminated mainly through feces, with minimal renal excretion. Patients may require dose adjustments based on hepatic function and potential drug interactions.
Contra-indications
- BRAF wild-type melanoma
- BRAF wild-type non-small cell lung cancer
Adverse effects
- Alopecia
- Decreased appetite
- Arthralgia
- Asthenia
- Chills
- Constipation
- Cough
- Diarrhoea
- Fever
- Headache
- Hyperglycaemia
- Dizziness
- Hyperhidrosis
- Hyponatraemia
- Hypotension
- Leucopenia
- Muscle spasms
- Myocarditis
- Neutropenia
- Night sweats
Interactions
- Dabrafenib + darolutamide: Severe (decreases exposure)
- Dabrafenib + cariprazine: Severe (decreases exposure)
- Dabrafenib + avapritinib: Severe (decreases exposure)
- Dabrafenib + bedaquiline: Severe (decreases exposure)
- Dabrafenib + cobimetinib: Severe (decreases exposure)
- Dabrafenib + anti-androgens: Severe (decreases exposure)
- Dabrafenib + antifungals, azoles: Severe (decreases exposure)
- Dabrafenib + isavuconazole: Severe (decreases exposure)
- Dabrafenib + antipsychotics, second-generation: Severe (decreases exposure)
- Dabrafenib + elvitegravir: Severe (decreases concentration)
Precautions
- Monitor full blood count as clinically indicated
- Monitor for ophthalmologic reactions including uveitis, iridocyclitis and iritis
- Monitor serum creatinine
- Counsel patients on the effects on driving and performance of skilled tasks due to increased risk of ocular adverse reactions
- Missed doses: 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
Pregnancy
There is insufficient data on the use of dabrafenib in pregnant women. The potential risks should be discussed with the
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Molecular reference: Dabrafenib
PubChem CID 44462760Molecular formula: C23H20F3N5O2S2
Mechanism of action
Dabrafenib is a competitive and selective BRAF inhibitor by binding to its ATP pocket. Although dabrafenib can inhibit wild-type BRAF, it has a higher affinity for mutant forms of BRAF, including BRAF V600E, BRAF V600K, and BRAF V600D. BRAF is a serine/threonine protein kinase and is involved in activating the RAS/RAF/MEK/ERK or MAPK pathway, a pathway that is implicated in cell cycle progression, cell proliferation, and arresting apoptosis.Therefore, constitutive active mutation of BRAF such as BRAF V600E is frequently observed in many types of cancer, including melanoma, lung cancer, and colon cancer.
Pharmacodynamics
Dabrafenib is a kinase inhibitor that is mainly used to target BRAF V600E mutation in multiple types of cancer. Although dabrafenib and [trametinib] both inhibit the RAS/RAF/MEK/ERK pathway, they inhibit different effectors of the pathway, thus increasing response rate and mitigating resistance without cumulative toxicity. The melanoma approval for use with [trametinib] is based on results from COMBI-AD, a Phase III study of 870 patients with Stage III BRAF V600E/K mutation-positive melanoma treated with dabrafenib + trametinib after complete surgical resection. Patients received doses of dabrafenib (150 mg BID) + trametinib (2 mg QD) combination (n = 438) or matching placebos (n = 432). After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met. In the case of thyroid cancer, Dabrafenib plus Trametinib is the first regimen demonstrated to have potent clinical activity in BRAF V600E–mutated anaplastic thyroid cancer and is well tolerated. These findings represent a meaningful therapeutic advance for this orphan disease.
Biological pathways
Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.