TreatmentSkin Cancer,Melanoma,BRAF V600E solid tumors
ManufacturerDaxiong Pharmaceuticals, Vt Laos
Dabrafenib, sold under the brand name Dabrafedx by Daxiong Tafinlar & Rafinlar both by Novartis among others, is a medication for the treatment of cancers associated with a mutated version of the gene BRAF. Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth. Dabrafenib has clinical activity with a manageable safety profile in clinical trials of phase 1 and 2 in patients with BRAF (V600)-mutated metastatic melanoma.
The US Food and Drug Administration initially approved dabrafenib as a single agent treatment for patients with BRAF V600E mutation-positive advanced melanoma on May 29, 2013.Dabrafenib was approved for use in the European Union in August 2013.
Clinical trial data demonstrated that resistance to dabrafenib and other BRAF inhibitors occurs within six to seven months.To overcome this resistance, the BRAF inhibitor dabrafenib was combined with the MEK inhibitor trametinib. On January 8, 2014, the FDA approved this combination of dabrafenib and trametinib for BRAF V600E/K-mutant metastatic melanoma. On May 1, 2018, the FDA approved the combination dabrafenib/trametinib as an adjuvant treatment for BRAF V600E-mutated, stage III melanoma after surgical resection based on the results of the COMBI-AD phase 3 study, making it the first oral chemotherapy regimen that prevents cancer relapse for node positive, BRAF-mutated melanoma.
In April 2017, the European Union approved the combination of dabrafenib with trametinib for BRAF V600-positive advanced or metastatic non small-cell lung cancer (NSCLC).
Why is this medication prescribed?
Dabrafenib is used alone or in combination with trametinib (Mekinist) to treat a certain types of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. It is also used along with trametinib to treat and prevent the return of a certain type of melanoma after surgery to remove it and any affected lymph nodes. Dabrafenib is also used in combination with trametinib to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. It is also used to treat a certain type of thyroid cancer that has spread to nearby tissues or to other parts of the body that has not responded to previous treatment(s). Dabrafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
How should this medicine be used?
Dabrafenib comes as a capsule to take by mouth. It is usually taken twice a day on an empty stomach, 1 hour before or 2 hours after a meal. Take dabrafenib about 12 hours apart at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dabrafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking dabrafenib without talking to your doctor.
Swallow the capsules whole; do not open, break, or crush them.
Your doctor may adjust your dose or temporarily or permanently stop your treatment depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dabrafenib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.