DABRAFENIB
Background and Date of Approval
Dabrafenib is the active ingredient in this medication. It is indicated for treating melanoma that cannot be surgically removed or has metastasised to other sites in the body. It also reduces the risk of melanoma recurrence following surgical resection. Dabrafenib is used to treat non-small cell lung cancer (NSCLC). Treatment with dabrafenib is restricted to NSCLC and melanomas that harbour abnormal BRAF gene mutations. In cancer, malignant cells proliferate uncontrollably and abnormally. The U.S. Food and Drug Administration approved dabrafenib on 29 May 2013 for unresectable or metastatic melanoma with BRAF V600E mutation. Inform your doctor if you have hepatic impairment, renal impairment, cardiac problems, ocular disorders, respiratory difficulties, gastrointestinal disorders, or history of another malignancy prior to commencing this medication. This medication is not recommended for adolescents and children below 18 years of age.
Uses
Dabrafenib treats unresectable or metastatic melanoma with a BRAF V600E mutation. It is usually used in combination with another medication, trametinib, to increase the effectiveness of the treatment. It is also used in the treatment of non-small cell lung cancer.
How is it administered?
Dabrafenib is usually taken orally, in the form of a capsule, once or twice a day, with or without food. The dose and frequency of dabrafenib depend on several factors, such as the individual's age, weight, overall health, and the type and stage of the cancer being treated. It should be swallowed whole with a full glass of water and should not be opened, crushed, or chewed. If a dose is missed, it should be taken as soon as possible unless it's almost time for the next scheduled dose, in which case the missed dose should be skipped, and the regular dosing schedule resumed. Do not double the dose to make up for missed doses.
Side Effects
Like any other medication, Dabrafenib can cause side effects in some people. Common side effects include fever, fatigue, headache, joint pain, skin rash, and nausea. These side effects are usually mild to moderate in severity and can be managed with supportive care and dose adjustments. In addition to these common side effects, it can also cause serious side effects in some people, such as high blood pressure, heart problems, bleeding, blood clots, eye problems, liver damage, and lung problems. These side effects are rare but can be life-threatening if left untreated.
Warnings
Dabrafenib can increase the risk of developing new skin cancers or precancerous skin lesions when the skin comes in contact with excessive sun exposure treatment. It can increase the risk of bleeding, especially in patients taking blood thinners or other medications that affect blood clotting. This medication also increases the risk of heart problems, including heart failure, decreased left ventricular ejection fraction, and QT prolongation. Sometimes it can cause liver damage, including hepatotoxicity and liver failure, and also causes photosensitivity (increasing the risk of sunburn or skin rash). In rare cases, this medication result in eye problems, including uveitis and retinal detachment. It can cause renal impairment or kidney damage in some people.
Precautions
Several precautions should be taken when using Dabrafenib. First, this medication should not be used in patients who are allergic to it or any of its components. While taking these medications, patients should use sun protection while going out to reduce the risk of photosensitivity and secondary skin cancer. Before starting the treatment, you should tell a doctor if you are on a blood thinner, a heart patient, liver disease, or a kidney problem, so the healthcare provider will do regular monitoring and dose adjustment if required. Patients who are pregnant or breastfeeding should not use this medication. Women of reproductive age should use effective contraception while taking this medication to avoid contraception.
Word of Advice
Patients receiving Dabrafenib should maintain regular communication with their healthcare provider and report any concerns or side effects promptly. Pregnancy should be avoided during treatment. Effective birth control is necessary during treatment and for at least 2 weeks after the last dose. Sun protection measures are recommended to reduce the risk of secondary skin cancer. Physical and emotional self-care during treatment is important, with support from family and healthcare professionals as needed. A healthy, balanced diet during treatment supports overall health and well-being. Active engagement in treatment monitoring and management helps ensure optimal outcomes and reduces potential risks or complications.
References
Novartis Europharm Limited, Electronic medicines compendium (emc), [Revised on Jan 2021] [ Accessed on 19 April, 2023], https://www.medicines.org.uk/emc/files/pil.5190.pdf GlaxoSmithKline, US Food and Drug Administration, [Revised on Jan 2014] [ Accessed on 19 April, 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf Enrico Tiacci et al; Safety and efficacy of the BRAF inhibitor dabrafenib in relapsed or refractory hairy cell leukemia: a pilot phase-2 clinical trial; Leukemia; Published on 17/03/2021; [Accessed on 19 April, 2023] https://www.nature.com/articles/s41375-021-01210-8.pdf
Frequently Asked Questions
Can dabrafenib be used to treat other types of cancer besides melanoma?
Dabrafenib is currently only approved for the treatment of melanoma and has not been approved for other types of cancer.it is also used in the treatment of non-small cell lung carcinoma.
Can dabrafenib be used in combination with other medications for melanoma treatment?
Yes, dabrafenib is often used with trametinib for treating melanoma.
How long do patients typically take dabrafenib?
The dabrafenib treatment duration can vary depending on the individual patient and their response to treatment. Some patients may take dabrafenib for several months, while others may take it for several years.
Can dabrafenib be taken with food?
Dabrafenib should be taken at least one hour before or two hours after a meal, as food can affect the absorption of the medication.
Can dabrafenib cause hair loss?
Hair loss is not a common side effect of dabrafenib, but it can occur in some patients. Hair growth becomes normal after discontinuing this medication.
Can dabrafenib be used in pediatric patients?
Dabrafenib is not currently approved for use in pediatric patients, and its safety and effectiveness have not been established in this population.