This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Dabrafenib contains an active molecule named dabrafenib. It is used to treat skin cancer called melanoma which cannot be removed by surgery or has spread to other parts of the body. It also prevents melanoma from coming again after it has been removed from surgery. It is used to treat a kind of lung cancer called non-small cell lung cancer (NSCLC). It is only used to treat NSCLC and melanomas with abnormal BRAF genes. In cancer, cancer cells multiply uncontrolled and abnormally. 

Dabrafenib was approved by the U.S. Food and Drug Administration (FDA) on May 29, 2013, for treating unresectable or metastatic melanoma with a BRAF V600E mutation. Talk to your physician if you have any liver problems, kidney problems, heart problems, eye problems, breathing problems, gastrointestinal disorders, or have had a different type of cancer before taking this medication. It is not recommended for adolescents and children under the age of 18.

Mechanism of Action of undefined

The therapeutic effect of dabrafenib is inhibiting the BRAF protein, which plays a crucial role in the signaling pathway that leads to uncontrolled cell growth in cancer cells with the BRAF mutation. By blocking the activity of the BRAF protein, it can slow down or stop the growth and spread of cancer cells, leading to the shrinkage of tumors and improving overall health.

Uses of undefined

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.

undefined Drug administaration and Dosage available

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.

Warnings, Precautions and Side Effects of undefined

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.

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.

Word Of Advice

If you are receiving Dabrafenib, it's important to be proactive in managing your treatment and monitoring your symptoms. Keep communication with your healthcare provider and report any concerns or side effects as soon as possible. Avoid getting pregnant and breastfeeding during treatment. Use effective birth control during the treatment and at least 2 weeks after the last dose. Use sun protection to avoid the chances of secondary cancer of the skin. Take steps to care for yourself physically and emotionally during treatment, and seek support from loved ones and professionals as needed. Maintain a healthy and balanced diet during treatment to support your overall health and well-being. Being informed and engaged in your treatment can help ensure the best possible outcomes and manage potential risks or complications.

Frequently Asked Question

References

  1. 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
  2. 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
  3. 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

Disclaimer

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.