New Delhi, India – 110 016

Rafinlar (Dabrafenib) Capsule

Generic brands for Dabrafenib Capsule Available in India

Brand Name Rafinlar
Generic Name Dabrafenib
Strength 50mg, 75mg
Manufacturer Novartis India Ltd

 

Description

Description

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

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 Dabrafenib

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 Dabrafenib

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.

Dabrafenib 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.

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News/Updates

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
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