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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Frequently Asked Questions

South Delhi Pharma is a consultancy company which facilitates patients, hospitals, clinicians and researchers in accessing products which are not available or approved in their home country. IPN also helps companies in designing and implementing PAP (Patient Assistance Plan) or Patient Centric Programs, CROs in accessing products for clinical trials. More Details

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Medicines once shipped will not be taken back. We will assist you with the Export Invoice and tracking details of your order. International orders might be subject to import taxes/duties. For information, please contact your local customs authority. Any such taxes are the responsibility of the parcel recipient and are not paid by us.

There are some medicines which have been approved recently in USA or Europe but not yet approved in India or any other countries are not permitted to be imported or marketed commercially. However, they may be required for the treatment of patients to save their lives who have exhausted all other available treatment options in their country. Named – Patient Program is to facilitate import of such medicines for personal use. There is a provision under the Indian Drugs and Cosmetics Rules, 1945, that permits the patient to import these medicine in small quantity. Similar regulatory provision also exist in other countries. We assist patient in preparing legal documents for import and connecting them with authorized suppliers in USA and Europe to secure genuine products.

A generic drug is a drug defined as “a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics, and intended use”. There are Indian companies which manufacture and market these generic medicines after getting approval from Regulatory Authority of the country. These generic medicines contain the same active ingredients as the original formulation and are identical or within an acceptable bioequivalent range to the Innovator drug counterpart with respect to pharmacokinetic and pharmaco-dynamic properties. By extension, therefore, generics are considered identical in dose, strength, route of administration, safety, efficacy, and intended use. They are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug. When generic products become available, the market competition often leads to substantially lower prices and thereby make is affordable for large number of needy patients.

It usually takes 8-9 working days after dispatch to reach medicine at outside India locations. Additional delays may occur due to heavy load on postal services and customs.

We advise to transfer money only through Interbank Transfer Modalities;

  • Online Net-banking for within India transfer.
  • International Wire Transfer (SWIFT) from outside India.
  • Cash on Delivery within India.

Cash on Delivery (COD) option is only available if the medicine is purchased and delivered in India. Preferred locations within India for COD facilities are within Municipal limits of New Delhi & NCR, Mumbai, Bangalore, Kolkata, Chennai & Hyderabad

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