Tafinlar ®

Posted on July 16th, 2013 by

Class: Biological Therapy

Generic Name: dabrafenib

Trade Name: Tafinlar ®

How is this drug used? Tafinlar is used for the treatment of melanoma that has metastasized or cannot surgically removed and that tests positive for a specific mutation (V600E) in the BRAF gene.

What is the mechanism of action? Approximately half of all late-stage melanomas have a mutation known as V600E in the BRAF gene. Tafinlar inhibits the protein produced by this mutated gene and helps to control cell growth.

How is Tafinlar given (administered)? Tafinlar is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Tafinlar. Patients may undergo periodic blood tests, skin examinations, and other procedures in order to assess side effects and response to therapy.

What are the most common side effects of treatment with Tafinlar?

  • Skin thickening
  • Headache
  • Joint pain
  • Warts
  • Hair loss
  • Redness, swelling, or peeling of the hands or feet

    What are some of the less common but potentially serious side effects of Tafinlar?

    Tafinlar may cause a type of skin cancer known as cutaneous squamous cell carcinoma. This type of skin cancer usually does not spread to other parts of the body, but it can. Patients should notify their physician if they notice a new wart, a skin sore or reddish bump that bleeds or does not heal, or a change in the size or appearance of a mole.

    Other potentially serious side effects include severe fever, blood sugar problems, and eye problems.

    This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

    Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

    What can patients do to help alleviate or prevent discomfort and side effects?

    • Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

    Are there any special precautions patients should be aware of before starting treatment?

    • Patients should inform their physician about all medical conditions, including liver or kidney problems, diabetes, deficiency of an enzyme known as glucose-6-phosphate dehydrogenase (G6PD), and any plans to have surgical, dental, or other medical procedures.
    • Patients should inform their physician of any other medication or supplement they are taking, whether prescription or over-the-counter.
    • Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Tafinlar may harm an unborn baby. Tafinlar may also reduce the effectiveness of hormonal birth control methods such as birth control pills, patches, or injections. In men, Tafinlar may decrease sperm count.

    When should patients notify their physician?

    Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you notice signs of a new skin cancer (such as a new wart, a skin sore or reddish bump that bleeds or does not heal, and a change in the size or color of a mole); fever; signs of blood sugar problems (such as increased thirst, an increase in urination, or a change in the way your breath smells); or signs of eye problems (such as eye pain, swelling, or redness, or changes in vision).

    What is a package insert?

    A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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