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dabrafenib

Generic Name: dabrafenib (da bRAF e nib)
Brand Name: Tafinlar

What is dabrafenib?

Dabrafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Dabrafenib is used to treat a certain type of metastatic melanoma (skin cancer that has spread to other parts of the body). Dabrafenib is sometimes used with another medicine called trametinib (Mekinist).

Dabrafenib is also used with trametinib to treat a certain type of non-small cell lung cancer that has spread to other parts of the body.

Dabrafenib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dabrafenib?

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms.

What should I discuss with my healthcare provider before taking dabrafenib?

You should not use dabrafenib if you are allergic to it.

To make sure dabrafenib is safe for you, tell your doctor if you have:

  • heart disease;

  • liver or kidney disease;

  • diabetes (dabrafenib may raise your blood sugar);

  • eye problems (especially a problem with your retina); or

  • a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

Do not use dabrafenib if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use effective birth control to prevent pregnancy while you are using this medicine.

  • If you use dabrafenib alone: Keep using birth control for at least 2 weeks after your last dose.

  • If you use dabrafenib and trametinib together: Keep using birth control for at least 4 months after your last dose of these two medicines.

Dabrafenib can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking dabrafenib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because dabrafenib may harm the baby if a pregnancy does occur.

It is not known whether dabrafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose (or 4 months after your last dose of dabrafenib with trametinib).

How should I take dabrafenib?

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with dabrafenib.

Dabrafenib is usually taken twice daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take dabrafenib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush, chew, break, or open a dabrafenib capsule. Swallow it whole.

If you need surgery, dental work, or a medical procedure, tell the doctor ahead of time that you are using dabrafenib.

Your doctor will need to check your skin every 2 months while you are using dabrafenib, and for up to 6 months after your treatment ends.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 6 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking dabrafenib?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Dabrafenib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take dabrafenib and trametinib together. Call your doctor at once if you have:

  • fever, chills, weakness, feeling light-headed or short of breath;

  • pale or yellowed skin, dark colored urine;

  • eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

  • severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor;

  • signs of bleeding--weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • signs of a heart problem--shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Common side effects may include:

  • headache, joint pain;

  • fever, chills, tiredness;

  • dry skin, rash;

  • swelling in the legs, arms, and face;

  • nausea, vomiting, diarrhea, loss of appetite;

  • cough, trouble breathing; or

  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Dabrafenib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

Usual Adult Dose for Melanoma - Metastatic:

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

What other drugs will affect dabrafenib?

Other drugs may interact with dabrafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about dabrafenib.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01.

Date modified: December 03, 2017
Last reviewed: August 11, 2017

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