Dabrafenib

Generic Name: dabrafenib (da-BRAF-e-nib)
Brand Name: Tafinlar

Dabrafenib is used for:

Treating certain types of skin cancer (melanoma). It may be used alone or in combination with trametinib. It may also be used for other conditions as determined by your doctor.

Dabrafenib is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use dabrafenib if:

  • you are allergic to any ingredient in dabrafenib

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using dabrafenib:

Some medical conditions may interact with dabrafenib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of bleeding problems or blood clots
  • if you have heart problems (eg, heart failure; fast, slow, or irregular heartbeat), high blood sugar or diabetes, liver or kidney problems, eye or vision problems, or glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • if you have skin problems or you have chronic sun exposure
  • if you plan to have surgery or dental or other medical procedures

Some MEDICINES MAY INTERACT with dabrafenib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Clarithromycin, gemfibrozil, ketoconazole, nefazodone, or ritonavir because they may increase the risk of dabrafenib's side effects
  • Carbamazepine, H2 blockers (eg, ranitidine), hydantoins (eg, phenytoin), phenobarbital, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), or St. John's wort because they may decrease dabrafenib's effectiveness
  • Dexamethasone, hormonal contraceptives (eg, birth control pills), midazolam, or warfarin because their effectiveness may be decreased by dabrafenib

This may not be a complete list of all interactions that may occur. Ask your health care provider if dabrafenib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dabrafenib:

Use dabrafenib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dabrafenib comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get dabrafenib refilled.
  • Dabrafenib may be used along with trametinib, which also comes with a patient information sheet. Read it carefully.
  • Take dabrafenib by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
  • Swallow dabrafenib whole with a glass of water. Do not break, crush, open, or chew before swallowing.
  • Take dabrafenib in the morning and in the evening, about 12 hours apart, unless your doctor directs you otherwise.
  • If you are taking dabrafenib with trametinib, take trametinib once a day at the same time each day with either the morning or evening dose of dabrafenib.
  • If you take an antacid, talk with your doctor or pharmacist about how to take it with dabrafenib.
  • Continue to take dabrafenib even if you feel well. Do not miss any doses.
  • If you miss a dose of dabrafenib, take it as soon as possible. If it is within 6 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use dabrafenib.

Important safety information:

  • Do NOT take more than the recommended dose, change your dose, or stop taking dabrafenib without checking with your doctor.
  • Tell your doctor or dentist that you take dabrafenib before you receive any medical or dental care, emergency care, or surgery.
  • Dabrafenib may increase the risk of developing other types of cancer, including another type of skin cancer. Contact your doctor right away if you experience any unusual symptoms, a new wart, a change in size or color of a mole, or any other skin changes (eg, skin sore or reddish bump that bleeds or does not heal). Your doctor will check your skin for changes every 2 months while you are taking dabrafenib and for up to 6 months after the last dose. Discuss with your doctor the benefits and risks of taking dabrafenib.
  • Severe and sometimes fatal bleeding has been reported in patients taking dabrafenib with trametinib. Contact your doctor right away if you have any unusual signs of bleeding, including coughing up blood or blood clots; dark, tarry, or bloody stools; unusual headache, dizziness, or weakness; or vomiting blood or vomit that looks like coffee grounds.
  • Serious and sometimes fatal blood clots in the arms, legs, or lungs have occurred in patients taking dabrafenib with trametinib. Contact your doctor right away if you develop chest pain; cool or pale arm or leg; pain or swelling in the arms or legs; sudden shortness of breath; or trouble breathing.
  • Serious and sometimes fatal heart problems, including heart failure, have been reported in patients using dabrafenib with trametinib. Your doctor will check your heart function before and during treatment with trametinib. Contact your doctor right away if you have fast heartbeat; shortness of breath; swelling in the hands, ankles, legs, or feet; or unusual light-headedness.
  • Dabrafenib can cause severe vision problems that can lead to loss of vision. Tell your doctor right away if you have any vision changes (eg, blurred vision; loss of vision; seeing color dots; seeing halos or blurred outline around objects; eye pain, swelling, or redness; sensitivity to light).
  • Dabrafenib may cause a fever, which may be serious. In some cases, dehydration, low blood pressure, dizziness, or kidney problems may happen with the fever. Tell your doctor right away if you have fever or chills, symptoms of dehydration (eg, dry mouth or eyes, sluggishness, unusual weakness), light-headedness, severe or persistent dizziness, fainting, or decreased urination.
  • Dabrafenib may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Dabrafenib may lower sperm counts. This may affect your ability to father a child. Contact your doctor to talk about family planning or if you have any questions or concerns.
  • Women who may become pregnant must use an effective nonhormonal form of birth control while taking dabrafenib and for at least 2 weeks after stopping it, or 4 months after stopping it when taking dabrafenib with trametinib. If you have questions about effective birth control, talk with your doctor.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using dabrafenib. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including eye exams and skin checks, may be performed while you use dabrafenib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dabrafenib should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Dabrafenib may cause harm to the fetus. Do not become pregnant while you are taking it and for at least 2 weeks after you stop taking it or for at least 4 months after you stop taking it with trametinib. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking dabrafenib while you are pregnant. It is not known if dabrafenib is found in breast milk. Do not breast-feed while taking dabrafenib.

Possible side effects of dabrafenib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cough; decreased appetite; diarrhea; hair loss; headache; joint or muscle pain; mild stomach pain; nausea; night sweats; nose or throat irritation; thickening of the skin; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); acne-like rash; bleeding from the gums, nose, eyes, rectum, or vagina; blood in the urine; red, swollen, blistered, or peeling skin; severe stomach or back pain with or without nausea or vomiting; tingling, pain, redness, or swelling of the palms of the hands and soles of the feet; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of dabrafenib:

Store dabrafenib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep dabrafenib out of the reach of children and away from pets.

General information:

  • If you have any questions about dabrafenib, please talk with your doctor, pharmacist, or other health care provider.
  • Dabrafenib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take dabrafenib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dabrafenib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dabrafenib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using dabrafenib.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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