Generic Name: dabrafenib (da-BRAF-e-nib)
Brand Name: Tafinlar
Dabrafenib is used for:
Treating certain types of skin cancer. 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.
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 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
Some MEDICINES MAY INTERACT with dabrafenib. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Atazanavir, boceprevir, clarithromycin, cobicistat, gemfibrozil, indinavir, itraconazole, ketoconazole, mifepristone, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole because they may increase the risk of dabrafenib's side effects
- Carbamazepine, dexamethasone, enzalutamide, H2 receptor antagonists (eg, ranitidine), hydantoins (eg, phenytoin), phenobarbital, primidone, 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.
- 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 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 a certain other type of skin cancer. The risk may be greater in patients with chronic sun exposure or with a history of skin cancer. Contact your doctor right away if you experience 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.
- Dabrafenib may cause a fever. 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 form of birth control while taking dabrafenib and for at least 4 months after stopping it. 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 4 weeks after you stop taking it. 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; constipation; cough; hair loss; headache; joint or muscle pain; nose or throat irritation; thickening of the skin.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); eye pain, swelling, or redness; 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; vision changes (eg, blurred vision, sensitivity to light).
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.
- 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 healthcare provider for complete information about the risks and benefits of using dabrafenib.
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.