Dabrafenib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat a certain kind of spreading skin cancer. Take it exactly as directed.
• This medicine may cause other types of skin cancer, serious fever, serious eye problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: dabrafenib, oral; Tafinlar

What is this medicine used for?

This medicine is taken by mouth alone or along with trametinib to treat a certain kind of spreading melanoma that is linked to an abnormal BRAF gene.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems or blood clots
• Eye problems
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Diabetes
• Heart problems
• Liver or kidney problems

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 2 weeks after you stop treatment with this medicine, or for 4 months after you stop treatment with this medicine along with trametinib. This medicine may cause hormonal birth control to be less effective. Talk with your healthcare provider about effective non-hormonal forms of birth control. Do not breast-feed while you are taking this medicine.

This medicine, along with trametinib, may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

Males: This medicine may cause lower sperm counts. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is usually taken in the morning and in the evening, about 12 hours apart. Take the medicine at least 1 hour before or at least 2 hours after a meal. Swallow the capsules whole with water. Do not crush or chew them.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 6 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Your healthcare provider may check your heart before your start treatment and regularly during treatment to see how this medicine affects you. You may also have blood tests regularly while you are receiving this medicine. Keep all appointments.

This medicine may cause different types of skin cancer. Your healthcare provider will check your skin regularly while you are taking this medicine, and for up to 6 months after you stop taking this medicine. Tell your healthcare provider about any skin changes.

This medicine may cause serious eye problems. Contact your healthcare provider if you have any eye pain, swelling, or redness, or any vision changes. You may need vision tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fever; severe dizziness or fainting; unexplained tiredness or weakness; unusual bruising or bleeding; coughing up blood; black or tarry stools; vomiting blood or vomit looks like coffee grounds; chest pain; severe cough, shortness of breath, or trouble breathing; frequent urination and constant thirst; decreased urination; unexplained swelling, especially in your feet, ankles, arms, or legs; pain or redness in your legs; fast or irregular heartbeat; pain, redness, swelling, peeling, or blisters on the palms of your hands or soles of your feet; mouth sores or blisters; eye swelling, pain, redness, light sensitivity, or vision changes; acne, new warts; mole or skin changes; yellowing of the eyes and skin; sores that don't heal.

Other: Mild nausea, vomiting, or stomach pain; tiredness; constipation; diarrhea; night sweats; decreased appetite; hair loss; joint and muscle pain; back pain; mild headache; sore throat; dry mouth; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antacids
• Antianxiety medicines such as alprazolam (Xanax), buspirone, and diazepam (Valium)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), dapsone, erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, pentamidine, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, trazodone, and trimipramine
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), axitinib (Inlyta), bosutinib (Bosulif), dasatinib (Sprycel), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), sorafenib (Nexavar), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Darifenacin (Enablex)
• Dexamethasone
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Eliglustat (Cerdelga)
• Everolimus (Afinitor, Zortress)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), eplerenone (Inspra), felodipine, losartan (Cozaar), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), procainamide, quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Midazolam (Versed)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), ondansetron (Zofran), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), meloxicam, and piroxicam (Feldene)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol/acetaminophen (Ultracet)
• Pasireotide (Signifor)
• Roflumilast (Daliresp)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Simeprevir (Olysio)
• Sleeping pills such as flurazepam, secobarbital (Seconal), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Tetrabenazine (Xenazine)
• Tolvaptan (Samsca)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.