Dabrafenib (da-BRAF-e-nib)

Treats melanoma (skin cancer), non-small cell lung cancer (NSCLC), anaplastic thyroid cancer (ATC), solid tumors, and low-grade glioma (LGG).

Brand Name(s):

Tafinlar

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at least 1 hour before or 2 hours after a meal. Allow about 12 hours between each dose.
• Swallow the capsule whole. Do not open, crush, or break it.
• Tablet for suspension:
  • The tablet should be taken as an oral liquid only. Do not swallow whole, chew, or crush the tablet.
  • Add 5 mL of water for 1 to 4 tablets and 10 mL of water for 5 to 15 tablets in a cup.
  • Gently stir the mixture with the handle of a teaspoon until the tablets break apart.
  • Wait for 3 minutes or more until the tablets has broken up. The liquid should be cloudy white but may contain small pieces.
  • Swallow the mixture within 30 minutes after preparing. If 30 minutes have passed, throw away the mixture.
  • You may take or give this medicine from a cup, oral dosing syringe, or feeding tube.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If it is more than 6 hours until the time you normally take a dose, take it as soon as you remember. If it is less than 6 hours until your regular time, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• If you vomit, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dabrafenib works. Tell your doctor if you are also using clarithromycin, dexamethasone, gemfibrozil, ketoconazole, midazolam, nefazodone, warfarin, or birth control pills.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills. Use an effective form of birth control during treatment with this medicine and for at least 2 weeks after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, diabetes, low blood pressure, or G6PD deficiency. Tell your doctor if you plan to have surgery, including dental surgery.
• This medicine may cause the following problems:
  • Increased risk for other cancers (skin and non-skin cancer)
  • Increased risk of bleeding
  • Heart problems
  • Eye or vision problems
  • Fever (which may be serious)
  • Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS)
  • High blood sugar
  • Hemophagocytic lymphohistiocytosis (HLH), which can be life-threatening
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash, or swollen, painful, or tender lymph glands in neck, armpit, or groin
• Change in how much or how often you urinate
• Cough, chills, fever, especially with stiff muscles, dizziness or lightheadedness
• Eye pain, vision changes, sensitivity to light
• Increased hunger or thirst
• Redness, swelling, peeling, or tenderness of the hands or feet
• Sores or white patches on your lips, mouth, or throat
• Swollen glands
• Trouble breathing, uneven heartbeat, rapid weight gain
• Unusual bleeding, bruising, or weakness
• Warts, skin sores, or reddish bumps that do not heal

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Constipation, diarrhea, nausea, vomiting, stomach pain
• Dry skin, pimples
• Hair loss, redness, soreness, or loosening of the fingernails
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088