Dabrafenib

WHY is this medicine prescribed?

Dabrafenib is used to treat certain types of melanoma (a type of skin cancer), lung cancer, thyroid cancer, glioma (a cancerous brain tumor), and certain other solid tumors. Dabrafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dabrafenib comes as a capsule to take by mouth and as a tablet to suspend in water and take by mouth. It is usually taken twice a day on an empty stomach, 1 hour before or 2 hours after a meal. Take dabrafenib about 12 hours apart at around the same times every day.

Take dabrafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking dabrafenib without talking to your doctor.

Swallow the capsules whole; do not open, break, or crush them. Tell your doctor if you cannot swallow the capsules whole.

If you are taking the tablets for oral suspension, you must mix them with water before use. Do not swallow tablets whole; do not chew or crush them. Do not prepare the mixture more than 30 minutes before you plan to use it. Dispose of the mixture if it is not used after 30 minutes.

Mix the tablets for oral suspension in the dosing cup provided by the manufacturer. If you are taking 1 to 4 tablet(s), place 1 teaspoonful (5 mL) of cool drinking water in a dosing cup. If you are taking 5 to 15 tablets, place 2 teaspoons (10 mL) of water in a dosing cup. Place the tablets into the water and stir for 3 minutes or until mixture is completely dissolved; the mixture will be cloudy. Drink the mixture right away or within 30 minutes after mixing it. Add another 1 teaspoonful of water to the cup and stir to rinse out any particles that are still in the cup. Drink all of this mixture to be sure that you receive all of the medication. Repeat this if you are taking 5 to 15 tablets.

If you vomit after you take dabrafenib, do not take another dose. Continue your regular dosing schedule.

Your doctor may adjust your dose or temporarily or permanently stop your treatment depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dabrafenib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking dabrafenib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• you should know that dabrafenib may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking dabrafenib. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

• tell your doctor if you have or have ever had diabetes; glucose-6-phosphate dehydrogenase (G6PD) deficiency (a genetic condition); bleeding problems; eye problems; heart failure or other heart problems; liver or kidney disease; or any other medical condition.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You may need to take a pregnancy test before starting treatment and should not become pregnant while you are taking dabrafenib. Use effective non-hormonal birth control during your treatment and for 2 weeks after your final dose. Talk to your doctor about birth control methods that will work for you. If your partner can become pregnant, use a condom while taking this medication and for 2 weeks after your treatment, even if you have had a vasectomy (surgery to prevent sperm from leaving your body and causing pregnancy). If you or your partner becomes pregnant while taking dabrafenib, call your doctor. Dabrafenib may harm the fetus.

• you should know that this medication may make it harder for men and women to have children. Talk to your doctor about the risks of taking dabrafenib.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking dabrafenib and for 2 weeks after your final dose.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dabrafenib.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Dabrafanib may make your skin sensitive to sunlight.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is less than 6 hours until your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dabrafenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• joint, muscle, or back pain
• nausea
• diarrhea
• constipation
• loss of appetite
• cough, runny nose, or sore throat
• hair loss
• tiredness
• thickening of the skin
• infection of the skin around the fingernails or toenails
• numbness and tingling of the arms, hands, legs, or feet
• dry skin

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• changes in skin (new wart, pimple, skin sore, or red bump that bleeds or does not heal) or change in size or color of a mole
• fever, chills, or shaking
• dizziness, lightheadedness, or weakness; fainting; or decreased urination
• increased thirst or increased or more frequent urination
• eye pain; red or swollen eyelids; sensitivity to light; or blurred vision or vision changes, including seeing halos (blurred outline around objects) or colored dots
• rash; blistering, peeling, or reddened skin; blistering of the lips, eyes, or mouth; flu-like symptoms; and swollen glands, with or without fever
• fever, swollen glands, bruising, and rash
• ongoing pain that begins in the stomach area but may spread to the back
• unusual bleeding or bruising; bloody or black, tarry stools; coughing up or vomiting blood or material that looks like coffee grounds; nosebleed; headaches, dizziness, or feeling weak
• chest pain; fast, irregular, or pounding heartbeat; lightheadedness; swelling of the hands, feet, ankles or lower legs; or shortness of breath
• yellowing of the skin and eyes

Dabrafenib may increase the risk that you will develop new skin cancers or other cancers. Talk to your doctor about the risks of taking this medication.

Dabrafenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with dabrafenib. Your doctor will order certain lab tests before and during your treatment to check your body's response to dabrafenib. Your doctor will check your skin for any changes before, every 2 months during your treatment, and for up to 6 months after treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.