Dabrafenib Tablets for Suspension

What is this medication?

DABRAFENIB (da BRAF e nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tafinlar

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Diabetes
• Eye disease
• G6PD deficiency
• Having surgery
• Heart disease
• Kidney disease
• Liver disease
• An unusual or allergic reaction to dabrafenib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Tablets are dissolved in water and taken as a suspension only. Do not swallow whole, chew, or crush the tablets for suspension. Take the dose right away or within 30 minutes of mixing. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is less than 6 hours before the next dose. If it is less than 6 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Lonafarnib
• Mavacamten

This medication may also interact with the following:

• Dexamethasone
• Estrogen and progestin hormones
• Midazolam
• Warfarin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Tell your care team right away if you have any change in your eyesight.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 2 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication and for 2 weeks after the last dose. Your care team can help you find the option that works for you.

Use a condom during sex and for 2 weeks after stopping therapy. Tell your care team right away if you think your partner might be pregnant.

Do not breastfeed while taking this medication and for 2 weeks after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Fever
• Hair loss
• Headache
• Joint pain
• Skin rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.