dabrafenib 75 mg capsule

Generic name:
Dabrafenib - oral

Pronunciation
(da-BRAF-e-nib)

Brand name(s)
Tafinlar

Dabrafenib is used to treat various cancers (such as skin, thyroid, lung, solid tumors, brain). It belongs to a class of drugs known as kinase inhibitors. Dabrafenib works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start taking dabrafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily (about 12 hours apart). Take this medication on an empty stomach, at least 1 hour before or 2 hours after meals. If you vomit, do not take another dose to catch up. Take your next dose at the regular time.

If you are using the capsules, swallow the capsules whole. Do not open, crush, chew, or break the capsules.

If you are using the tablet form of this medication, read the Instructions for Use before you start taking dabrafenib and each time you get a refill. Do not swallow whole, chew or crush the tablets. The tablet(s) must be mixed in water before taking. Ask your doctor or pharmacist how much water you should use to mix the tablet(s). Add water and the prescribed number of tablet(s) to the dosing cup provided. Gently stir with the handle of a teaspoon for at least 3 minutes until the tablet(s) break apart. The mixture should be cloudy white and may contain small pieces. Drink all of the mixture right away. To make sure you have taken all of the medication, add more water to the cup, stir with the handle of a teaspoon, and drink it right away. Repeat if any medicine remains in the cup. Take this medication within 30 minutes of mixing.

The mixture may also be given through a tube into the stomach (nasogastric or gastric tube). If you are giving this medication through a nasogastric or gastric tube, ask your health care professional for detailed instructions on how to give it.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Hair loss, thickening of the outer layers of the skin, headache, swelling/peeling of feet/hands, and joint/muscle/back pain may occur. Weight gain may also occur in children. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Although this medication is used to treat certain skin cancers, it may rarely cause new skin cancer or other cancers. Tell your doctor right away if you notice unusual skin changes (such as skin sores/lumps, warts, change in the size/color of a mole, skin bump that bleeds or does not heal). Your doctor should check your skin before starting treatment, every 2 months during treatment, and for up to 6 months after stopping this medication.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• dizziness/fainting
• signs of kidney problems (such as change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• eye pain/swelling/redness
• vision changes (such as blurred vision, sensitivity to light)
• fast/irregular heartbeat
• signs of bleeding in the brain (such as severe headache, weakness on one side of the body, vision problems, trouble speaking, seizures, or confusion)
• signs of stomach/intestinal bleeding (such as black/bloody stools, vomit that contains blood or looks like coffee grounds, or dizziness)

Dabrafenib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking dabrafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain enzyme deficiency (G6PD deficiency)
• liver disease
• diabetes

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dabrafenib. Dabrafenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) during treatment and for 2 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Other medications can affect the removal of dabrafenib from your body, which may affect how dabrafenib works. Examples include azole antifungals (such as itraconazole, ketoconazole), gemfibrozil, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, St. John's wort, drugs used to treat seizures (such as phenobarbital, phenytoin), among others.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples include daridorexant, elacestrant, mavacamten, midazolam, quizartinib, revumenib, warfarin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as weight monitoring in children) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. It is important to have regular skin exams while taking dabrafenib and for up to 6 months after the last dose.

If you miss a dose, take it as soon as you remember. If it is within 6 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.