Uses

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.

How To Use

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. Swallow the capsules whole. Do not open, crush, chew, or break the capsules. If you vomit, do not take another dose to catch up. Take your next dose at the regular time.

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

Side Effects

Hair loss, thickening of the outer layers of the skin, headache, swelling/peeling of feet/hands, and joint/muscle/back pain may occur. 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)
• signs of infection (such as sore throat that doesn't go away, fever, chills, cough)
• 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:

• rash
• swollen lymph nodes
• 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.

Precautions

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. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using dabrafenib. Dabrafenib may harm an unborn baby. Women of childbearing age should ask about reliable forms of non-hormonal birth control (including condoms and/or diaphragms with spermicide) while using this medication and for 2 weeks after the last dose. Men with female partners of childbearing age should use condoms 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, breast-feeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breast-feeding.

Drug Interactions

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 additional reliable 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, midazolam, warfarin, among others.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as BRAF testing) 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.

Missed Dose

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

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original container at room temperature away from light and moisture. Keep the desiccant (drying agent) in the bottle. Do not store in the bathroom. 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.