Dabrafenib may be used alone or in combination with another medication (trametinib) to treat a type of skin cancer (melanoma) that has spread or cannot be removed by surgery and has a certain type of abnormal "BRAF" gene. Dabrafenib belongs to a class of drugs known as kinase inhibitors. It works by slowing the growth of skin 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. Swallow the capsules whole. Do not open, crush, chew, or break the capsules.
The dosage is based on your medical condition and response to treatment.
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. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Dabrafenib may cause new skin cancers (including cutaneous squamous cell carcinoma) that can spread to other parts of the body. Tell your doctor right away if you have any skin changes, including: new wart, skin sore, change in size/color of a mole, skin bump that bleeds or does not heal.
This medication may rarely make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor right away if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
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 infection (such as fever, chills, persistent sore throat, cough), dizziness/fainting, unusual dry mouth/thirst, signs of kidney problems (such as change in the amount of urine).
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. Therefore, tell your doctor right away if you develop any rash.
Dabrafenib in combination with trametinib may rarely cause other serious side effects. Get medical help right away if you have any very serious side effects, including: signs of bleeding in the brain (such as severe headache, weakness on one side of the body, vision problems, slurred speech, seizures, or confusion), signs of stomach/intestinal bleeding (such as black/bloody stools, vomit that contains blood or looks like coffee grounds, or dizziness), sudden pain/swelling/redness (usually in the leg), chest pain, trouble breathing, new lumps/growth.
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, 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 using 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).
Dabrafenib is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is important that men and women taking this medication use reliable forms of non-hormonal birth control (including condoms and/or diaphragms with spermicide) while taking this medication and for 2 weeks after treatment stops. Men and women taking dabrafenib, in combination with trametinib, should use reliable forms of non-hormonal birth control during treatment and for 4 months after stopping treatment. If you become pregnant, think you may be pregnant, or cause a pregnancy, tell your doctor right away.
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 while using this drug is not recommended. Consult your doctor before breast-feeding.
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 carbamazepine, 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 midazolam, 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as BRAF testing) will be performed before you start treatment and while you are taking this medication to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all appointments as it is important to have regular skin exams while taking dabrafenib and for up to 6 months after stopping it.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. 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.
Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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