Description
Dabrafenib is used alone or in combination with trametinib to treat melanoma (skin cancer) that has spread or that cannot be removed by surgery. It is also used together with trametinib to help prevent melanoma from coming back after surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. Dabrafenib is also used together with trametinib to treat non-small cell lung cancer (NSCLC) that has spread and anaplastic thyroid cancer (ATC) that has spread and has no satisfactory treatment options. It is only used if the NSCLC cells and ATC cells have the BRAF V600E mutation. Dabrafenib is also used in combination with trametinib to treat solid tumors that have spread, that cannot be removed by surgery, or that have gotten worse (progressed) and has no satisfactory treatment options. It is only used if the solid tumors have the BRAF V600E mutations. Dabrafenib is also used in combination with trametinib to treat low-grade glioma (LGG) in patients who require other treatments. It is only used if the brain tumor has the BRAF V600E mutations. Your doctor will use a special test to look for these mutations. Dabrafenib belongs to the group of medicines, called antineoplastics (cancer medicines).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dabrafenib to treat melanoma, non-small cell lung cancer, and anaplastic thyroid cancer in children, to treat solid tumors in children younger than 6 years of age, and to treat glioma in children younger than 1 year of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dabrafenib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Mavacamten
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Posaconazole
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abemaciclib
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atorvastatin
- Atrasentan
- Avacopan
- Avanafil
- Avapritinib
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Boceprevir
- Bosutinib
- Budesonide
- Buprenorphine
- Bupropion
- Buserelin
- Buspirone
- Cabozantinib
- Capivasertib
- Carbamazepine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Dehydration or
- Hypotension (low blood pressure) or
- Kidney failure—Use with caution. May cause side effects to become worse.
- Diabetes or
- Eye problem (eg, iritis, iridocyclitis, uveitis) or
- Heart disease or
- Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—May cause hemolytic anemia (blood disorder) in patients with this condition.
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine usually comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use the capsule:
- Take this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal). Allow about 12 hours between each dose.
- Swallow the capsule whole. Do not open, crush, or break it.
To use the tablet for suspension:
- The tablet should be taken as an oral liquid only. Do not swallow whole, chew, or crush the tablet.
- Add 5 mL of water for 1 to 4 tablets and 10 mL of water for 5 to 15 tablets in a cup.
- Gently stir the mixture with the handle of a teaspoon until the tablets break apart.
- Wait for 3 minutes or more until the tablets has broken up. The liquid should be cloudy white but may contain small pieces.
- Swallow the mixture within 30 minutes after preparing. If 30 minutes have passed, throw away the mixture.
- You may take or give this medicine from a cup, oral dosing syringe, or feeding tube.
- Take or give this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal). You may breastfeed or give baby formula to your child if needed.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For melanoma, non-small cell lung cancer, anaplastic thyroid cancer, solid tumors, and glioma:
- For oral dosage form (capsules):
- Adults—150 milligrams (mg) 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 51 kilograms (kg) or more—150 milligrams (mg) 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 38 to 50 kg—100 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 26 to 37 kg—75 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing less than 26 kg—Use of tablet for suspension is recommended.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets for suspension):
- Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 51 kilograms (kg) or more—150 milligrams (mg) 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 46 to 50 kg—130 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 42 to 45 kg—110 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 38 to 41 kg—100 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 34 to 37 kg—90 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 30 to 33 kg—80 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 26 to 29 kg—70 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 22 to 25 kg—60 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 18 to 21 kg—50 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 14 to 17 kg—40 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 10 to 13 kg—30 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Weighing 8 to 9 kg—20 mg 2 times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor.
- For oral dosage form (capsules):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 6 hours until your next regular dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and it is more than 6 hours until your next dose, take it as soon as possible and go back to your regular dosing schedule.
If you vomit, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, diaphragms, contraceptive foams or jellies) along with your pills. Use an effective form of birth control during treatment with this medicine and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Some men and women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.
This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.
This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding.
Dabrafenib may cause heart problems. Check with your doctor right away if you have chest discomfort or pain, dizziness or faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble with breathing, or unusual tiredness or weakness.
Check with your doctor right away if eye pain or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may cause fever, including severe fever that sometimes happens with low blood pressure, chills, dehydration, or kidney problems. Check with your doctor right away if you have a fever while using this medicine.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, sore throat, trouble breathing or swallowing, swelling of your hands, face, mouth, or throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine.
This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.
This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis (HLH), which is caused by an overactive immune system. Check with your doctor right away if you have a bruising, fever, skin rash, or swollen glands.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding gums
- bloody, black, or tarry stools
- bloody or cloudy urine
- blurred vision
- coughing up blood
- difficulty in breathing or swallowing
- dizziness
- dry mouth
- fever
- flushed, dry skin
- fruit-like breath odor
- greatly decreased frequency of urination or amount of urine
- headache
- heartburn
- increased hunger
- increased thirst
- increased urination
- indigestion
- lump or growth on the skin
- nausea
- nosebleed
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- skin blisters
- skin rash
- stomach pain or cramps
- sweating
- swelling of the feet or lower legs
- tingling of the hands and feet
- ulceration of the skin
- unable to move
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
- vomiting of material that looks like coffee grounds, severe and continuing
Less common
- Blurred vision or other change in vision
- change in color vision
- difficulty seeing at night
- eye pain
- increased sensitivity of the eyes to sunlight
- redness of the eye
- tearing
Incidence not known
- Blistering, peeling, loosening of the skin
- chills
- cough
- diarrhea
- itching
- joint or muscle pain
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on lips
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acne, pimples
- back pain
- bloating
- difficulty having a bowel movement
- fast heartbeat
- hair loss or thinning of the hair
- loosening of the fingernails
- loss of appetite
- muscle ache or stiffness
- pains in the stomach, side, or abdomen, possibly radiating to the back
- redness or soreness around the fingernails
- stuffy or runny nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20061178
