Commonly Used Brand Name(s)Tafinlar
Pharmacologic ClassificationsBRAF Inhibitor
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 only used if the melanoma cells have the BRAF V600E or V600K mutations. It also treats non-small cell lung cancer (NSCLC) that has spread if the NSCLC cells have the BRAF V600E mutation in combination with trametinib. 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.
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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. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Take this medicine at least 1 hour before or 2 hours after a meal.
Swallow the capsule whole. Do not open, crush, or break it.
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.
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.
Use & StorageTOP
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.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of dabrafenib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dabrafenib in the elderly.
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.
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.
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.
- Abiraterone Acetate
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Ethinyl Estradiol
- Inotuzumab Ozogamicin
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 ProblemsTOP
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
- Hyperglycemia (high blood sugar) or
- Iritis (eye problem) or
- Uveitis (eye problem)—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.
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. 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.
This medicine may cause fertility (ability to have children) problems in men and women. 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.
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 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.
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.