dabrafenib (Oral route)

da-BRAF-e-nib

Commonly used brand name(s)

In the U.S.

  • Tafinlar

Available Dosage Forms:

  • Capsule

Pharmacologic Class: BRAF Inhibitor

Uses For dabrafenib

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. Your doctor will use a special test to look for this mutation. Dabrafenib belongs to the group of medicines called antineoplastics (cancer medicines).

Slideshow: Flashback: FDA Drug Approvals 2013

dabrafenib is available only with your doctor's prescription.

Before Using dabrafenib

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 dabrafenib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dabrafenib 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 in the pediatric population. 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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.

Interactions with Medicines

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 dabrafenib, 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 dabrafenib 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.

  • Amifampridine
  • Atazanavir
  • Bepridil
  • Boceprevir
  • Cisapride
  • Cobicistat
  • Dronedarone
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mesoridazine
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Sparfloxacin
  • Telaprevir
  • Terfenadine
  • Thioridazine
  • Tipranavir
  • Ziprasidone

Using dabrafenib 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
  • Ado-Trastuzumab Emtansine
  • Alfentanil
  • Alfuzosin
  • Alprazolam
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Anagrelide
  • Apixaban
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atorvastatin
  • Azilsartan
  • Azithromycin
  • Bedaquiline
  • Bosutinib
  • Brentuximab Vedotin
  • Brinzolamide
  • Bromocriptine
  • Budesonide
  • Buprenorphine
  • Bupropion
  • Buspirone
  • Cabazitaxel
  • Cabozantinib
  • Calcium Carbonate
  • Carbamazepine
  • Celecoxib
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Cilostazol
  • Cimetidine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Delamanid
  • Delavirdine
  • Desipramine
  • Desogestrel
  • Dexamethasone
  • Dexlansoprazole
  • Diclofenac
  • Dienogest
  • Dihydroergotamine
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Disopyramide
  • Docetaxel
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Drospirenone
  • Dutasteride
  • Ebastine
  • Eletriptan
  • Elvitegravir
  • Enzalutamide
  • Eplerenone
  • Ergotamine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Esomeprazole
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Everolimus
  • Famotidine
  • Felbamate
  • Felodipine
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Fluticasone
  • Fluvastatin
  • Formoterol
  • Fosamprenavir
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemfibrozil
  • Gemifloxacin
  • Glipizide
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydrocodone
  • Hydroquinidine
  • Ibuprofen
  • Ibutilide
  • Iloperidone
  • Imatinib
  • Imipramine
  • Indinavir
  • Irbesartan
  • Ivabradine
  • Lansoprazole
  • Lapatinib
  • Letrozole
  • Levofloxacin
  • Levomilnacipran
  • Levonorgestrel
  • Lomitapide
  • Losartan
  • Lovastatin
  • Lumefantrine
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Maraviroc
  • Medroxyprogesterone
  • Mefloquine
  • Meloxicam
  • Mestranol
  • Methadone
  • Midazolam
  • Mifepristone
  • Mitotane
  • Mizolastine
  • Moxifloxacin
  • Naproxen
  • Nateglinide
  • Nefazodone
  • Nifedipine
  • Nilotinib
  • Nisoldipine
  • Nizatidine
  • Norelgestromin
  • Norethindrone
  • Norfloxacin
  • Norgestimate
  • Norgestrel
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Omeprazole
  • Ondansetron
  • Ospemifene
  • Oxycodone
  • Paclitaxel
  • Paliperidone
  • Pantoprazole
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perampanel
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Phenobarbital
  • Phenytoin
  • Piroxicam
  • Pomalidomide
  • Ponatinib
  • Prednisolone
  • Prednisone
  • Primidone
  • Probucol
  • Procainamide
  • Progesterone
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Rabeprazole
  • Ranitidine
  • Ranolazine
  • Regorafenib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rilpivirine
  • Riociguat
  • Risperidone
  • Roflumilast
  • Rosiglitazone
  • Salmeterol
  • Saxagliptin
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sildenafil
  • Siltuximab
  • Simeprevir
  • Simvastatin
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sulfamethoxazole
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tamsulosin
  • Telavancin
  • Telithromycin
  • Temsirolimus
  • Tetrabenazine
  • Ticagrelor
  • Tizanidine
  • Tocophersolan
  • Tolbutamide
  • Tolterodine
  • Tolvaptan
  • Topotecan
  • Toremifene
  • Torsemide
  • Trabectedin
  • Tramadol
  • Trazodone
  • Triamcinolone
  • Triazolam
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vilazodone
  • Vincristine
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin
  • Zaleplon
  • Zileuton
  • Zolpidem

Interactions with Food/Tobacco/Alcohol

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 dabrafenib. Make sure you tell your doctor if you have any other medical problems, especially:

  • 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.

Proper Use of dabrafenib

Medicines used to treat cancer are very strong and can have many side effects. Before using dabrafenib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take dabrafenib 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.

dabrafenib usually comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take dabrafenib at least 1 hour before or 2 hours after a meal.

Swallow the capsule whole. Do not open, crush, or break it.

Dosing

The dose of dabrafenib 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 dabrafenib. 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 oral dosage form (capsules):
    • For melanoma (skin cancer):
      • Adults—150 milligrams (mg) two times a day, taken 12 hours apart.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dabrafenib, 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.

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 While Using dabrafenib

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Using dabrafenib while you are pregnant can harm your unborn baby. Use an effective form of birth control during therapy 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.

Birth control pills may not work as well while you are using dabrafenib. To keep from getting pregnant, use another form of birth control together with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

dabrafenib may cause fertility (ability to have children) problems in men. Talk to your doctor before using dabrafenib if you plan to have children.

dabrafenib 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 to be checked for new skin lesions before therapy, during therapy, and for up to 6 months after the last dose.

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 you to have your eyes checked by an ophthalmologist (eye doctor).

dabrafenib 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 taking dabrafenib.

dabrafenib may cause hyperglycemia (high blood sugar). Symptoms include blurred vision, dry mouth, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, nausea, sweating, troubled breathing, unexplained weight loss, or vomiting. If you are a diabetic, check with your doctor if you notice a change in the results of your blood or urine sugar tests.

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 (eg, St John's wort) or vitamin supplements.

dabrafenib 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
  • Abdominal or stomach pain
  • bloody or cloudy urine
  • blurred vision
  • dry mouth
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • greatly decreased frequency of urination or amount of urine
  • increased hunger
  • increased thirst
  • increased urination
  • lump or growth on the skin
  • nausea
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • skin blisters
  • skin rash
  • sweating
  • swelling of the feet or lower legs
  • tingling of the hands and feet
  • troubled breathing
  • ulceration of the skin
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
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

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
  • Back pain
  • constipation
  • cough
  • darkened urine
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fast heartbeat
  • hair loss or thinning of the hair
  • headache
  • indigestion
  • loss of appetite
  • muscle aches
  • muscle pain or stiffness
  • pain in the joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • sore throat
  • stuffy or runny nose
  • yellow eyes or skin

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.

See also: Side effects (in more detail)

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