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Medications Lexicon

How does this medication work? What will it do for me?

Dabrafenib belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the family of medications called protein kinase inhibitors. It is used to treat a specific type of melanoma (skin cancer) that cannot be surgically removed or has metastasized (spread to other parts of the body).

Dabrafenib has also been granted a notice of compliance with conditions (NOC/c) by Health Canada, when it is used with trametinib. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

Dabrafenib is not appropriate for all types of melanoma. It will only interfere with the growth of skin cancer cells that have a particular genetic mutation in a gene called BRAF. Your doctor will check for this mutation before dabrafenib is prescribed.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended adult dose of dabrafenib is 150 mg (2x75 mg capsules) taken by mouth two times a day to give a total of 300 mg daily. This medication should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal and with an interval of at least 12 hours between doses. Swallow the capsules whole with a full glass of water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is within 6 hours of your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

50mg
Each opaque, dark red capsule, monogrammed with "GSTEW" and "50 mg"" contain 50 mg of dabrafenib as dabrafenib mesylate. Nonmedicinal ingredients: magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). Monogramming ink contains black iron oxide, shellac, and propylene glycol.

75mg
Each opaque, dark pink capsule, monogrammed with "GSTEW" and "75 mg"" contain 75 mg of dabrafenib as dabrafenib mesylate. Nonmedicinal ingredients: magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). Monogramming ink contains black iron oxide, shellac, and propylene glycol.

Who should NOT take this medication?

Do not take this medication if you are allergic to dabrafenib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne-like skin condition
  • constipation
  • cough
  • decreased appetite
  • diarrhea
  • dry mouth
  • dry skin
  • hair loss or thinning
  • headache
  • increased sweating
  • lack of energy
  • mouth sores or ulcers
  • nausea
  • nail changes
  • rash
  • stomach pain
  • thickened skin
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • changes to skin colour, thickness, or texture
  • chills
  • fever
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • increased blood pressure
  • inflammation inside the nose
  • irregular heart beat
  • joint or muscle pain
  • low blood pressure
  • new lesions on skin
  • redness and swelling of fingers, palms, soles of feet
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood,  bleeding gums, cuts that don’t stop bleeding)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
  • signs and symptoms of changes in heart rhythm including feeling dizzy or faint, seizures, palpitations, feeling a rapid, pounding or irregular heart beat
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of low sodium levels in the blood (e.g., achy, stiff or uncoordinated muscles, confusion, tiredness, weakness)
  • vision changes (e.g., redness, swelling, blurred vision, eye pain, pain or irritation by light)
  • wart-like growths

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • fever with chills, dizziness or dehydration, or low blood pressure
  • signs of bleeding in the stomach (e.g., bloody, black, or  tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: People taking the combination of trametinib and dabrafenib may be more likely to make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood clots: People who take dabrafenib in combination with trametinib may be at increased risk of developing blood clots, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood-clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Diabetes: Dabrafenib may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Eye inflammation: Dabrafenib may cause eye inflammation. If you experience eye pain, changes in your vision or eye pain when you are exposed to light, contact your doctor as soon as possible.

Fertility: Men who take dabrafenib may develop a decreased sperm count that may not return to normal levels after you stop taking dabrafenib. Discuss your concerns with your doctor before starting to take dabrafenib.

Fever: Dabrafenib may cause an increase in body temperature (fever) that is not related to infection. This may be more likely to happen to people who take trametinib along with dabrafenib. If you experience a fever while taking dabrafenib, contact your doctor as soon as possible.

Heart rhythm: Dabrafenib can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., have heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: People taking dabrafenib along with trametinib, may be more likely to experience a reduced number of cells that fight infection in the body (white blood cells), and are more likely to develop severe infections. If possible, avoid contact with people with contagious infections.  Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Dabrafenib may cause kidney failure, as a result of high fever and dehydration. Your doctor will do blood tests to monitor kidney function while you are using this medication. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other cancers: New cancerous lesions on the skin, such as squamous cell cancer or new melanomas can occur while you are taking dabrafenib. It is important to have your skin examined before starting this medication, every 2 months while you are taking this medication and until 6 months after stopping the medication. Signs of squamous cell cancer include sores, warts of bumps that bleed or do not heal. Signs of melanoma include moles with an irregular shape, border, or colour that are changing shape or are growing. If you notice any of these signs, contact your doctor as soon as possible.

It is also possible to develop other cancers while taking dabrafenib. Discuss your concerns with your doctor before starting to take dabrafenib.

Pregnancy: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. Women of childbearing age who are taking dabrafenib should use an effective method of birth control such as condoms during treatment and for 4 weeks after stopping the medication. Dabrafenib is likely to decrease the effectiveness of birth control pills, which should not be used as the only form of birth control.

Breast-feeding: It is not known if dabrafenib passes into breast milk. Because there is a high likelihood of causing harm to a nursing infant if this medication does pass into breast milk, it is advisable that either breast-feeding be stopped or the medication not used. Talk to your doctor about the risks and benefits of breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may be more likely to experience side effects of this medication and may require a lower dose.

What other drugs could interact with this medication?

There may be an interaction between dabrafenib and any of the following:

  • abiraterone
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • amphoteracin B
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide, sodium bicarbonate)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apixaban
  • aprepitant
  • aripiprazole
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., phenobarbital, secobarbital)
  • benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
  • bexarotene
  • bicalutamide
  • birth control pills (estrogen/progestin)
  • bisoprolol
  • boceprevir
  • bosentan
  • buprenorphine
  • bupropion
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cancer medications (e.g., busulfan, cyclophosphamide, tamoxifen, vinblastine)
  • celecoxib
  • chloroquine
  • clopidogrel
  • conivaptan
  • cyclosporine
  • cyproterone
  • daclatasvir
  • dantrolene
  • dapsone
  • darifenacin
  • deferasirox
  • dexamethasone
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • disopyramide
  • dofetilide
  • domperidone
  • dronedarone
  • efavirenz
  • eltrombopag
  • enzalutamide
  • escitalopram
  • estrogens (e.g., estradiol, estropipate)
  • everolimus
  • fentanyl
  • flecainide
  • flutamide
  • fesoterodine
  • gemfibrozil
  • grapefruit juice
  • H2-antagonists (antacids; e.g., famotidine, ranitidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • imipramine
  • irbesartan
  • isosorbide dinitrate/mononitrate
  • lidocaine
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • mestranol
  • methadone
  • metronidazole
  • mifepristone
  • mirtazapine
  • moclobemide
  • modafinil
  • montelukast
  • naloxegol
  • nefazodone
  • oxycodone
  • pentamidine
  • perampanel
  • pimozide
  • praziquantel
  • primaquine
  • progestins (e.g., levonorgestrel, progesterone, mestranol)
  • promethazine
  • propafenone
  • other protein kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole, pantoprazole)
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • rifabutin
  • rifampin
  • rilpivirine
  • riociguat
  • rivaroxaban
  • roflumilast
  • romidepsin
  • St. John's wort
  • selegiline
  • seizure medications (e.g., carbamazepine, clobazam, ethosuximide, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sildenafil
  • simeprevir
  • sirolimus
  • solifenacin
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • tacrolimus
  • telaprevir
  • tetracycline
  • theophylline
  • thiazolidinediones (e.g., pioglitazone, rosiglitazone)
  • ticagrelor
  • ticlopidine
  • tolterodine
  • tolvaptan
  • tramadol
  • trazodone
  • tretinoin
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • trimipramine
  • ulipristal
  • venlafaxine
  • warfarin
  • zafirlukast
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2018. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tafinlar

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