Tafinlar

Brand Name

Tafinlar

Common Name

dabrafenib

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

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 alone or with the medication trametinib to treat a specific type of melanoma (skin cancer) that cannot be surgically removed or has metastasized (spread to other parts of the body). It is also used after surgery for melanoma to prevent the melanoma from coming back. Dabrafenib is also used in combination with trametinib to treat a specific type of non-small cell lung cancer (NSCLC) that has metastasized.

Dabrafenib may be used to treat low-grade glioma (LGG) and high-grade glioma (HGG) in children older than 1 year of age. Gliomas are tumours that begin in the brain or spinal column.

Dabrafenib is not appropriate for all types of melanoma or NSCLC. It will only interfere with the growth of skin cancer cells that have a particular genetic mutation in a gene called BRAF V600. 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 to treat melanoma or NSCLC is 150 mg (2x75 mg capsules) taken by mouth 2 times a day for 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 approximately 12 hours between doses. Swallow the capsules whole with a full glass of water.

To treat glioma, the dose of dabrafenib for children 1 year of age and older, who weigh at least 8 kg, is based on body size. Children who weigh 26 kg or more can take capsules. Children who weigh less than 26 kg should be given the tablets for suspension.

The tablets for suspension should be prepared in the dosing cup that is provided with the medication. Put 5 mL to 10 mL of cool drinking water in the dosing cup, then add the prescribed number of tablets to make up the dose. Gently stir the water and tablets with the handle of a spoon until the tablets are completely dissolved. This may take up to 3 minutes. The water should be cloudy white. You may give the medication directly from the medicine cup or an oral syringe. If given by oral syringe, the tip of the syringe should touch the inside of either cheek, and the child should be sitting upright to reduce the risk of choking.

Rinse the medication cup with 5 mL of water and stir with the handle of the spoon again to loosen any medication that is stuck on the side of the cup. Have the child drink the remaining suspension. If the dose is 10 mg to 40 mg (1 to 4 tablets), rinse the cup once. If the dose is larger than 40 mg, rinse the cup and have the child drink the remaining contents twice.

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 vomit after taking a dose, do not take another dose. Continue with your regular schedule.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 6 hours until 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?

Capsule

50 mg
Each opaque, dark red capsule, monogrammed with "GSTEW" and "50 mg" contains 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.

75 mg
Each opaque, dark pink capsule, monogrammed with "GSLHF" and "75 mg" contains 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.

Tablet for Suspension

10 mg
Each white-to-slightly-yellow, round, biconvex, 6 mm tablet, debossed with “D” on one side and “NVR” on the other, contains 10 mg of dabrafenib as dabrafenib mesylate. Nonmedicinal ingredients: acesulfame potassium, artificial berry flavour, colloidal silicon dioxide (silica, colloidal anhydrous), crospovidone, hypromellose (hydroxypropyl methyl cellulose), magnesium stearate, mannitol, and microcrystalline cellulose (cellulose, microcrystalline).

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
• chills
• constipation
• cough
• decreased appetite
• diarrhea
• dizziness
• dry mouth
• dry skin
• hair loss or thinning
• headache
• increased sensitivity of skin to sunlight
• increased sweating
• itching
• lack of energy
• mouth sores or ulcers
• muscle spasms
• nausea
• nail changes
• rash
• skin tags
• stomach pain
• thickened skin
• tingling, burning pain on palms
• vomiting
• weakness
• weight changes

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:

• blood pressure changes (high or low)
• changes to skin colour, thickness, or texture
• chills
• fever
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
• inflammation inside the nose
• joint or muscle pain
• new lesions on skin
• night sweats
• redness and swelling or peeling of fingers, palms, soles of feet
• shortness of breath
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• 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 worse 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 dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• 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, or a rapid, pounding, or irregular heartbeat
• skin infection (e.g., swelling, warmth, redness, pus)
• swelling of the hands, ankles, or feet
• 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)
• symptoms of lung inflammation (e.g., shortness of breath, cough, fatigue, loss of appetite, unintentional weight loss)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• 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 a life-threatening blood disorder (e.g., fever, swollen glands, bruising, rash, enlarged abdomen, or liver, kidney, and heart problems)
• 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)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

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.

Birth control: Anyone whose partners are or may become pregnant, should use condoms during sexual activity while they are taking dabrafenib and for at least 2 weeks after the last dose of dabrafenib. People who may become pregnant should use effective methods of birth control while taking dabrafenib and for at least 2 weeks after the last dose of dabrafenib.

If you are taking trametinib in addition to dabrafenib, birth control must be used for at least 16 weeks following the last dose of trametinib.

Dabrafenib is likely to decrease the effectiveness of hormonal birth control (e.g., pills, patches, injections) so these should not be used as the only form of birth control.

Bleeding: People taking the combination of trametinib and dabrafenib may be more likely to have difficulty stopping 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 a 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. If you have diabetes, you may find it necessary to monitor your 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: People 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, or 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, or 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.

Pancreatitis: Dabrafenib can cause the pancreas to become inflamed. If you have a history of pancreatitis, 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.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

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. People who could become pregnant who are taking dabrafenib should use an effective method of birth control such as condoms during treatment and for 2 weeks after stopping the medication.

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, you should either stop either breast-feeding or not use this medication. 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.

Children: The safety and effectiveness of using this medication to treat melanoma or NSCLC have not been established for children. The safety and effectiveness of using this medication to treat glioma for children at least 1 year of age and weighing 8 kg have been determined. Smaller, younger children should not receive this medication.

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?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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 – 2024. 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