Tafinlar Capsules

Tafinlar Capsules is a brand of medicine containing the active ingredient dabrafenib.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

TAFINLAR®

dabrafenib (as mesilate) 50 and 75 mg capsules


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start using TAFINLAR.

This leaflet answers some common questions about TAFINLAR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking TAFINLAR against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

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What TAFINLAR is used for

TAFINLAR is a medicine used to treat people with melanoma (a form of skin cancer) that has spread to other parts of the body or cannot be removed by surgery.

The active substance in TAFINLAR is dabrafenib, TAFINLAR can be used by itself or in combination with trametinib (MEKINIST). If you are taking these two medicines together, read the trametinib leaflet as well as this leaflet.

TAFINLAR can only be used to treat melanomas with a change (mutation) in the BRAF gene, so your doctor must take tumour tissue samples first, to test whether TAFINLAR is suitable for you.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

TAFINLAR is not recommended for use in children and adolescents. The effects of TAFINLAR in people younger than 18 years old are not known.

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Before you take TAFINLAR

Your doctor may decide to treat your melanoma with a combination of TAFINLAR and trametinib. If you are taking these two medicines together, read the trametinib leaflet as well as this leaflet carefully.

When you must not take it

Do not take TAFINLAR if you have an allergy to:

  • dabrafenib mesilate (active ingredient), or
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor or nurse if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or nurse if you have or have had any of the following medical conditions:

  • if you have any liver problems. Your doctor may take blood samples to monitor your liver function while you are taking TAFINLAR.
  • if you have or have ever had any kidney problems.
  • if you have diabetes or high levels of sugar in your blood.

If you are taking the combination of TAFINLAR and trametinib your doctor also needs to know:

  • if you have heart problems such as heart failure or problems with the way your heart beats.
  • if you have eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid blockage (chorioretinopathy).
  • if you have any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue.
  • if you have any skin problems including rash or acne-like rash.

Check with your doctor if you think any of these may apply to you.

Tell your doctor or nurse if you are pregnant or plan to become pregnant. Your doctor can discuss with you the risks and benefits involved.

TAFINLAR alone and in combination with trametinib are not recommended during pregnancy. TAFINLAR can harm an unborn baby.

If you are a woman who could become pregnant you must use reliable birth control while you are taking TAFINLAR and for 28 days after you stop taking it, and for at least 4 months following the last dose of trametinib when taken in combination with TAFINLAR.

Birth control using hormones (such as pills, injections or patches) may not work as well while you are taking TAFINLAR. You need to use another reliable method of birth control, such as condoms so you don't become pregnant while you are taking TAFINLAR. Ask your doctor or nurse for advice.

Tell your doctor or nurse if you are breast feeding. It is not known whether the ingredients of TAFINLAR can pass into breast milk.

TAFINLAR is not recommended while breast feeding. You and your doctor will decide if you will take TAFINLAR or breast feed.

If you are a man taking TAFINLAR, you may have reduced sperm count while you are taking it. Your sperm count may not return to normal levels after you stop taking TAFINLAR.

If you have any further questions on the effect of this medicine on sperm count, ask your doctor.

If you have not told your doctor about any of the above, tell him/her before you start taking TAFINLAR.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect how TAFINLAR works, or make it more likely that you will have side effects. TAFINLAR can also affect how some other medicines work. These include:

  • birth control using hormones such as pills, injections, or patches
  • warfarin, to thin blood
  • medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, posaconazole
  • some antibiotic medicines, such as clarithromycin, telithromycin or rifampicin
  • some immunosuppressants
  • medicines that reduce stomach acid such as omeprazole
  • some anti-inflammatory medicines such as dexamethasone
  • some medicines to treat HIV, such as ritonavir, saquinavir and atazanavir
  • medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, or carbamazepine
  • anti-depressant medicines such as nefazodone and the herbal medicine St John's wort (Hypericum perforatum)

Tell your doctor or nurse if you are taking any of these (or if you are not sure). Your doctor may decide to adjust your dose.

Keep a list of medicines you take, so you can show it to your doctor or nurse when you get a new medicine.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

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How to take TAFINLAR

Follow all directions given to you by your doctor, pharmacist or nurse carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box or bottle, ask your doctor or nurse for help.

How much to take

The usual dose of TAFINLAR is 150 mg (two 75 mg capsules), taken twice a day (total 300 mg daily).

Your doctor may decide that you should take a lower dose if you get side effects.

Do not take any more TAFINLAR than your doctor has recommended.

How to take it

Swallow the capsules whole with a full glass of water one after the other.

Take TAFINLAR twice a day on an empty stomach, so:

  • after taking TAFINLAR, wait at least 1 hour before eating
    or
  • after eating wait at least 2 hours before taking TAFINLAR

When to take it

Take your medicine at about the same two times each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Taking TAFINLAR in combination with trametinib

Swallow the TAFINLAR capsules and the trametinib tablets, with a full glass of water.

Take TAFINLAR in combination with trametinib exactly as your healthcare provider tells you. Do not change your dose or stop TAFINLAR in combination with trametinib unless your healthcare provider tells you.

Take the first dose of TAFINLAR in the morning and take the second dose of TAFINLAR separately in the evening approximately 12 hours later.

When TAFINLAR and trametinib are taken in combination take trametinib at the same time each day with either the morning or the evening dose of TAFINLAR.

Do not take the morning and evening doses of TAFINLAR at the same time, and do not take more than one dose of trametinib a day.

If you take too much TAFINLAR or trametinib, call your doctor or poison control or go to the nearest hospital right away. Take TAFINLAR capsules and trametinib tablets with you when possible.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Do not stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

If you forget to take it

If the missed dose is less than 6 hours late, take it as soon as you remember.

If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time. Then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your doctor, nurse or pharmacist for some hints.

If you take too much (overdose)

In Australia, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, if you think that you or anyone else may have taken too much TAFINLAR.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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While you are using TAFINLAR

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking TAFINLAR.

Tell any other doctors, dentists, nurses and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests (from time to time to make sure the medicine is working and to prevent unwanted side effects.

Conditions you may need to look out for

Some people taking TAFINLAR develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking TAFINLAR

Fever: Taking TAFINLAR may cause fever.

Tell your doctor or nurse immediately if you get a fever while you are taking TAFINLAR.

Changes to your skin before, during and after treatment. Tell your doctor immediately if you notice any changes to your skin while taking this medicines.

Your doctor will check your skin before you start taking TAFINLAR and regularly while you are taking this medicine.

Eye Problems: You should have your eyes examined by your doctor while you are taking TAFINLAR. Tell your doctor immediately if you get eye redness and irritation, blurred vision, eye pain or other vision changes during your treatment.

Strong abdominal pain: Taking TAFINLAR may cause inflammation of the pancreas. Tell your doctor immediately if you notice strong abdominal pain.

High sugar levels in the blood: Patients with a history of diabetes required more intensive therapy to reduce their blood sugar while taking TAFINLAR. Tell your doctor if you notice symptoms of excessive thirst or increase in the volume or frequency of urination.

If you are elderly, you may experience more severe side effects.

In clinical trials patients older than 65 years had more side effects that resulted in amendments to their dose and had higher numbers of severe side effects. Your doctor is aware of this.

Things you must not do

Do not take TAFINLAR to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how TAFINLAR affects you.

Be careful when drinking alcohol while you are taking this medicine.

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Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TAFINLAR. Like all medicines, TAFINLAR can cause side effects but not everybody gets them. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Signs you need to look out for

Tell your doctor or pharmacist if you notice any of the following signs:

  • Fever (high temperature)
    Taking TAFINLAR may cause fever. Tell your doctor or nurse immediately if you get a persistent high temperature while you are taking TAFINLAR. They will carry out tests to find out if there are other causes for the fever and treat the problem.
    In some cases, people with fever may develop low blood pressure and dizziness. If the fever is severe, your doctor may recommend that you stop talking TAFINLAR while they treat the fever with other medicines. Once the fever is controlled, your doctor may recommend that you start taking TAFINLAR again.
  • Changes in your skin
    If you notice any changes in your skin while taking this medicine, please talk to your doctor or nurse as soon as possible.
    Up to 1 in 10 people taking TAFINLAR may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). Usually, these lesions remain local and can be removed with surgery and people can continue treatment.
    Some people taking TAFINLAR also may notice that new melanomas have appeared. These lesions are usually removed by surgery and people can continue treatment.
    Your doctor will check your skin before you start taking TAFINLAR, then check it again every month while you are taking TAFINLAR and for 6 months after you stop taking TAFINLAR, to look for any new skin cancers.
    Check your skin regularly whilst taking TAFINLAR and if you notice any of the following:
    - new wart
    - skin sore or reddish bump that bleeds or does not heal
    - change in size or colour of a mole
    Tell your doctor or nurse as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
  • Eye problems
    TAFINLAR can cause an eye problem called uveitis which could damage your vision if it is not treated. Uveitis may develop rapidly; symptoms include:
    - eye redness and irritation
    - blurred vision
    - eye pain
    - increased sensitivity to light
    - floating spots before the eyes
    Contact your doctor or nurse immediately if you get these symptoms.
    It is very important to tell your doctor or nurse immediately if you develop these symptoms,
    especially if you have a painful, red eye that does not clear up quickly. They may arrange for you to see a specialist eye doctor for a complete eye examination.
  • High sugar levels in the blood
    Patients taking TAFINLAR can develop high blood sugar levels. In some patients with a history of diabetes, an increase in the dose or initiation of therapy to treat high blood sugar was required. Tell your doctor if you notice symptoms of excessive thirst or increase in the volume or frequency of urination.

Possible side effects when taking TAFINLAR alone

Very common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect more than 1 in 10 people.

  • Thickening of the outer layers of the skin
  • Skin effects such as rash, wart-like growths, or redness and swelling of the palms, fingers and soles of the feet
  • Headache
  • Nausea, Vomiting, or Diarrhoea
  • Decreased appetite
  • Chills
  • Feeling weak
  • Lack of energy
  • Fever
  • Joint pain, muscle pain, or pain in the hands or feet
  • Cough
  • Unusual hair loss or thinning

Common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 10 people.

  • Constipation
  • Flu-like illness
  • Nasal inflammation
  • Low phosphorus in the blood, which shows up in blood tests
  • An increase in blood sugar which can be detected in blood tests
  • Changes in how the heart pumps blood
  • Skin effects including rough scaly patches of skin, brown or yellowish thickening of the skin, skin tags, dry skin or redness of the skin

Uncommon side effects

Tell your doctor or pharmacist if you notice any of the following that may affect less than 1 in 100 people.

  • Inflammation of the eye (Uveitis, see eye problems)
  • Inflammation of the pancreas. Your doctor will monitor you closely if you suffer from pancreatitis and then start taking TAFINLAR again.
  • Allergic reaction
  • New melanoma
  • Kidney problems
  • Inflammation of the fatty layer under the skin, symptoms include tender skin nodules
  • Disturbance in heart rhythm

Possible side effects when taking TAFINLAR together with trametinib

Refer to the Patient Information leaflet for trametinib for possible side effects and important signs and symptoms to look out for.

When you take Tafinlar and trametinib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).

Very common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect more than 1 in 10 people.

  • Fever
  • Urinary tract infection
  • Headache
  • Decreased appetite
  • Chills
  • Dizziness
  • Night sweats
  • Joint pain, muscle pain, or pain in the hands or feet
  • Muscle spasms
  • Skin problems
  • Bleeding, at various sites in the body, which may be mild or serious
  • Flu-like illness
  • Skin effects including rough scaly patches of skin, brown or yellowish thickening of the skin, skin tags
  • Skin effects such as rash, wart-like growths
  • Swelling of the feet

Very common side effects that may show up in your blood tests

  • Low levels of white blood cells
  • Low levels of haemoglobin (oxygen-carrying pigment)

Common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 10 people.

  • Eye problems (including inflammation of the eye)
  • Low blood pressure
  • Excessive sweating
  • Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)

Common side effects that may show up in your blood tests

  • Decrease in number of blood platelets (cells that help blood to clot)
  • Low levels of sodium in the blood
  • Increase in some substances (enzymes) produced by the liver

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

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After using TAFINLAR

Storage

Keep your capsules in the pack/bottle until it is time to take them. If you take the capsules out of the pack/bottle they may not keep well.

Keep your capsules in a cool dry place where the temperature stays below 30°C.

Do not store TAFINLAR or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

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Product description

What it looks like

  • The TAFINLAR 50 mg capsules are opaque, hard capsules composed of a dark red body and dark red cap containing a white to slightly coloured solid. The capsule shells are imprinted with GS TEW and 50 mg.
  • The TAFINLAR 75 mg capsules are opaque, hard capsules composed of a dark pink body and dark pink cap containing a white to slightly coloured solid. The capsule shells are imprinted with GS LHF and 75 mg.

Ingredients

Each capsule contains 50 or 75 mg of dabrafenib (as mesilate) as the active ingredient.

Each capsule also contains the following excipients:

  • cellulose - microcrystalline,
  • magnesium stearate,
  • silica - colloidal anhydrous,
  • iron oxide red,
  • titanium dioxide,
  • hypromellose,
  • iron oxide black,
  • shellac,
  • butan-1-ol,
  • isopropyl alcohol,
  • propylene glycol,
  • ammonium hydroxide.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

TAFINLAR is supplied in Australia by:
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from patient information groups and books, for example in public libraries.

This leaflet was prepared on 19 February 2015.

TAFINLAR 50 mg: AUST R 200922
TAFINLAR 75 mg: AUST R 200936

The information provided applies only to: TAFINLAR

TAFINLAR is a registered trade mark of the GSK group of companies.

© 2014 GSK

Version 4.0

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CMI provided by MIMS Australia, January 2017  

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