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Tafinlar

dabrafenib (as mesilate) capsules
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Tafinlar. It does not contain all the information that is known about Tafinlar. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What TAFINLAR is used for

The active substance in TAFINLAR is dabrafenib, which belongs to a group of medicines called selective BRAF-inhibitors. 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.
TAFINLAR can only be used to treat melanomas with a change (mutation) in a gene called "BRAF". This mutation may have caused the cancer to develop. TAFINLAR targets proteins made from this mutated gene and slows down or stops the development of your cancer.
TAFINLAR can be used by itself or in combination with another medicine called MEKINIST (containing trametinib). Your doctor may decide to treat your cancer with TAFINLAR alone or in combination with MEKINIST.
If you are taking these medicines together, please read the MEKINIST Consumer Medicine Information as well as this one carefully.
Ask your doctor or nurse if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
TAFINLAR is not recommended for use in children and adolescents. The effects of TAFINLAR in people younger than 18 years old are not known.
This medicine is available only with a doctor's prescription.
It is not addictive.

Before you take TAFINLAR

Before you take TAFINLAR, your doctor will take skin tumour tissue samples to check whether TAFINLAR is suitable for you.

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.

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:
Liver problems - your doctor may take blood samples to monitor your liver function while you are taking TAFINLAR.
Kidney problems.
Diabetes or high levels of sugar in your blood
If you are taking the combination of TAFINLAR and MEKINIST, your doctor also needs to know if you have:
Heart problems, such as heart failure or problems with the way your heart beats
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)
Any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue
Any skin problems including rash or acne-like rash.
Check with your doctor if you think any of these may apply to you.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Pregnancy

TAFINLAR alone or in combination with MEKINIST are not recommended during pregnancy, as the active ingredient(s) can harm an unborn baby.
Tell your doctor or nurse if you are pregnant or plan to become pregnant.
Your doctor can discuss the risks and benefits involved with you.
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
OR
at least 4 months following the last dose of MEKINIST (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.
If you do become pregnant while you are taking TAFINLAR, tell your doctor immediately.

If you are a man taking this medicine

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.

Breast-feeding

Tell your doctor or nurse if you are breast feeding or planning to breast feed.
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 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, a medicine used to thin blood and prevent clots;
Some medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, posaconazole;
Some antibiotic medicines, such as clarithromycin, telithromycin or rifampicin;
Some medicines that suppress the immune system;
Some medicines that reduce stomach acid (such as omeprazole) or antacids;
Some medicines to lower fats (lipids) in the blood stream, such as gemfibrozil;
Some anti-inflammatory medicines such as dexamethasone;
Some medicines to treat HIV, such as ritonavir, saquinavir and atazanavir;
Some medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, or carbamazepine;
Some 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 that 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.

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 bottle, ask your doctor or nurse for help.

When to take it

Take TAFINLAR:
Twice a day, about 12 hours apart from the previous dose
At about the same time each day.
If taking TAFINLAR BEFORE something to eat or drink, take it and then wait at least 1(one) hour before having food or drink.
If taking TAFINLAR AFTER eating a meal or snack, wait at least 2 hours before taking it.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.

How much to take

The usual dose of TAFINLAR is
150 mg taken on an empty stomach as:
Two 75 mg capsules
or
Three 50 mg capsules
You must take 2 TAFINLAR doses each day.
Take the first dose of TAFINLAR in the morning and take the second dose separately in the evening, approximately 12 hours later.
The usual total daily dose is 300 mg. Depending on how you respond to TAFINLAR, your doctor may prescribe you a lower dose or interrupt temporarily the treatment.
Do not take more TAFINLAR than your doctor has recommended.
If you are aged 65 years or more, you can use TAFINLAR at the same dose as for younger adults.

How to take it

Take TAFINLAR on an empty stomach.
Swallow each capsule whole, with a full glass of water. Take the capsules, one after the other, unless your doctor has advised a lower dose.
If you get side effects, your doctor may decide that you should take a lesser dose.
After taking TAFINLAR, wait at least 1 hour before eating.

When taking TAFINLAR in combination with MEKINIST

Take TAFINLAR in combination with MEKINIST exactly as your healthcare provider tells you.
Take the MEKINIST tablet at the same time each day, with EITHER the morning or the evening dose of TAFINLAR capsules.
Swallow the TAFINLAR capsules and the MEKINIST tablet, with a full glass of water.
DO NOT TAKE MORE THAN ONE DOSE OF MEKINIST PER DAY.
Do not change your dose or stop TAFINLAR in combination with MEKINIST unless your healthcare provider tells you.

How long to take it

This is a long term treatment, possibly lasting for months to years.
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 about how long to take TAFINLAR, 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.
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)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice,or go to the nearest hospital if you think that:
You may have taken too many capsules of TAFINLAR, or MEKINIST tablet (if taking the combination), or if
Somebody else may have accidentally taken your medicine(s).
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Take your medications with you.

While you are taking 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.

Monitoring during your treatment

Your doctor may do some tests (from time to time) to make sure the medicine is working and to prevent unwanted side effects.
Your doctor might perform medical examinations during treatment and after stopping treatment with TAFINLAR to look for possible malignancies that could have developed during treatment.
During and after severe high fever events some substances (enzymes) might be abnormally increased and your doctor might measure those and check that your kidneys are working properly.
In case you notice unexplained severe upper stomach pain you might be examined to find out whether you have an inflamed pancreas (pancreatitis). If an inflamed pancreas is confirmed you will have regular blood checks while taking TAFINLAR.
Your eye sight should be examined during therapy with TAFINLAR by a specialist eye doctor.

Signs you may need to look out for

Some people taking TAFINLAR develop other conditions, which can be serious.
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 frequency of severe side effects. Your doctor is aware of this.
While you are taking TAFINLAR, you need to know about the following important signs and symptoms to look out for.
BLEEDING PROBLEMS
Taking TAFINLAR alone (or in combination with MEKINIST) can cause serious bleeding problems, especially in the brain or stomach, that may lead to death.
Tell your doctor or nurse and get medical help immediately if you have any unusual signs of bleeding while you are taking this medicine.
FEVER
Taking TAFINLAR may cause high fever. High fever can also occur more often when you take TAFINLAR capsules together with MEKINIST tablet.
Tell your doctor or nurse immediately if you get a fever 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 taking 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 TO YOUR SKIN BEFORE, DURING AND AFTER TREATMENT
Check your skin regularly whilst taking TAFINLAR and tell your doctor immediately if you notice any changes to your skin while taking this medicine.
Some patients taking TAFINLAR may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). Usually, this lesion remains local and can be removed with surgery and people can continue TAFINLAR treatment.
Tell your doctor immediately if you notice any changes to your skin while taking this medicine
Your doctor will check your skin before you start taking TAFINLAR, regularly while you are taking this medicine, and for some months after you stop taking it.
EYE PROBLEMS
TAFINLAR can cause an eye problem called uveitis which could damage your vision if it is not treated. Uveitis may develop rapidly.
Tell your doctor immediately if you get any vision changes during your treatment.
If symptoms develop, your doctor may arrange for you to see an eye specialist for a complete eye examination.
STRONG ABDOMINAL PAIN
Taking TAFINLAR may cause inflammation of the pancreas.
Tell your doctor immediately if you notice strong abdominal pain.
HIGH BLOOD SUGAR LEVELS 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.

Things you must not do

Do NOT take TAFINLAR with food.
You must take it on an empty stomach.
Do NOT take the morning and evening doses of TAFINLAR at the same time.
TAFINLAR is dosed about every twelve (12) hours.
Do NOT take TAFINLAR to treat any other conditions unless your doctor tells you to.
Do NOT give your medicine to anyone else, even if they have the same condition as you.
It may harm them, even if the signs of illness are the same as yours. This medicine has been prescribed for only you.
Do NOT stop taking your medicine, or lower the dosage, without first checking with your doctor.
This may cause your condition to become worse.

Things to be careful of

Be careful when:
Driving or operating machinery until you know how TAFINLAR affects you.
Drinking alcohol while you are taking this medicine.

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.

Possible side effects when taking TAFINLAR alone

Stop taking this medicine and tell your doctor, nurse, or pharmacist or get medical help immediately if you experience any of the following serious side effects:
New wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole
Severe upper stomach pain
Painful red eye
Eye redness and irritation
Blurred vision
Eye pain
Increased sensitivity to light
Floating spots before the eyes.
Difficulty in breathing or swallowing, dizziness, swelling of the face, lips, tongue or throat, severe itching of the skin, with a red rash or raised bumps
Severely decreased urine output.
Headaches, dizziness, or weakness;
Coughing up blood or blood clots;
Vomit containing blood or that looks like coffee grinds;
Bleeding from the nose;
Red or black stools that look like tar.
Tell your doctor or pharmacist if you notice any of the following:
High fever
Headaches, dizziness, or weakness, coughing up blood or blood clots, vomit that contains blood or that looks like "coffee grounds", bleeding from the nose, or red or black stools
Any changes in your skin, such as a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole
A new melanoma has appeared
Severe upper stomach or strong abdominal pain.
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
Skin effects including:
Rough scaly patches of skin
Brown or yellowish thickening of the skin
Skin tags
Dry skin or
Redness of the skin
Itching.
Common side effects that can show up in blood tests
Some side effects may not give you any symptoms and can only be found when blood tests are done. These side effects are common:
Low phosphorus in the blood, which shows up in blood tests
High blood sugar (glucose).
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
Pain in your left side extending around your back, bloating and hiccups which may indicate inflammation of the pancreas
Allergic reaction (hypersensitivity)
New melanoma
Kidney failure.
RARE SIDE EFFECTS
Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 1000 people.
Changes in the amount or number of times you pass urine which may indicate kidney problems.
Inflammation of the fatty layer under the skin, which can cause red, painful lumps or tender skin nodules.

Possible side effects when taking TAFINLAR together with MEKINIST

Refer to the MEKINIST Consumer Medicine Information for possible side effects and important signs and symptoms to look out for, such as heart problems, eye problems, and rash.
When you take TAFINLAR and MEKINIST together you may get:
Any of the side effects given in the lists above, although the frequency may change (increase or decrease);
A persistent high temperature (fever); in some cases, low blood pressure and dizziness may occur with the fever.
Tell your doctor as soon as possible if you get a fever while taking TAFINLAR in combination with MEKINIST.
It may be necessary to interrupt your treatment to treat the fever.
Stop taking the combination of medicines and tell your doctor immediately if you experience any of the following serious side effects:
Fever, sore throat or mouth ulcers due to infections
Chest pain, trouble breathing, fainting, rapid heart rate, bluish skin discoloration
Headaches, dizziness, or weakness, coughing up blood or blood clots, vomit that contains blood or that looks like "coffee grounds", bleeding from the nose, or red or black stools
Spontaneous bleeding or bruising
Thirst, low urine output, weight loss, dry flushed skin, irritability
Loss of vision
Blurred vision
Sensation of flashing light
Fatigue, feeling full or bloated, heart palpitations, loss of appetite, nausea, reduced ability to exercise, shortness of breath, swelling
Breathlessness, difficulty breathing when lying down, swelling of the feet or legs
Slow heart-beat
Cough, difficult or painful breathing, wheezing, pain in chest when breathing, fever
Nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching
Muscle pain, fever, and red-brown urine.
VERY COMMON SIDE EFFECTS (IN COMBINATION WITH MEKINIST)
Tell your doctor or pharmacist if you notice any of the following (that may affect more than 1 in 10 people):
Urinary tract infection
Dizziness
Chills
High temperature (fever)
Rash, dry skin, itching, acne-like problems
Decreased appetite
Headache
High blood pressure
Cough
Stomach ache
Feeling sick (nausea), or being sick (vomiting)
Diarrhoea
Constipation
Joint pain, muscle pain, or pain in the hands or feet
Swelling of the hands or feet
Lack of energy, feeling weak
Nasal inflammation
Bleeding (haemorrhage)
Decreased weight.
Very common side effects that may show up in your blood tests
Low levels of white blood cells
Abnormal blood test results related to the liver
COMMON SIDE EFFECTS (IN COMBINATION WITH MEKINIST)
Tell your doctor or pharmacist if you notice any of the following (that may affect up to 1 in 10 people):
Low blood pressure
Excessive sweating
Skin effects including:
Rough scaly patches of skin
Skin rash with pus-filled blisters
Brown or yellowish thickening of the skin
Skin tags
Skin cracking
Wart-like growths or redness and swelling of the palms, fingers and soles of the feet
Cutaneous squamous cell carcinoma (a type of skin cancer)
Inflammation of the fatty layer underneath the skin
Papilloma ( a type of skin tumor which is usually not harmful)
Infection of the skin (cellulitis)
Inflammation of hair follicles in the skin
Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
Unusual hair loss or thinning
Dehydration (low levels of water or fluid)
Blurred vision, eyesight problems
Shortness of breath
Sore mouth or mouth ulcers, inflammation of mucous membranes
Dry mouth
Flu-like illness
Muscle spasms
Swelling of face
Night Sweats
Heart pumping less efficiently
Localised tissue swelling
Kidney disorder that may result in decreased urine output.
Common side effects that may show up in tests:
Decrease in the number of:
Platelets (cells that help the blood to clot)
Red blood cells (anaemia). If you have this condition you may experience some of the following symptoms:
Tiredness
Headaches
Shortness of breath when exercising
Dizziness
Looking pale
A type of white blood cells (leukopenia). If you have this condition, you may experience some of the following symptoms:
Frequent infections
Fever
Severe chills
Sore throat or
Mouth ulcers.
Low levels of:
Sodium in the blood
Phosphate in the blood.
Increase in:
Some substances (enzymes) produced by the liver
Creatine phosphokinase, an enzyme found mainly in heart, brain and skeletal muscle
Blood sugar.
UNCOMMON SIDE EFFECTS (IN COMBINATION WITH MEKINIST)
Tell your doctor or pharmacist if you notice any of the following (that may affect less than 1 in 100 people):
Allergic reactions
Eye changes including:
swelling in the eye caused by fluid leakage (chorioretinopathy)
inflammation of the eye (uveitis)
separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment)
swelling around the eyes
Inflammation of pancreas
Acute kidney failure Inflammation of kidneys
Inflammation of the lung (pneumonitis or interstitial lung disease)
New primary melanoma
Changes in how the heart pumps blood (left ventricular dysfunction)
Decreased heart function that may result in symptoms such as:
Difficulty breathing especially when lying down
Fatigue
Swelling of the legs
Muscle disorder with abnormal breakdown of muscle tissue, causing pain, fever and red-brown urine.
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.

After using TAFINLAR

Storage

Keep TAFINLAR capsules in the 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.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If the packaging is torn or shows signs of tampering when you receive it, return it to the pharmacist.
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.
Do not throw TAFINLAR in the general household rubbish or flush it down the toilet.
It may end up in landfill or enter waterways affecting the environment or marine life.
Do not keep old medicines because you think you may need them in the future.
Keeping any unwanted or expired medications runs the risk of unintentional poisonings.

Product description

What TAFINLAR looks like

TAFINLAR capsules are available in plastic bottles containing 120 capsules. The bottle has a child resistant closure.
50 mg capsules
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 printed with GS TEW and 50 mg.
75 mg capsules
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 printed with GS LHF and 75 mg.

Ingredients

Each capsule contains dabrafenib (as mesilate) as the active ingredient. Each capsule also contains the following excipients
Cellulose - microcrystalline (E460)
Magnesium stearate (E572)
Silica - colloidal anhydrous
Iron oxide red (E172)
Titanium dioxide (E171)
Hypromellose (E464)
Iron oxide black (E172)
Shellac
Butan-1-ol
Isopropyl alcohol
Propylene glycol (E1520)
Ammonium hydroxide (E527)
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

TAFINLAR is supplied by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road, Macquarie Park NSW 2113 Australia
Telephone 1 800 671 203
www.novartis.com.au
® Registered Trademark
Australian Registration Numbers:
TAFINLAR 50 mg capsules: AUST R 200922
TAFINLAR 75 mg capsules: AUST R 200936
This leaflet was prepared in January 2017.
Internal document code
(taf060117c based on PI taf060117i)