Advertisement
Advertisement

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. 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.
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.
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.

Before you take Tafinlar

TAFINLAR can only be used to treat melanomas with a change (mutation) in the BRAF gene. Before you take Tafinlar, your doctor will take skin tumour tissue samples to check whether Tafinlar is suitable for you. 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 Consumer Medicine Information as well as this one 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.

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 trametinib 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.

Pregnancy

Tafinlar alone or in combination with trametinib 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 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.
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.

Breast-feeding

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 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.
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 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.

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.

Taking Tafinlar in combination with trametinib

Take Tafinlar in combination with trametinib:
exactly as your healthcare provider tells you.
Swallow the Tafinlar capsules and the trametinib tablet, with a full glass of water.
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 more than one dose of trametinib a day.
Do not change your dose or stop Tafinlar in combination with trametinib unless your healthcare provider tells you.

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.
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, 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.
If you take too much Tafinlar or trametinib, immediately call your doctor, the Poisons Information Centre, or go to the nearest hospital.
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.
Your doctor may do some tests (from time to time to make sure the medicine is working and to prevent unwanted side effects.

Signs you may need to look out for

Some people taking Tafinlar develop other conditions, which can be serious.
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 another medicine called trametinib) can cause serious bleeding problems 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 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 medicine
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
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 with food.
You must take it on an empty stomach.
Do NOT take the morning and evening doses of Tafinlar at the same time.
Do NOT take more Tafinlar capsules than your doctor has recommended.
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.
Do NOT stop taking your medicine, or lower the dosage, without first checking with your doctor.

Things to be careful of

Be careful:
driving or operating machinery until you know how Tafinlar affects you.
when 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.

Signs you need to look out for

Tell your doctor or pharmacist if you notice any of the following signs:
BLEEDING PROBLEMS
Tafinlar, when given alone or in combination with trametinib, can cause serious bleeding problems that may lead to death, especially in your brain or stomach.
Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:
headaches, dizziness, or weakness
coughing up of blood or blood clots
vomit containing blood or that looks like "coffee grounds"
bleeding from nose
red or black stools that look like tar
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 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 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 (either for the first time or if they get worse), tell your doctor or nurse as soon as possible:
new wart
skin sore or reddish bump that bleeds or does not heal
change in size or colour of a mole
EYE PROBLEMS
Tafinlar can cause an eye problem called uveitis which could damage your vision if it is not treated. Uveitis may develop rapidly and the 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, 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 YOUR 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)
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.
Some side effects may not give you any symptoms and can only be found when tests are done. Some of these side effects include:
Low phosphorus in the blood (common)
Increased blood sugar (common).

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):
Bleeding (haemorrhage)
Fever
Rash, dry skin, itching, acne-like problems
High blood pressure
Cough
Stomach ache
Feeling sick (nausea), or being sick (vomiting)
Diarrhoea
Constipation
Lack of energy, feeling weak
Nasal inflammation
Urinary tract infection
Headache
Decreased appetite
Chills
Dizziness
Joint pain, muscle pain, or pain in the hands or feet
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 hands or feet
Very common side effects that may show up in your blood tests
low levels of :
white blood cells
haemoglobin (oxygen-carrying pigment)
abnormal blood test results related to the liver
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
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
Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)
UNCOMMON SIDE EFFECTS
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.
Some side effects may not give you any symptoms and can only be found when tests are done. Some of these side effects include:
Decreased platelet count (cells that help blood to clot) - common
Low levels of sodium in the blood - common
Increase in some substances (enzymes) produced by the liver - common
Decrease in the number of red blood cells (anaemia) - common. If you have this condition you may experience some of the following symptoms:
Tiredness
Headaches
Shortness of breath when exercising
Dizziness
Looking pale
Decrease in a type of white blood cells (leukopenia) - common. If you have this condition, you may experience some of the following symptoms:
frequent infections
fever
severe chills
sore throat or
mouth ulcers.
Increase in an enzyme found mainly in heart, brain, and skeletal muscle (creatine phosphokinase) - common
Increase in blood sugar level - common
Low levels of phosphate in the blood - common.
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 your 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.

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.

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 July 2015.
For internal use only
(taf100715c based on PI taf100715i)