Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using TAFINLAR?
TAFINLAR contains the active ingredient dabrafenib. In adult patients TAFINLAR is
used to treat certain types of skin cancer (melanoma), thyroid cancers and lung cancers;
prevent the melanoma coming back if removed by surgery. In children 1 year and older,
TAFINLAR is used to treat brain tumours, following other treatments. For more information,
see Section
1. Why am I using TAFINLAR? in the full CMI.
2. What should I know before I use TAFINLAR?
Do not use if you have ever had an allergic reaction to dabrafenib or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use TAFINLAR? in the full CMI.
3. What if I am taking other medicines?
4. How do I use TAFINLAR?
TAFINLAR should be taken at least 1 hour BEFORE eating or 2 hours AFTER eating.
In adults, the usual total dose of TAFINLAR is 150 mg twice each day (each dose being
12 hours apart).
TAFINLAR capsules: Take each 150 mg dose on an empty stomach, either as two 75 mg
capsules or three 50 mg capsules: one after the other swallowed whole with a full
glass of water
In children, dosage is based on body weight, and is taken twice each day.
TAFINLAR dispersible tablets are to be taken as a liquid oral solution only. Follow
the Instructions for Use in the pack.
5. What should I know while using TAFINLAR?
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Things you should do
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Remind any doctor, dentist, nurse, or pharmacist you visit that you are using TAFINLAR
Keep all your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do NOT take TAFINLAR with food.
Do NOT stop using TAFINLAR suddenly or change the dose instructed by your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how TAFINLAR
affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your medicine in the bottle until it is time to use them.
Keep capsules and dispersible tablets in a cool dry place where the temperature stays
below 30°C.
Once tablets are dispersed in water, use within 30 minutes.
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6. Are there any side effects?
Common side effects include feeling sick, vomiting, headache, changes to appetite,
lack of energy, joint pain, hair loss, skin changes including redness, dryness, itching,
raised bumps, rash, tingling, weakness, or sensation loss in hands and feet. Serious
side effects include difficulty breathing or wheezing, trouble swallowing, swollen
hands, feet, or face; chest pain, severe tummy pain, less wee than normal, changes
to colour of moles, fever, unexplained bleeding, vision changes, confusion, decreased
urine output, muscle spasms, irregular heartbeat. For more information, including
what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring due to approval of an extension
of indication. This will allow quick identification of new safety information. You
can help by reporting any side effects you may get. You can report side effects to
your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
[dabrafenib (as mesilate)] (da-braf-e-nib mee-sill-ate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TAFINLAR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TAFINLAR.
Where to find information in this leaflet:
1. Why am I using TAFINLAR?
TAFINLAR contains the active ingredient dabrafenib.
TAFINLAR belongs to a group of medicines called "selective BRAF-inhibitors."
TAFINLAR is used to:
Treat adults with the following types of cancers that have spread to other parts of
the body:
- skin cancers called melanoma
- thyroid cancers called anaplastic thyroid cancer (ATC)
- lung cancers called non-small cell lung cancer (NSCLC)
Prevent melanoma from coming back after the melanoma has been removed by surgery in
adult patients.
Treat children 1 year and older with a brain tumour (glioma), following other treatments.
These cancers have changes (mutations) in a gene called "BRAF" that may have caused
your cancer to grow. TAFINLAR slows down or stops the growth of your cancer.
TAFINLAR can be used by itself or together with another medicine called MEKINIST (containing
trametinib).
If you are taking these medicines together, please read the MEKINIST Consumer Medicine
Information as well as this one carefully.
2. What should I know before I use TAFINLAR?
Monitoring
Before you take TAFINLAR, your doctor will take tumour tissue samples to check whether
TAFINLAR is suitable for you.
Your doctor may also take blood samples to monitor your liver while you are taking
TAFINLAR.
Warnings
Do not use TAFINLAR if:
You are pregnant
You are allergic to "dabrafenib", or any other ingredient listed at the end of this
leaflet (symptoms of an allergic reaction can include difficulty breathing, wheezing,
swelling of the face, lips or tongue and rash.
You are under 12 months of age. It is not known whether it is safe and effective in
this younger group of patients.
Check with your doctor if you have:
Liver problems
Kidney problems
Diabetes or high levels of sugar in your blood
Heart problems
Eye problems
Lung or breathing problems
Skin problems
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may become pregnant or are planning
to have a baby, ask your doctor, pharmacist, or health care provider for advice before
taking this medicine.
If you do become pregnant while you are taking TAFINLAR, tell your doctor immediately.
Your doctor will discuss with you the potential risk(s) of taking TAFINLAR during
pregnancy or breast-feeding. TAFINLAR alone or in combination with MEKINIST are not
recommended during pregnancy or while breastfeeding.
Birth control requirements
Women taking TAFINLAR
If you are a woman who could become pregnant, you must use good birth control while
you are taking TAFINLAR and for:
at least two weeks after you stop taking it
OR
at least 16 weeks following the last dose of MEKINIST (when taking in combination
with TAFINLAR)
Birth control methods containing hormones (such as pills, injections or patches) may
not work as well while you are taking TAFINLAR.
You need to use another good method of birth control, so you don't become pregnant
while you are taking TAFINLAR.
Ask your doctor, healthcare provider, pharmacist, or nurse about options for good
birth control or for advice.
Men taking TAFINLAR
You may have a lower sperm count while you are taking TAFINLAR. Your sperm count may
not return to normal levels after you stop taking TAFINLAR.
Male patients (including those that have had a vasectomy) with female partners who
are or may become pregnant, should use condoms during sexual intercourse while taking
TAFINLAR and for at least 2 weeks after stopping TAFINLAR.
If taking TAFINLAR in combination with MEKINIST, male patients should use condoms
during sexual intercourse while on TAFINLAR and for at least
16
weeks after stopping both TAFINLAR and MEKINIST.
If you have any further questions on the effect of this medicine on sperm count, ask
your doctor or nurse.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
Some medicines may interfere with TAFINLAR and affect how it works such as:
Birth control medicines that use hormones
Warfarin (a medicine used to thin blood and prevent clots)
Medicines to treat fungal infections (such as ketoconazole, itraconazole, voriconazole,
posaconazole)
Antibiotics such as clarithromycin, telithromycin or rifampicin
Medicines that cause a low immune system
Medicines that decrease the amount of stomach acid in your stomach (for example: omeprazole,
esomeprazole, rabeprazole, pantoprazole, lansoprazole, ranitidine, cimetidine, famotidine,
nizatidine or common antacids.
Medicines that lower fats in the body such as gemfibrozil
Medicines that decrease swelling such as dexamethasone
Medicines used to treat HIV such as ritonavir, saquinavir and atazanavir
Medicines used to treat seizures phenytoin, phenobarbital, or carbamazepine
Some anti-depressant medicines such as nefazodone and the herbal St John's wort (Hypericum
perforatum)
Medicines used to treat high levels of cholesterol such as rosuvastatin.
4. How do I take TAFINLAR?
How much to take
Adults
The usual total dose of TAFINLAR is 150 mg twice each day.
Follow the instructions provided and use TAFINLAR until your doctor tells you to stop.
You must take 2 TAFINLAR doses each day.
Take each 150 mg dose on an empty stomach as either:
Two 75 mg capsules, or
Three 50 mg capsules.
Children (1 year and above)
The daily dose is based on the body weight and will be determined by their doctor.
Follow the instructions provided and use TAFINLAR until your doctor tells you to stop.
Do not take more TAFINLAR than your doctor has recommended.
When to take TAFINLAR
Take the first dose of TAFINLAR in the morning and take the second dose of TAFINLAR
in the evening, approximately 12 hours later.
Take the morning and evening doses at about the same time each day.
How to take TAFINLAR CAPSULES
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.
Take TAFINLAR on an empty stomach
TAFINLAR should be taken either at least:
1 hour BEFORE eating
If taking TAFINLAR BEFORE something to eat or drink, take it and then wait at least
1 (one) hour before having any food or drink
OR
2 hours AFTER eating
If taking TAFINLAR AFTER eating a meal or having a drink, wait at least two (2) hours
before taking TAFINLAR.
How to take TAFINLAR DISPERSIBLE TABLETS
TAFINLAR dispersible tablets are to be taken as a liquid oral suspension only and
should not be swallowed whole, chewed, or crushed.
If you are taking TAFINLAR dispersible tablets, please follow Instructions for Use
in the carton on how to prepare and take TAFINLAR dispersible tablets. Talk to your
doctor or pharmacist if you are not sure.
Give TAFINLAR on an empty stomach
TAFINLAR should be given either at least:
1 hour BEFORE eating
If taking TAFINLAR BEFORE something to eat or drink, give it and then wait at least
1 (one) hour before having any food or drink
OR
2 hours AFTER eating
If giving TAFINLAR AFTER eating a meal or having a drink, wait at least two (2) hours
before giving TAFINLAR
If you forget to use TAFINLAR
TAFINLAR should be used regularly at the same time each day. If the missed dose of TAFINLAR 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.
Do not take a double dose to make up for the dose that you missed.
If you use too much
If you think that you have used too much TAFINLAR (or MEKINIST, if taking them together),
you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking TAFINLAR?
Things you should do
Use additional contraception for both men and women to avoid pregnancy while taking
TAFINLAR and do this for 2 weeks after stopping TAFINLAR or 16 weeks after stopping
MEKINIST and TAFINLAR (if using both medicines together)
If you become pregnant while taking TAFINLAR, tell your doctor immediately
Keep all your doctor's appointments so that your progress can be checked
Have the blood tests your doctor tells you to have
Have your eyes checked regularly.
Call your doctor straight away if you:
Get a high fever
Signs of a fever may include: a temperature of 38°C or more, severe chills, shivering,
thirst or dehydration, feeling dizzy, faint, or as if you're going to be sick.
Experience multiple symptoms such as irregular heartbeat, decrease in urine output,
confusion, severe nausea and vomiting, shortness of breath, muscle cramps or spasms
at the same time which may be signs of tumour lysis syndrome or TLS, a condition resulting
from a fast breakdown of cancer cells.
Things you should not do
Do not stop taking this medicine suddenly.
Do not take TAFINLAR with food.
Additional Tests
Your doctor may do some blood tests such as checking blood cells (white blood cells,
red blood cells and platelets) and electrolytes (e.g. sodium, phosphorus) in your
body from time to time to make sure TAFINLAR is working and to prevent unwanted side
effects. Your eyes will also be checked regularly.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TAFINLAR
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your capsules and dispersible tablets in the bottle until it is time to take
them
Store below 30°C (capsules). Store below 25°C (dispersible tablets).
Do not remove the desiccant from the capsule bottle or canisters from the dispersible
tablet bottle (material that keeps the medicine dry).
Once dispersible tablets are dispersed, solution should be drunk within 30 minutes.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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TAFINLAR alone
Hair problems
Loss or thinning of hair
Skin problems
Red, dry, itchy, or irritated skin
Sunspots, skin tags, warts
Painful bumps or other changes
Sensitive skin
Tummy problems
Vomiting, minor tummy pain,
Constipation
General wellness
Lack of energy, feeling sick, headache
Cough, sore throat, runny nose
Flu like symptoms such as feeling cold, feeling hot, feeling weak, aching muscles,
tiredness
Changes to appetite
Irritability, excessive thirst
Limb problems
Pain, tingling, loss of feeling or weakness in hands/feet.
Kidney problems
More frequent wee
TAFINLAR and MEKINIST together
Skin problems
Red, dry, itchy, cracked, or irritated skin
Sunspots, skin tags, warts
Painful bumps or other changes
Sensitive skin
General wellness
Lack of energy, feeling sick, headache, feeling lightheaded
Cough, sore throat, runny nose
Flu like symptoms: feeling cold, hot or weak, muscle ache/spasm
Changes to appetite
Irritability, excessive thirst/dry mouth
Night sweats, excessive sweating
Weight increased (in children)
General pain
Muscles, joints, hands, or feet, muscle spasm
Kidney problems
More frequent wee or urinary tract infection
Much less wee than normal
Abdominal problems
Vomiting, minor tummy pain
Constipation
Limb problems
Nail disorders and pain
Swelling in the arms, legs, or other part of the body
Pain, tingling, loss of feeling or weakness in hands/feet.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
If these side effects become severe, please tell your doctor, pharmacist or healthcare
provider.
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Serious side effects
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Serious side effects
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What to do
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TAFINLAR alone
Skin problems
Unusual growth of skin cells
Sore skin that doesn't heal
Change in colour or size of mole
Tummy problems
Severe tummy pain
Kidney problems
Changes to the amount of wee when going to the toilet
Unexplained drowsiness, confusion, or feeling sick
Signs of allergic reaction
Trouble breathing/swallowing, dizziness, swelling of face, throat or tongue, itchy
rash, wheezing.
TAFINLAR and MEKINIST together
Signs of infection
Fever, chills, sore throat, painful bumps in your mouth (ulcers)
Bleeding problems
Bloody poo or vomit, coughing up blood, nosebleeds
Sudden bleeding/bruising
Kidney problems
Less wee when going to the toilet
Unexplained drowsiness, confusion, or feeling sick
Red-brown wee or pain when going to the toilet
Fluid buildup eg swollen legs
Skin problems
Severe rash, blisters on the eyes or lips, peeling.
Swollen lymph nodes
Tummy problems
Severe, sudden tummy pain or cramps
Eye problems
Loss of or blurred vision, flashing light sensation, red eyes
Heart problems
Tightness in chest, fast heart rate, flushing or bluish skin
Slow heart rate
Irregular heartbeat
Breathing problems
Painful or troubled breathing
Signs of allergic reaction
Trouble breathing/swallowing, dizziness, swelling of face, throat or tongue, itchy
rash, wheezing.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TAFINLAR contains
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Active ingredient
(main ingredient)
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Dabrafenib (as mesilate)
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Other ingredients - capsules
(inactive ingredients)
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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)
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Potential allergens
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This medicine does not contain lactose, sucrose, gluten, tartrazine, or any other
azo dyes.
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Other ingredients - dispersible tablets
(inactive ingredients)
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Mannitol
Microcrystalline cellulose
Crospovidone
Hypromellose
Acesulfame potassium
Magnesium stearate
Colloidal anhydrous silica
Artificial berry flavour
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Potential allergens
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This medicine does not contain lactose, gluten, tartrazine, or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What TAFINLAR looks like
TAFINLAR capsules are available in plastic bottles containing 120 capsules. The bottle
has a child resistant closure.
TAFINLAR dispersible tablets are available in plastic bottles containing 210 dispersible
tablets. The bottle has a child resistant closure.
TAFINLAR 50 mg capsules: AUST R 200922
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.
TAFINLAR 75 mg capsules: AUST R 200936
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.
TAFINLAR 10 mg dispersible tablets: AUST R 397093
TAFINLAR 10 mg dispersible tablets are white to slightly yellow, round, biconvex tablets
marked "D" on one side and "NVR" on the other.
Who distributes TAFINLAR
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road,
Macquarie Park NSW 2113
Australia
Telephone 1 800 671 203
® Registered Trademark
This leaflet was prepared in March 2024.
Internal document code: taf120324c based on PI taf120324i.