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 taking BRAFTOVI?
BRAFTOVI contains the active ingredient encorafenib. BRAFTOVI can be used:
in combination with a medicine called binimetinib (MEKTOVI®) to treat adult patients with a type of skin cancer called melanoma, which has spread
to other parts of the body, or cannot be removed by surgery; or
in combination with a medicine called cetuximab to treat adults with cancer of the
large intestine (colorectal cancer) that has been previously treated with other anticancer
medicines.
2. What should I know before I use BRAFTOVI?
Do not use if you have ever had an allergic reaction to Braftovi 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 BRAFTOVI? in the full CMI.
3. What if I am taking other medicines?
4. How do I use BRAFTOVI?
Melanoma - The recommended dose of BRAFTOVI, when taken in combination with MEKTOVI,
is six 75 mg capsules once daily (corresponding to a daily dose of 450 mg).
Colorectal cancer - The recommended dose of BRAFTOVI, when taken in combination with
cetuximab is four 75 mg capsules once daily (corresponding to a daily dose of 300
mg).
Swallow the capsules whole with a full glass of water. BRAFTOVI can be taken with
or without food. Avoid grapefruit juice.
5. What should I know while using BRAFTOVI?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using BRAFTOVI.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to
become pregnant before taking BRAFTOVI
Tell your doctor if you experience heart, bleeding, eye, liver or problems, or skin
changes.
|
|
Things you should not do
|
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Do not take BRAFTOVI to treat any other complaints unless your doctor tells you to.
|
|
Driving or using machines
|
BRAFTOVI can affect your ability to drive or use machines.
|
|
Looking after your medicine
|
Keep your BRAFTOVI capsules in their original pack until it is time to take them.
Store below 25°C in a cool and dry place.
|
6. Are there any side effects?
When BRAFTOVI was taken with binimetinib, very common side effects included fatigue,
nausea, diarrhoea, vomiting, problems with vision, stomach pain, joint pain, abnormal
blood test results and muscle pain. When BRAFTOVI was taken with cetuximab, very common
side effects included fatigue, nausea, diarrhoea, acne type rash, rash, stomach pain,
decreased appetite and muscle pain. 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. 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): encorafenib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BRAFTOVI. 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 BRAFTOVI.
Where to find information in this leaflet:
1. Why am I taking BRAFTOVI?
BRAFTOVI contains the active ingredient encorafenib.
BRAFTOVI is an anti-cancer medicine, which belongs to a group of medicines called
‘BRAF inhibitors’.
BRAFTOVI can be used in combination with binimetinib (called MEKTOVI) to treat adult
patients who have a type of skin cancer called melanoma, which has spread to other
parts of the body, or cannot be removed by surgery, and which has a particular change
(mutation) in the gene that produces a protein called BRAF.
BRAFTOVI can also be used in combination with cetuximab to treat adult patients who
have previously been treated with other anticancer medicines, and who have a type
of large intestine cancer (colorectal cancer), which has spread to other parts of
the body, and which has a particular change (mutation) in the gene that produces a
protein called BRAF.
BRAFTOVI can only be used to treat patients whose cancer has one of these particular
mutations in the BRAF gene.
Before you start treatment, your doctor will have tested your tumour to confirm that
it has one of these BRAF mutations.
When BRAFTOVI is used in combination with MEKTOVI or cetuximab, it can slow down or
stop the growth of your cancer.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
BRAFTOVI is not recommended for children and adolescents aged under 18 years. The
safety and efficacy of this medicine has not been established in this age group.
2. What should I know before I take BRAFTOVI?
BRAFTOVI is to be used in combination with either MEKTOVI or cetuximab, therefore
you should also read the CMI for the other medicine you are planning to take.
Warnings
Do not take BRAFTOVI if:
you are allergic to encorafenib, 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
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions such as:
heart problems, including alteration of the electrical activity of your heart (QT
prolongation)
liver problems
kidney problems
bleeding problems, or if you are taking medicines that may increase your risk of bleeding
eye problems
take any medicines for any other condition
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. BRAFTOVI is
not recommended while breast-feeding. It is not known if BRAFTOVI passes into breastmilk.
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 BRAFTOVI and affect how it works. These include:
some medicines to treat fungal infections (such as itraconazole, posaconazole, fluconazole)
some medicines to treat bacterial infections (such as rifampicin, clarithromycin,
telithromycin, erythromycin, penicillin)
medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine)
medicines typically used to treat cancer (such as methotrexate, imatinib)
medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin)
a herbal treatment for depression called St. John’s wort
some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir or dolutegravir
birth control medicines containing hormones
medicines typically used to treat high blood pressure (such as diltiazem, bosentan,
furosemide)
medicines used to treat an uneven heartbeat such as amiodarone.
These medicines may be affected by BRAFTOVI or these medicines may affect how well
BRAFTOVI works. You may need different amounts of your medicines, or you may need
to take different medicines.
Keep a list of the medicines you take so you can show it to your doctor, nurse or
pharmacist when you get a new medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BRAFTOVI.
4. How do I take BRAFTOVI?
Instructions to open the blister:
Do not push the capsule through the blister.
Separate one blister cell by bending it and gently tearing along the perforations.
Carefully peel off the blister foil starting at the corner labelled with an arrow.
Gently remove the capsule.
How much to take
Always take BRAFTOVI exactly as your doctor has prescribed.
The recommended dose of BRAFTOVI to treat melanoma, when taken in combination with
MEKTOVI, is six 75 mg capsules once daily (corresponding to a daily dose of 450 mg).
The recommended dose of BRAFTOVI to treat colorectal cancer, when taken in combination
with cetuximab, is four 75 mg capsules once daily (corresponding to a daily dose of
300 mg).
Be aware that your dose of BRAFTOVI may change during treatment, depending on your
response to treatment.
If you have liver or kidney problems, your doctor may start you on a lower dose of
BRAFTOVI. If you experience serious side effects (such as skin, heart, liver, eye
or bleeding problems), your doctor may lower the dose of BRAFTOVI, or stop treatment
temporarily or permanently.
Follow the instructions provided and use BRAFTOVI until your doctor tells you to stop.
When to take BRAFTOVI
Swallow the capsules whole with a full glass of water.
BRAFTOVI can be taken with or without food. Avoid grapefruit juice.
If vomiting occurs at any time after taking the capsules, do not take an additional
dose. Take the next dose as scheduled.
Continue taking BRAFTOVI for as long as your doctor tells you to. Do not stop unless
your doctor advises you to.
If you forget to take BRAFTOVI
If you miss your dose at the usual time, the missed dose is less than 12 hours late,
take it as soon as you remember.
If the missed dose is more than 12 hours late, skip that dose and take your next dose
at the usual time. Then go back to taking your capsules as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose 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 BRAFTOVI
If you think that you have used too much BRAFTOVI, 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 BRAFTOVI?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking BRAFTOVI.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
BRAFTOVI.
If you are going to have surgery, tell the surgeon or that you are taking BRAFTOVI.
If you become pregnant while taking BRAFTOVI, tell your doctor immediately.
If you are a woman who could become pregnant, you must use effective birth control
(contraception) while you are taking BRAFTOVI, and you must continue to use effective
contraception for at least 1 month after taking your last dose.
Birth control medicines containing hormones (such as pills, injections, patches, implants
and certain intrauterine devices (IUDs) which release hormones) may not work as well
as expected while you are taking BRAFTOVI. You will need to use another reliable method
of birth control such as a barrier method (e.g. condom) to prevent falling pregnant
while you are taking BRAFTOVI. Ask your doctor, pharmacist or nurse for advice.
Tell your doctor if you are breastfeeding while being treated with BRAFTOVI.
Call your doctor straight away if you experience the following while you are taking
BRAFTOVI:
Skin changes
Tell your doctor immediately if you detect any skin changes including new warts, skin
soreness, reddish bumps which bleed or don’t heal, or any changes in the size or colour
of a mole.
BRAFTOVI may cause other types of skin cancer such as cutaneous squamous cell carcinoma.
New melanoma lesions may also occur while taking BRAFTOVI.
Your doctor will periodically check for new cancers on your skin and inside your body
before, during and after your treatment with BRAFTOVI.
Heart problems
BRAFTOVI may lower the amount of blood pumped by your heart, alter the electrical
activity of your heart, or make existing heart problems worse. Your doctor will run
tests to check that your heart is working properly before and during your treatment
with these medicines.
Bleeding problems
BRAFTOVI may cause serious bleeding problems. Tell your doctor immediately if you
have any signs of bleeding.
Eye problems
BRAFTOVI may cause serious eye problems. Your doctor will examine your eyes for any
new or worsening problems with your sight while you are taking these medicines.
Liver problems
BRAFTOVI may increase the amounts of liver enzymes in your blood. Your doctor will
run blood tests to monitor your liver function before and during treatment.
Kidney problems
BRAFTOVI may alter your kidney activity (often it may cause abnormal blood tests,
but more rarely it can cause dehydration and vomiting, or kidney failure). Your doctor
will run blood tests to monitor your kidneys before and during treatment. Drink plenty
of fluids during treatment. Tell your doctor immediately if you vomit and become dehydrated.
If you experience the following symptoms, contact your doctor immediately as this
can be a life-threatening condition: nausea, shortness of breath, irregular heartbeat,
muscular cramps, seizures, clouding of urine, decrease in urine output and tiredness.
These may be caused by a group of metabolic complications that can occur during treatment
of cancer that are caused by the breakdown products of dying cancer cells (Tumour
lysis syndrome (TLS)) and can lead to changes in kidney function
Remind any doctor, dentist or pharmacist you visit that you are using BRAFTOVI. Keep
all of your doctor's appointments so that your progress can be checked.
Things you should not do
Do not take BRAFTOVI to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if their symptoms seem similar to yours
or they have the same condition as you.
Do not stop taking your medicine or lower the dosage
without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BRAFTOVI
affects you.
BRAFTOVI can affect your ability to drive or use machines. If you experience any problems
with your vision, or any other side-effects that may affect your ability, avoid driving
or using machines. Talk to your doctor if you are not sure if you should drive.
Looking after your medicine
Keep your BRAFTOVI capsules in their original pack until it is time to take them.
Keep your BRAFTOVI capsules in a place where the temperature stays below 25°C.
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.
When BRAFTOVI was taken with MEKTOVI by patients with melanoma, the following side
effects were reported.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Head and neurology related:
problems with nerves that can cause pain, loss of sensation or tingling in hands and
feet
headache
dizziness
fever
fatigue
changes in the way things taste
weakness and paralysis of the face muscles (facial paresis)
Bleeding related:
reduced red blood cell count (anaemia)
bleeding at various sites in the body
blood clots
Heart related:
high blood pressure
abnormal blood test results related to blood creatine kinase, indicating damage to
the heart and muscle
Eyes related:
problems with your vision (visual impairment)
inflammation of the eye (uveitis
Gastrointestinal related:
stomach pain
diarrhoea
being sick (vomiting)
feeling sick (nausea)
constipation
abnormal blood test results for liver function
inflammation of the colon (colitis)
kidney failure
abnormal kidney test results (creatinine elevations)
abnormal blood test results for liver function (blood alkaline phosphatase)
abnormal blood test results for pancreas function (amylase, lipase)
inflammation of the pancreas (pancreatitis) causing severe abdominal pain
Muscle related:
joint pain (arthralgia)
muscle pain (myalgia), weakness or spasm
back pain
pain in the hands and feet
Skin and hair related:
itching
dry skin
abnormal hair loss or thinning (alopecia)
thickening of the outer layers of the skin
some types of benign (non-cancerous) skin tumours such as skin papilloma
type of skin cancer such as basal cell carcinoma
redness, chapping or cracking of the skin
inflammation of the fatty layer under the skin, symptoms include tender skin nodules
skin rash with flat discoloured area or raised bumps like acne (dermatitis acneiform)
redness, skin peeling or blisters on hands and feet (called palmar-plantar erythrodysaesthesia
or hand and foot syndrome)
increased skin sensitivity to sunlight
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Heart related:
BRAFTOVI can affect the strength with which your heart pumps blood into your arteries
or makes existing heart problems worse. Signs and symptoms can include:
feeling dizzy, tired or lightheaded
shortness of breath
feeling like your heart is pounding, racing or beating irregularly
swelling in the legs
Bleeding related:
headaches, dizziness or weakness
coughing up of blood or blood clots
vomit containing blood or that looks like “coffee grounds”
red or black stools that look like tar
passing blood in the urine
stomach (abdominal) pain
unusual vaginal bleeding
blood clots
Allergy related:
swelling of the hands or feet (peripheral oedema), localised swelling
allergic reaction that may include swelling of the face and difficulty breathing
Other skin cancers related:
BRAFTOVI may cause other types of skin cancer such as cutaneous squamous cell carcinoma
or new melanomas. Usually these skin cancers can be removed with surgery.
Tumour lysis syndrome
Braftovi can cause a rapid breakdown of cancer cells which in some people may be fatal.
Symptoms may include nausea, shortness of breath, irregular heartbeat, muscular cramps,
seizures, clouding of urine, decrease in urine output and tiredness.
|
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.
|
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 BRAFTOVI contains
|
Active ingredient
(main ingredient)
|
50 or 75 mg of encorafenib
|
|
Other ingredients
(inactive ingredients)
|
Capsule fill:
copovidone
poloxamer
microcrystalline cellulose
succinic acid
crospovidone
colloidal anhydrous silica
magnesium stearate
Capsule shell:
gelatin
titanium dioxide
iron oxide red
iron oxide yellow
iron oxide black
Printing ink:
shellac
iron oxide black
propylene glycol
|
|
Potential allergens
|
No
|
Do not take this medicine if you are allergic to any of these ingredients.
What BRAFTOVI looks like
BRAFTOVI 50 mg hard capsules are supplied in blister packs of 28 capsules (7 strips
of 4 capsules).
The 50 mg capsules have an orange opaque cap and a flesh-coloured opaque body, with
a stylised “A” printed on the cap and “LGX 50 mg” printed on the body.
50 mg: AUST R 295764
BRAFTOVI 75 mg hard capsules are supplied in blister packs of 42 capsules (7 strips
of 6 capsules).
The 75 mg capsules have a flesh-coloured opaque cap and a white opaque body, with
a stylised “A” printed on the cap and “LGX 75 mg” printed on the body.
75 mg: AUST R 295441
Who distributes BRAFTOVI
Pierre Fabre Australia Pty Limited
Level 7, 32 Walker St
North Sydney, NSW 2060
® = Registered Trademark
This leaflet was prepared in September.
Internal document code
(Aus Braftovi CMI v9 based on Aus Braftovi PI v12)