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.
1. Why am I using COTELLIC?
COTELLIC contains the active ingredient cobimetinib. COTELLIC is used to treat a type
of skin cancer called melanoma that has spread to other parts of the body and cannot
be removed by surgery. For more information, see Section
1. Why am I using COTELLIC? in the full CMI.
2. What should I know before I use COTELLIC?
Do not use if you have ever had an allergic reaction to COTELLIC 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 COTELLIC? in the full CMI.
3. What if I am taking other medicines?
4. How do I use COTELLIC?
Take COTELLIC exactly as prescribed by your doctor. The recommended dose is three
tablets (a total of 60mg) once a day.
COTELLIC is taken once daily for 21 days followed by a 7 day treatment break (no medicine)
in a 28 day cycle. Start your next COTELLIC treatment cycle after the 7 day treatment
break.
More instructions can be found in Section
4. How do I use COTELLIC? in the full CMI.
5. What should I know while using COTELLIC?
|
Things you should do
|
Remind any doctor (including a surgeon or anaesthetist), dentist or pharmacist you
visit that you are using COTELLIC.
Tell your doctor straight away if you become pregnant or have changes to your vision
while taking COTELLIC.
Check your skin and tell your doctor right away about any changes. Avoid going out
in the sun.
Avoid drinking grapefruit juice.
Tell your doctor if you feel your medicine is not helping your condition.
|
|
Things you should not do
|
Do not stop taking COTELLIC or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how COTELLIC affects you.
If COTELLIC affects your vision, consult your doctor before driving or operating machinery.
COTELLIC may affect your vision.
|
|
Looking after your medicine
|
Keep your tablets in the blister pack until it is time to take them.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not store COTELLIC in the bathroom or near a sink. Do not leave it on a window
sill or in the car.
|
6. Are there any side effects?
This medicine helps most people who have melanoma, but it may have unwanted side effects
in some people (see the full CMI for more details). Tell your doctor or pharmacist
if you notice any of the following and they worry you. Common side effect may include
diarrhoea, nausea, vomiting, fever, chills, dehydration, anaemia, sunburn or sun sensitivity,
skin problems including rashes, spots, itching, thickened areas of the skin, painful
red lumps or warts. Tell your doctor or nurse immediately or go to the nearest hospital
Emergency Department if you experience signs or symptoms of a serious allergic reaction
such as swelling of the face, lips, tongue or other parts of the body, shortness of
breath or difficulty breathing, rash, itching or hives on the skin. Some other serious
side effects may include blisters or peeling skin, muscle aches/spasms/weakness, dark/reddish
urine, bleeding, dizziness, heart problems and/or vision problems.
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
Active ingredient(s):
cobimetinib (kho-bee-meh-tin’ib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using COTELLIC. 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 COTELLIC.
Where to find information in this leaflet:
1. Why am I using COTELLIC?
COTELLIC contains the active ingredient cobimetinib. COTELLIC is belongs to a group of medicines called anti-neoplastic (or anti-cancer)
agents.
COTELLIC is used to treat a type of skin cancer called melanoma that has spread to
other parts of the body and cannot be removed by surgery.
COTELLIC is used in combination with another medicine called ZELBORAF® (containing the active ingredient vemurafenib).
COTELLIC can only be used if your melanoma has a change (mutation) in the BRAF gene.
Your doctor will have tested you for this gene mutation to make sure COTELLIC is suitable
for you. The gene mutation has been shown to be involved in the development of melanoma.
COTELLIC targets the "MEK" protein and ZELBORAF targets the changed "BRAF" protein.
Both proteins are important in controlling cancer cell growth.
When used together, these medicines slow down the growth of your cancer.
Ask your doctor if you have any questions about why COTELLIC has been prescribed for
you. Your doctor may have prescribed it for another reason.
COTELLIC is not addictive. This medicine is available only with a doctor's prescription.
2. What should I know before I use COTELLIC?
Warnings
As COTELLIC is taken together with ZELBORAF, also read the Consumer Medicine Information
for ZELBORAF before you take these medicines.
Do not use COTELLIC if:
1. You are allergic to cobimetinib (the active ingredient), or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
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.
2. The package is torn or shows signs of tampering
3. The expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed it may not work as well.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
1.
You have any eye problems
It is important your doctor is aware of any eye problems. You should see your doctor
immediately for an eye exam if you experience new or worsening loss in vision or other
eye problems while you are taking COTELLIC.
2.
You have any heart problems
Your doctor should do tests before you start taking COTELLIC and during your treatment
to check the ability of the heart to pump blood sufficiently.
3.
You have any liver problems
Your doctor will perform some blood tests before and during your treatment to monitor
your liver function. If necessary, your doctor may decide to reduce your dose, interrupt
your treatment temporarily or stop it altogether.
4.
You have any medical conditions that increase your risk of bleeding
5.
You have any muscle problems
6.
You have any problems with your kidneys
7.
You have allergies to any other medicines, foods, preservatives or dyes
If you have not told your doctor about any of the above, tell him/her before you start
taking COTELLIC.
Safety and effectiveness of COTELLIC in children younger than 18 years have not been
established.
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.
It is not known whether COTELLIC is harmful to an unborn baby when taken by a pregnant
woman. COTELLIC is not recommended during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether COTELLIC passes into breast milk. Your doctor will discuss
the risks and benefits of taking COTELLIC if you are breast feeding or plan to breast
feed.
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 COTELLIC and affect how it works. These include:
itraconazole, voriconazole, posaconazole, fluconazole and miconazole, medicines used
to treat fungal infections
clarithromycin, erythromycin and rifampicin, medicines used to treat bacterial infections
ritonavir, cobicistat, lopinavir, and fosamprenavir, medicines used to treat HIV infection
amiodarone, a medicine to treat a heart rhythm problems
diltiazem and verapamil, medicines used to treat high blood pressure
imatinib, a medicine used to treat cancer
carbamazepine and phenytoin, medicines used to treat seizures
St. John’s Wort, a herbal medicine used to treat depression.
These medicines may be affected by COTELLIC or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this 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 COTELLIC.
4. How do I use COTELLIC?
How to use COTELLIC
Take COTELLIC exactly as your doctor has prescribed.
The recommended dose is three tablets (a total of 60 mg) once a day.
COTELLIC is taken once daily for 21 days followed by a 7 day treatment break (no drug)
in a 28 day cycle. Start your next COTELLIC treatment cycle after the 7 day treatment
break.
It is recommended you take ZELBORAF, as prescribed, during both the COTELLIC treatment
phase AND the 7 day COTELLIC treatment break.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you experience any side effects, your doctor may need to lower the dose to carry
on your treatment.
Swallow the tablets whole with a glass of water.
You can take COTELLIC with or without food
If you vomit after taking COTELLIC, do not take the same dose again. Continue to take
COTELLIC as normal, the next day.
How long you will be treated with COTELLIC depends on how you are responding to treatment.
Your doctor will discuss this with you.
Continue taking COTELLIC until your doctor tells you to stop.
When to use COTELLIC
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
If you vomit after taking COTELLIC
Do not take the same dose again. Continue to take COTELLIC as normal, the next day.
If you forget to use COTELLIC
If it is more than 12 hours before your next dose, take the missed dose as soon as
you remember.
If it is less than 12 hours before your next dose, skip the missed dose. Then take
the next dose at the usual time.
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 pharmacist for some
hints.
If you use too much COTELLIC
If you think that you or anyone else has taken too much COTELLIC, you may need urgent
medical attention. Keep the following telephone numbers handy.
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 using COTELLIC?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking COTELLIC.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
COTELLIC.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Women who can get pregnant should use two effective forms of contraception to prevent
pregnancy during treatment and for at least 3 months following the final dose.
Check your skin and tell your doctor right away about any changes.
Avoid going out in the sun.
If you are taking COTELLIC you may become more sensitive to sunlight and get symptoms
of sunburn (such as redness, itching, swelling and blistering) more easily or get
sunburns that can be severe.
To help protect against sunburn, if you do plan to go into the sun wear clothing which
protects your skin, including head, face, arms and legs. Use a broad spectrum (UVA/UVB)
sunscreen and lip balm (minimum of SPF 30+, re-applied every 2 - 3 hours).
Avoid taking COTELLIC with grapefruit juice. Grapefruit juice can increase the amount
of COTELLIC in your blood.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Tell your doctor if you feel your medicine is not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Call your doctor straight away if you:
Become pregnant while taking COTELLIC.
You have eye pain, swelling, redness, blurred vision, loss of vision, changes in colour,
seeing a blurred outline around objects or other vision changes during your treatment.
You should have your eyes immediately examined by your doctor if you experience eye
problems while you are taking COTELLIC.
Notice changes in your skin, such as any crusty, non-healing sores; small lumps that
are red, pale or pearly in colour; or new spots, freckles or any moles changing in
colour. You may develop new skin cancers or skin lesions which are different from
melanoma while taking COTELLIC. These cancers are usually removed by surgery and you
can continue your treatment.
Things you should not do
Do not stop using this medicine suddenly without first checking with your doctor.
Do not use COTELLIC to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how COTELLIC
affects you.
Be careful driving or operating machinery until you know how COTELLIC affects you.
If COTELLIC affects your vision, consult your doctor before driving or operating machinery.
COTELLIC may affect your vision.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the blister pack they may not keep well.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not store COTELLIC or any other medicine in the bathroom, near a sink, on a window
sill or in the car. Heat and dampness can destroy some medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
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
|
Less serious side effects
|
What to do
|
|
fever
chills
Signs and symptoms of low iron in your blood (anaemia):
tiredness
headaches
being short of breath when exercising
dizziness
looking pale
Signs and symptoms of dehydration:
dry or sticky mouth
low or no urine output
urine looks dark yellow
no tears
sunken eyes
Signs and symptoms of skin problems:
sunburn or sun sensitivity
rashes
spots
itching
dry or scaly skin
hardened or thickened areas of the skin
painful red lumps or warts
Signs and symptoms of respiratory problems:
coughing
Signs and symptoms of gastro-intestinal problems:
diarrhoea
nausea
vomiting
Some side effects can only be found when your doctor performs tests from time to time
to check your progress, for example:
increased levels of liver enzymes or sugars in the blood
decreased levels of sodium or phosphate in the blood
increased levels of blood creatine phosphokinase, a marker of tissue damage
increased blood pressure (hypertension)
|
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
|
|
Signs and symptoms of severe skin problems:
a rash that covers a large area of your body
blisters
peeling skin
Signs and symptoms of muscle damage:
muscle aches
muscle spasms and weakness
dark, reddish urine
Signs and symptoms of a serious bleeding problem:
red or black stools that look like tar
blood in your urine or stools
unusual vaginal bleeding
headaches, dizziness, or feeling weak
Signs and symptoms of an allergic reaction:
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
Signs and symptoms of heart problems:
persistent coughing or wheezing
shortness of breath
difficulty breathing
tiredness
increased heart rate
swelling of your ankles and feet
Signs and symptoms of severe eye or vision problems:
blurred vision, loss of vision or other vision changes
changes in colour
seeing a blurred outline around objects
eye pain, swelling or redness
|
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 COTELLIC contains
|
Active ingredient
(main ingredient)
|
cobimetinib
(as a hemifumarate salt)
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose (460)
croscarmellose sodium
magnesium stearate
polyvinyl alcohol
titanium dioxide (171)
macrogol 3350
purified talc
|
|
Potential allergens
|
lactose monohydrate
|
Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
What COTELLIC looks like
COTELLIC tablets are round and white with "COB" debossed on one side. (AUST R 237017).
Who distributes COTELLIC
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW 2000
AUSTRALIA
Medical enquiries: 1800 233 950
This leaflet was prepared in 20 April 2023