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Mekinist

trametinib (as dimethyl sulfoxide) tablets
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 Mekinist. It does not contain all the information that is known about Mekinist. 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 Mekinist is used for

Mekinist is a medicine that contains the active ingredient trametinib (as trametinib dimethyl sulfoxide). It is 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.
Mekinist can also be used together with another medicine called dabrafenib. When used together, these two medicines can be used to treat people with melanoma.
Mekinist can only be used to treat melanomas with a change (mutation) in the BRAF gene, so your doctor must take tumour tissue samples first, to test whether Mekinist is suitable for you.
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.
This medicine is available only with a doctor's prescription.
There is not enough information to recommend the use of this medicine for children and adolescents, under the age of 18 years.

Before you take Mekinist

Your doctor may decide to treat your melanoma with Mekinist alone or Mekinist in combination with another medicine dabrafenib.
If you are taking the combination, read the dabrafenib leaflet as well as this leaflet carefully.

When you must not take it

Do not take Mekinist if you have an allergy to:
trametinib (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
If you experience an allergic reaction, stop using the medicine and inform your doctor or pharmacist immediately.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
The expiry date refers to the last day of that month.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor or nurse if you have allergies to any other medicines, foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies.
Tell your doctor or nurse if you have or have had any of the following medical conditions:
any heart problems
such as heart failure or problems with the way your heart beats.
any eye problems
including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the back of the eye (retinal pigment epithelial detachment).
any lung disease
These include the group of diseases that affect the tissues and space around the air sacs of the lungs (interstitial lung disease) and inflammation of the lung (pneumonitis).
any skin problems
including rash or acne-like rash.
If you are taking the combination of Mekinist and dabrafenib, your doctor also needs to know if you have an eye problem called uveitis. The symptoms of uveitis include:
eye redness and irritation
blurred vision
eye pain
increased sensitivity to light
floating spots before the eyes.

Pregnancy and breast-feeding

Tell your doctor or nurse if you are pregnant or plan to become pregnant.
Your doctor can discuss with you the risks and benefits involved.
Mekinist taken alone and in combination with dabrafenib is not recommended for use during pregnancy.
Mekinist can harm an unborn baby.
If you are a woman who could become pregnant, you must use reliable birth control (contraception) while you are taking Mekinist and for 4 months after you stop taking it.
If Mekinist is taken in combination with dabrafenib, non-hormonal contraception should be used.
Birth control methods containing hormones (such as pills, injections, or patches) may not work as well while taking dabrafenib.
You need to use another reliable method of birth control such as condoms if Mekinist is taken in combination with dabrafenib.
If you do become pregnant while you're taking Mekinist tell your doctor or nurse immediately.
Mekinist is not recommended while breast-feeding
It is not known whether the ingredients of Mekinist can pass into breast milk.
If you are breast-feeding, or planning to breast-feed, you must tell your doctor.
It is not recommended that you breast-feed while you are taking Mekinist. You and your doctor will decide whether you will take Mekinist or breast-feed.
If you have not told your doctor about any of the above, tell them before you start taking Mekinist.

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.
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.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Mekinist

Follow all directions given to you by your doctor or pharmacist 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 pharmacist for help.

How much to take

The usual dose of Mekinist is one 2 mg tablet once a day.
Your doctor may decide that you should take a lower dose if you get side effects.
Don't take more Mekinist than your doctor has recommended.

When to take it

Take Mekinist once a day on an empty stomach.
Mekinist should be taken at least:
1 hour before eating
or
2 hours after eating.
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.

How to take it

Swallow the Mekinist tablet whole with a full glass of water.

Taking Mekinist together with dabrafenib

Take Mekinist in combination with dabrafenib exactly as your doctor tells you.
Do not change your dose, or stop Mekinist in combination with dabrafenib unless your healthcare provider tells you.
Take your once daily dose of Mekinist at the same time each day, with either the morning dose or the evening dose of dabrafenib.
Swallow the Mekinist tablet and the dabrafenib capsule, with a full glass of water.
Take the first dose of dabrafenib in the morning, and take the second dose of dabrafenib in the evening, approximately 12 hours later.
Do NOT take:
more than one dose of Mekinist a day, or
the morning and evening doses of dabrafenib at the same time
If you take too much Mekinist or dabrafenib, call your doctor or go to the nearest hospital right away. Take Mekinist tablets and dabrafenib capsules with you when possible.

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

Mekinist taken alone

If the missed dose is:
less than 12 hours late, take it as soon as you remember.
more than 12 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.

Mekinist taken together with dabrafenib

If you miss a dose of Mekinist or dabrafenib, take it as soon as you remember.
Do not make up for missed doses.
Then take your next dose at your regular time.
If it is less than 12 hours to your next scheduled dose of Mekinist, which is taken once daily.
If it is less than 6 hours to your next scheduled dose of dabrafenib, which is taken twice daily.
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)

In Australia, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Mekinist.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using Mekinist

Things you must do

If you are about to be started on any new medicine remind your doctor and pharmacist that you are taking Mekinist.
Tell any other doctors, dentists, 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.

Conditions you may need to look out for

Some people taking Mekinist or Mekinist and dabrafenib together (combination treatment) develop other conditions which can be serious.
You need to know about important signs and symptoms to look out for while you're taking Mekinist.
If you get a high temperature (fever)
Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever (see 'Fever' in Side Effects). A fever is more likely if you are taking the combination treatment. In some cases, people with fever may develop low blood pressure and dizziness.
Tell your doctor, nurse or pharmacist immediately if you get a temperature above 38.5°C while you are taking your medicine.
They will carry out tests to find out if there are other causes for the fever and treat the problem with other medicines.
If you are taking Mekinist or Mekinist and dabrafenib together you may be asked to interrupt treatment if your temperature is above 40°C. If your fever is controlled your doctor may recommend that you resume both treatments at a lower dose, or that you receive only Mekinist treatment.
If you are taking Mekinist or Mekinist and dabrafenib together you may be asked to interrupt dabrafenib treatment if your temperature is between 38.5°C and 40°C inclusive. Your Mekinist treatment may continue. If your fever is controlled your doctor may recommend that you resume dabrafenib treatments either at the same dose or a lower dose.
If the fever is very severe or keeps returning, your doctor may recommend that you stop taking dabrafenib and only receive treatment with Mekinist.
Heart disorder
Mekinist can cause heart problems, or make existing heart problems worse (see also 'Heart conditions' in Side Effects)
Tell your doctor if you have a heart disorder.
Your doctor will run tests to check that your heart is working properly before and during your treatment with your medicine.
Tell your doctor immediately if you feel:
like your heart is pounding, racing, or beating irregularly;
dizziness, tiredness, lightheaded, shortness of breath or swelling in the legs.
If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether. If you are taking the combination treatment you may be allowed to continue treatment as normal with dabrafenib.
Eye problems
Mekinist can cause eye problems including blindness.
Tell your doctor immediately if you get these following symptoms of eye problems during your treatment:
blurred vision
loss of vision or other vision changes
see colour dots, halos (seeing blurred outline around objects).
If you develop any of these symptoms, your doctor or nurse will arrange for a full eye examination. If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether. If you are taking the combination treatment you may be allowed to continue treatment as normal with dabrafenib.
Skin problems
Severe skin reactions (rash) can happen while taking Mekinist (see also 'Rash or other skin problems' in Side Effects).
Talk to your doctor if you get a skin rash.
Depending on how bad your rash is, you may be asked to interrupt treatment, or take your treatment at a lower dose because of the rash.
Talk to your doctor immediately if you get a severe skin rash with any of the following symptoms:
blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever,
redness or swelling of your face, hands, or soles of your feet.
Lung disease
Mekinist can cause lung problems, including interstitial lung disease and pneumonitis
Tell your doctor immediately if you get any of these following symptoms of lung problems: -
shortness of breath
difficulty breathing
These may lead to low oxygen in your blood resulting in light headedness, fatigue and confusion.
You may have your breathing checked by your doctor while you are taking Mekinist to check for any lung disease.
If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether
Bleeding problems
Mekinist, when taken in combination with dabrafenib, can cause serious bleeding problems,
Call your doctor or nurse and get medical help immediately if you have any unusual signs of bleeding, including:
headaches, dizziness, or feeling weak
coughing up blood or blood clots
vomiting blood or if your vomit looks like "coffee grounds"
red or black stools that look like tar
Read the information in Side Effects - Signs you need to look out for.

Things you must not do

Do not take Mekinist 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 stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Mekinist affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Mekinist.
Like all medicines, Mekinist 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 Serious Side Effects

Fever (high temperature)
Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although it is most likely if you are taking the combination treatment.
Signs and symptoms of fever include:
high temperature (temperature of 38.5°C or above)
shivering
dehydration (you may feel very thirsty)
low blood pressure (you may feel dizzy, faint, or as if you are going to be sick)
Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.
Heart conditions
Mekinist can affect how well your heart pumps with each beat. People may be more likely to develop this side effect if they have an existing heart problem. You will be checked for any heart problems while you are taking Mekinist. Signs and symptoms of heart problems include:
feeling like your heart is pounding, racing, or beating irregularly
dizziness
tiredness
feeling lightheaded
shortness of breath
swelling in the legs
Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.
Eye (vision) problems
Mekinist can cause eye problems. Mekinist is not recommended if you have ever had a blockage of the vein draining the eye (retinal vein occlusion). Your doctor may advise an eye examination while you are taking Mekinist. Your doctor may ask you to stop taking Mekinist or refer you to a specialist, if you develop signs and symptoms in your vision that include:
loss of vision
eye redness and irritation
colour dots
halo (seeing a blurred outline around objects)
blurred vision
Rash or other skin problems
Mekinist can cause rash or acne-like rash. Follow your doctor's instructions for what to do to help prevent rash.
Tell your doctor or nurse as soon as possible, if you get any of these symptoms for the first time or if they get worse.
Contact your doctor immediately if you get a severe skin rash with any of the following symptoms:
blisters on your skin,
blisters or sores in your mouth,
peeling of your skin,
fever,
redness or swelling of your face, or soles of your feet.
Tell your doctor or nurse as soon as possible if you get any skin rash, or if you have a rash that gets worse.
Lung disease
Mekinist can cause lung problems, including interstitial lung disease and pneumonitis
Tell your doctor immediately if you get any of these following symptoms of lung problems:
shortness of breath and difficulty breathing which may lead to low oxygen in your blood which can result in light headedness, fatigue and confusion.
BLEEDING problems
Mekinist, when taken in combination with dabrafenib, can cause serious bleeding problems, especially in your brain or stomach, and can lead to death.
Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:
headaches, dizziness, or feeling weak
cough up blood or blood clots
vomit blood or your vomit looks like "coffee grounds"
red or black stools that look like tar

Possible side effects when taking Mekinist 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.
skin rash, acne-like rash , redness of the face, dry or itching skin
diarrhoea
feeling sick (nausea), being sick (vomiting)
constipation
stomach ache
dry mouth
lack of energy or feeling weak or tired
swelling of the hands or feet
unusual hair loss or thinning
high blood pressure
bleeding, at various sites in the body, which may be mild or serious
fever (high temperature)
cough
shortness of breath

Common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 10 people.
inflammation of hair follicles in the skin
skin rash with pus-filled blisters
redness, chapping or cracking of the skin
infection of the skin (cellulitis)
nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
red, painful hands and feet
nose bleeds
sore mouth or mouth ulcers, inflammation of mucous membranes
inflammation of the lung (pneumonitis or interstitial lung disease), swelling of the face, localised tissue swelling
blurred vision
swelling around the eyes
eyesight problems
feeling weak
changes in how the heart pumps blood (left ventricular dysfunction)
abnormal blood test results related to the liver
decreased red blood cells (anaemia)
abnormal test results related to creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
dehydration (low levels of water or fluid)
allergic reaction (hypersensitivity)

Uncommon side effects

Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 100 people.
blockage of the vein draining the eye (retinal vein occlusion)
swelling in the eye caused by fluid leakage (chorioretinopathy)
breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)
swelling of nerves at the back of the eye (papilloedema)
separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment).
heart pumping less efficiently, causing shortness of breath, extreme tiredness and swelling in ankles and legs (heart failure)

Possible side effects when taking Mekinist together with dabrafenib

Refer to the Patient Information leaflet for dabrafenib for possible side effects and important signs and symptoms to look out for, such as fever, skin problems and eye problems.
When you take Mekinist and dabrafenib 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.
urinary tract infection
headache
decreased appetite
chills
dizziness
night sweats
Joint pain, muscle pain, or pain in the hands or feet
muscle spasms

Very common side effects that may show up in your blood tests

low levels of white blood cells

Common side effects

Tell your doctor or pharmacist if you notice any of the following that may affect up to 1 in 10 people.
low blood pressure
skin effects including rough scaly patches of skin, brown or yellowish thickening of the skin, skin tags
thickening of the outer layers of the skin
skin effects such as rash, wart-like growths
inflammation of the pancreas (causing strong abdominal pain)
inflammation of the eye (Uveitis)
flu-like illness
excessive sweating
bleeding, at various sites in the body, which may be mild or serious
breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)

Common side effects that may show up in your blood tests

decrease in number of blood platelets (cells that help blood to clot)
low levels of sodium in the blood
increase in some substances (enzymes) produced by the liver
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

After using Mekinist

Storage

Keep Mekinist in the refrigerator between 2°C and 8°C. Do not freeze.
Keep it where children cannot reach it.
Keep your tablets in the bottle until it is time to take them.
Do not remove the desiccant.
The bottle may be stored out of the refrigerator for a maximum of 30 days.
Do not store Mekinist or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car.

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 Mekinist tablets look like

Mekinist tablets are available in plastic bottles containing 30 tablets. The bottle has a child resistant closure and also contains a desiccant.
0.5 mg tablets
Yellow, modified oval, biconvex, film-coated tablets with 'GS' debossed on one face and 'TFC' on the opposite face.
2 mg tablets
Pink, round, biconvex, film-coated tablets with 'GS' debossed on one face and 'HMJ' on the opposite face.

Ingredients

Each Mekinist tablet contains trametinib dimethyl sulfoxide, equivalent to 0.5 mg or 2 mg per tablet as the active ingredient.
The tablets also contain the following ingredients:
mannitol (E421)
cellulose - microcrystalline (E460(i))
hypromellose (E464)
croscarmellose sodium
magnesium stearate (E572)
sodium lauryl sulphate
silica - colloidal anhydrous
0.5 mg tablet only
The 0.5 mg tablet also contains:
Opadry 03B120006 Yellow
2 mg tablet only
The 2 mg tablet also contains:
Opadry YS-1-14762-A Pink
Mekinist does not contain lactose, sucrose, gluten, tartrazine, or any other azo dyes.

Sponsor

Mekinist is supplied in Australia 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:
AUST R 205917: Mekinist trametinib 0.5 mg (as dimethyl sulfoxide) tablet
AUST R 205919: Mekinist trametinib 2 mg (as dimethyl sulfoxide) tablet
This leaflet was prepared in
July 2015.
For internal use only
(mek100715c based on
mek100715i)