Mekinist Tablets

Mekinist Tablets is a brand of medicine containing the active ingredient trametinib.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

MEKINIST®

trametinib (as dimethyl sulfoxide) 0.5, 1 and 2 mg Tablets


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start using MEKINIST.

This leaflet answers some common questions about MEKINIST. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MEKINIST against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

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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. This medicine contains the active ingredient 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.

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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

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. 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.

Tell your doctor or nurse if you have or have had any of the following medical conditions:

  • if you have any heart problems such as heart failure or problems with the way your heart beats.
  • if you have 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).
  • if you have 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 disease (pneumonitis).
  • if you have 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; symptoms include:
    - eye redness and irritation
    - blurred vision
    - eye pain
    - increased sensitivity to light
    - floating spots before the eyes

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.

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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 box or 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 any more MEKINIST than your doctor has recommended.

How to take it

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

When to take it

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.

Take MEKINIST once a day on an empty stomach so:

  • after taking MEKINIST, wait at least 1 hour before eating
    or
  • after eating , wait at least 2 hours before taking MEKINIST.

Taking MEKINIST together with dabrafenib

Swallow the MEKINIST tablet and the dabrafenib capsule, with a full glass of water

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 the same time each day with either the morning dose or the evening dose of dabrafenib. 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 and do not take 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.

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 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 and just 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.

In New Zealand, immediately telephone your doctor or the National Poisons Centre (telephone 0800 POISON or 0800 764 766), 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.

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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 also 'Fever' in Side Effects), although it 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: -
    - blurred vision, loss of vision or other vision changes, see colour dots, halos (seeing blurred outline around objects) during your treatment.
    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 and difficulty breathing which 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 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

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.

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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 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.

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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.

Store in the original container.

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.

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Product description

What it looks like

  • The MEKINIST 0.5 mg tablets are yellow, modified oval, biconvex, film-coated tablets with 'GS' debossed on one face and 'TFC' on the opposing face. This product is packaged with a desiccant.
  • The MEKINIST 1 mg tablets are white, round, biconvex, film-coated tablets with 'GS' debossed on one face and 'LHE' on the opposing face. This product is packaged with a desiccant.
  • The MEKINIST 2 mg tablets are pink, round, biconvex, film-coated tablets with 'GS' debossed on one face and 'HMJ' on the opposing face. This product is packaged with a desiccant.

Ingredients

Each tablet contains trametinib dimethyl sulfoxide equivalent to 0.5, 1 or 2 mg of trametinib as the active ingredient.

Each tablet also contains the following excipients:

  • mannitol,
  • cellulose - microcrystalline,
  • hypromellose,
  • croscarmellose sodium,
  • magnesium stearate,
  • sodium lauryl sulphate
  • silica - colloidal anhydrous
  • Opadry 03B120006 Yellow (0.5 mg tablet only),
  • Opadry OY-S-28876 White (1 mg tablet only)
  • Opadry YS-1-14762-A Pink (2 mg tablet only).

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

MEKINIST is supplied in Australia by:
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia.

MEKINIST is supplied in New Zealand by:
GlaxoSmithKline NZ Ltd
Private Bag 106600
Downtown
Auckland 1143
New Zealand

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from patient information groups and books, for example in public libraries.

This leaflet was prepared on 6 February 2014.

  • MEKINIST 0.5 mg: AUST R 205917
  • MEKINIST 1 mg: AUST R 205918
  • MEKINIST 2 mg: AUST R 205919

MEKINIST® = Registered Trademark of the GlaxoSmithKline group of companies

This leaflet is subject to copyright.

Version 1.0

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CMI provided by MIMS Australia, October 2015  

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