Osimertinib mesilate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions people ask about TAGRISSO. 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 will have weighed the risks of you taking TAGRISSO 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.
What TAGRISSO is used for
This medicine is used to treat adults with a type of cancer called 'non-small cell lung cancer' when the tumour has a defect (mutation) in a gene called EGFR (epidermal growth factor receptor).
TAGRISSO can be prescribed for you if you test positive for EGFR mutation.
This medicine belongs to a class of medicines called Tyrosine Kinase Inhibitors (TKIs). It works by stopping cancer cells with the EGFR mutation from growing and multiplying.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
It is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or operate machinery, however, if symptoms occur that affect your ability to concentrate, do not drive or operate machinery until the effect subsides.
Before you use TAGRISSO
When you must not take it
Do not take TAGRISSO if you have an allergy to:
any of the ingredients listed at the end of this leaflet
any other similar medicines for example other TKIs.
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 if you are pregnant or if you (male or female) are planning to have a baby.
It may affect your developing baby if you take it during pregnancy.
Your doctor will advise men and women to ensure they are using effective contraception when using the medicine and for at least 6 weeks for woman and 4 months for men after stopping the medicine.
Do not breast-feed if you are taking this medicine.
It is not known if the active ingredient in TAGRISSO passes into breast milk. If it does, your baby may be affected.
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 if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
inflamed lungs (called 'interstitial lung disease'), pneumonia or other lung problems
heart problems or risk factors for heart problems. Your doctor may wish to monitor your heart before and during TAGRISSO treatment.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
If you are a man, tell your doctor if you are planning to have a baby with your partner.
Your doctor can discuss with you the risks and benefits involved. Whether you are male or female, your doctor will advise you to use an effective form of contraception while taking TAGRISSO and for at least 6 weeks for woman and 4 months for men after stopping treatment.
Tell your doctor if you use or want to use contact lenses while you are taking TAGRISSO.
If you have not told your doctor about any of the above, tell them before you start taking TAGRISSO.
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.
These include:
antibiotics such as rifampicin for treating bacterial infections
medicines for epilepsy such as phenytoin and carbamazepine
St John's Wort for treating depression
rosuvastatin, a medicine used to treat high cholesterol levels
oral hormone contraceptive pill to prevent pregnancy
warfarin, a medicine used to prevent blood clots
bosentan, a medicine used to treat high blood pressure in the lungs
efavirenz and etravirine, medicines used to treat HIV infections
any medicine being used to treat your cancer.
These medicines may not work properly if you are taking TAGRISSO or they may affect how well TAGRISSO 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.
How to take TAGRISSO
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, ask your doctor or pharmacist for help.
How much to take
The usual dose is one 80 mg tablet per day. Your doctor may however prescribe a different dose such as one 40 mg tablet.
How to take it
Swallow the tablets whole with a full glass of water. If you can swallow the tablet whole, do not split, crush or chew it.
If you cannot swallow the tablet, it can be dispersed by stirring in about one quarter of a cup of water and then immediately swallowed (it will not completely dissolve). Once finished, swirl the same amount of water in the cup and swallow it to ensure that none of the dispersed tablet is missed.
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.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
It is important to keep taking your medicine even if you feel well.
If you forget to take it
If it is less than 12 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
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 take too much (overdose)
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 TAGRISSO. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using TAGRISSO
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking TAGRISSO.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Ensure you are using effective contraception. Even if you stop treatment, you should continue to use effective contraception for at least a further 6 weeks if you are a woman and a further 4 months if you are a man.
If you become pregnant while you are taking this medicine or within 6 weeks of stopping this medicine, tell your doctor immediately.
If you are a man and your partner becomes pregnant while you are taking this medicine or within 4 months of stopping this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
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. For example, periodic tests may be done if you have had heart problems in the past.
Things you must not do
Do not take TAGRISSO 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 even if you feel well. Do not lower the dosage without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how TAGRISSO affects you.
Side effects
Tell your doctor or pharmacist as soon as possible if you start feeling worse while you are taking TAGRISSO.
This medicine helps the majority of people with your type of cancer, but it may have unwanted side effects. All medicines can have side effects. 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.
Tell your doctor immediately if you notice any of the following:
sudden difficulty in breathing with a cough or fever. This may be a sign of inflamed lungs called 'interstitial lung disease'. Most cases can be treated but some cases have been fatal . Your doctor may wish to stop treatment if you get this side effect.
sore or inflamed (red or puffy) eyes, teary eyes, light sensitivity, blurred vision.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
diarrhoea. This may come and go during treatment. Tell your doctor if your diarrhoea does not go away or becomes severe
skin and nail problems. Signs may include itching, dry skin, rash, redness around the fingernails. This is more likely in areas exposed to the sun. Using moisturisers regularly on your skin and nails can help with this. Tell your doctor if your skin or nail problems get worse
increased susceptibility to infection and/or symptoms of fever as this can be associated with a reduction in the number of white blood cells (leukocytes, lymphocytes or neutrophils).
inflammation of the inner lining of the mouth
bruising easily, blood when you go to the toilet, bleeding from a cut longer than normal, nose or gum bleeding, yellowing of skin and/or eyes. This could mean your platelet count (number of cells in your blood that naturally cause it to clot) is too low and you may need blood tests.
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
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 TAGRISSO
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store TAGRISSO or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
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 it looks like
There are 2 tablet strengths:
The 40 mg strength tablets are round, beige, coated tablets approximately 9 mm wide. The tablets have 'AZ' and '40' on one side.
The 80 mg strength tablets are oval, beige, coated tablets measuring approximately 7.25 × 14.5 mm. The tablets have 'AZ 80' on one side.
The tablets are packed into aluminium blister strips in cartons of 30 tablets.
Ingredients
TAGRISSO contains 40 mg or 80 mg of osimertinib (as osimertinib mesilate) as the active ingredient.
Other ingredients include:
Mannitol
microcrystalline cellulose
polyvinyl alcohol
hyprolose
sodium stearyl fumarate
titanium dioxide
talc
iron oxide black
iron oxide red
iron oxide yellow
macrogol 3350.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
