Patient leaflet - Tagrisso
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
his 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. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What TAGRISSO is and what it is used for
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2. What you need to know before you take TAGRISSO
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3. How to take TAGRISSO
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4. Possible side effects
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5. How to store TAGRISSO
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6. Contents of the pack and other information
1. What TAGRISSO is and what it is used for
TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer. TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.’ If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR’ (epidermal growth factor receptor) your cancer is likely to respond to treatment with TAGRISSO. TAGRISSO can be prescribed for you:
- after complete removal of your cancer as a post-surgical (adjuvant) treatment or
- as the first medicine you receive for your cancer which has spread to other parts of the body or
- in certain circumstances if you have been treated for your cancer before with other protein kinase inhibitor medicines.
How TAGRISSO works
TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour and prevent the tumour from coming back after removal by surgery.
- If you are receiving TAGRISSO after complete removal of your cancer, it means that your cancer contained defects in the EGFR gene, ‘exon 19 deletion’ or ‘exon 21 substitution mutation’.
If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletion’ or ‘exon 21 substitution mutation’.
- If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M’. Because of this defect, other protein kinase medicines may no longer work.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take TAGRISSO
Do not take TAGRISSO if:
- you are allergic (hypersensitive) to osimertinib or any of the other ingredients of this medicine (listed in section 6).
- you are taking St. John’s Wort (Hypericum perforatum).
If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
- you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease’).
- you have ever had heart problems – your doctor may want to keep a close eye on you.
- you have a history of eye problems.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Tell your doctor straight away while taking this medicine if:
- you have sudden difficulty in breathing together with a cough or fever.
- you have severe peeling of your skin.
- you have rapid or irregular heartbeats, dizziness, light-headedness, chest discomfort, shortness of
breath and fainting.
- you have watery eyes, sensitivity to light, eye pain, eye redness or vision changes.
See ‘Serious side effects’ in section 4 for more information.
Children and adolescents
TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years.
Other medicines and TAGRISSO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. This is because TAGRISSO can affect the way some other medicines work. Also some other medicines can affect the way TAGRISSO works.
Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
The following medicines may reduce how well TAGRISSO works:
- Phenytoin, carbamazepine or phenobarbital – used for seizures or fits.
- Rifabutin or rifampicin – used for tuberculosis (TB).
- St. John’s Wort (Hypericum perforatum) – an herbal medicine used for depression.
TAGRISSO may affect how well the following medicines work and/or increase side effects of these medicines:
- Rosuvastatin – used to lower cholesterol.
- Oral hormonal contraceptive pill- used to prevent pregnancy.
- Bosentan – used for high blood pressure in the lungs.
- Efavirenz and etravirine – used to treat HIV infections/AIDS.
- Modafinil – used for sleep disorders.
- Dabigatran – used to prevent blood clots.
- Digoxin – used for irregular heart beat or other heart problems.
- Aliskiren – used for high blood pressure.
If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO.
Your doctor will discuss appropriate treatment options with you.
Pregnancy – information for women
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant during treatment, tell your doctor straight away. Your doctor will decide with you whether you should carry on taking TAGRISSO.
- You should not become pregnant while taking this medicine. If you are able to become pregnant, you must use effective contraception. See ‘Contraception – information for women and men’ below.
- If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice. This is because some medicine may remain in your body, (see advice on contraception below).
Pregnancy – information for men
- If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.
Contraception – information for women and men
You must use effective contraception during treatment.
- TAGRISSO may interfere with how well oral hormonal contraceptives work. Discuss with your doctor the most appropriate methods of contraception.
- TAGRISSO may pass into semen. Therefore, it is important that men also use effective
contraception.
You must also do this after completing treatment with TAGRISSO:
- Women – keep using contraception for 2 months after.
- Men – keep using contraception for 4 months after.
Breast-feeding
Do not breast-feed while taking this medicine. This is because it is not known if there is a risk to your baby.
Driving and using machines
TAGRISSO has no or no marked influence on the ability to drive and use machines.
Information on other ingredients in this medicine
This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
3. How to take TAGRISSO
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
- The recommended dose is one 80 mg tablet each day.
- If necessary, your doctor may reduce your dose to one 40 mg tablet each day.
How to take
- TAGRISSO is taken by mouth. Swallow the tablet whole with water. Do not crush, split or chew
the tablet.
- Take TAGRISSO every day at the same time.
- You can take this medicine with or without food.
If you have trouble swallowing the tablet, you can mix it in water:
- Put the tablet in a glass.
- Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water – do not use any other liquids.
- Stir the water until the tablet breaks up into very small pieces – the tablet will not completely dissolve.
- Drink the liquid straight away.
- To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.
If you take more TAGRISSO than you should
If you take more than your normal dose, contact your doctor or nearest hospital straight away.
If you forget to take TAGRISSO
If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time.
If you stop taking TAGRISSO
Do not stop taking this medicine – talk to your doctor first. It is important to take this medicine every day, for as long as your doctor prescribes it for you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor straight away if you notice the following serious side effects (see also section 2):
- Sudden difficulty in breathing together with a cough or fever – this may be a sign of inflamed lungs (a condition called ‘interstitial lung disease’). Most cases can be treated but some cases have been fatal. Your doctor may wish to stop TAGRISSO if you get this side effect. This side effect is common: it may affect up to 1 in 10 people.
- Stevens-Johnson syndrome, which can appear as reddish target-like macules or circular patches
often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms. This side effect is rare: it may affect up to 1 in 1000 people.
- Changes in the electrical activity in the heart (QTc prolongation) such as rapid or irregular heartbeats, dizziness, light-headedness, chest discomfort, shortness of breath and fainting. This side effect is uncommon: it may affect up to 1 in 100 people.
- If you develop watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. This side effect is uncommon: it may affect up to 1 in 100 people.
Tell your doctor straight away if you notice the serious side effects listed above.
Other side effects
Very common (may affect more than 1 in 10 people)
- 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 pain, 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.
- Stomatitis – inflammation of the inner lining of the mouth or ulcers forming in the mouth.
- Loss of appetite.
- Reduction in the number of white blood cells (leukocytes, lymphocytes or neutrophils).
- Reduction in the number of platelets in the blood.
Common (may affect up to 1 in 10 people)
- Nose bleed (epistaxis).
- Hair thinning (alopecia).
- Hives (urticaria) – itchy, raised patches anywhere on the skin, which may be pink or red and round in shape. Tell your doctor if you notice this side effect.
- Hand-foot syndrome – this may include redness, swelling, tingling or burning sensation with
cracking of the skin on the palms of hands and/or soles of feet.
- Increase of a substance in the blood called creatinine (produced by your body and removed by the kidney).
Uncommon (may affect up to 1 in 100 people)
- Target lesions, which are skin reactions that look like rings (suggestive of Erythema multiforme).
- Inflammation of the blood vessels in the skin. This may give the appearance of bruising or redness of the skin that does not fade in colour when pressed (non-blanching).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store TAGRISSO
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date (EXP) which is stated on the blister foil and carton. The expiry date refers to the last day of that month.
- This medicine does not require any special storage conditions.
- Do not use any pack that is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What TAGRISSO contains
- The active substance is osimertinib (as mesylate). Each 40 mg film-coated tablet contains 40 mg of osimertinib. Each 80 mg film-coated tablet contains 80 mg of osimertinib.
- The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide (see section 2 “Information on other ingredients in this medicine”).
What TAGRISSO looks like and contents of the pack
TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
TAGRISSO is supplied in blisters containing 30 × 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
TAGRISSO is supplied in blisters containing 28 × 1 film-coated tablets, packed in cartons containing
4 blisters of 7 tablets each.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
| Belgie/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Efc^rapufl Acmpa3eHeKa Etarapua EOOfl Tea.: +359 24455000 | Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tel/Tel: +32 2 370 48 11 |
| Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | Magyarorszag AstraZeneca Kft. Tel.: +36 1 883 6500 |
| Danmark AstraZeneca A/S Tlf: +45 43 66 64 62 | Malta Associated Drug Co. Ltd Tel: +356 2277 8000 |
| Deutschland AstraZeneca GmbH | Nederland AstraZeneca BV |
| Tel: +49 41 03 7080 | Tel: +31 79 363 2222 |
| Eesti AstraZeneca Tel: +372 6549 600 | Norge AstraZeneca AS Tlf: +47 21 00 64 00 |
| EXXáSa AstraZeneca A.E. Tql: +30 210 6871500 | Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
| España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 | Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00 |
| France AstraZeneca Tél: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00 |
| Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000 | Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
| Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 | Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 |
| Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777 |
| Italia AstraZeneca S.p.A. Tel: +39 02 9801 1 | Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
| Kúnpog AXéKTop Oap^aKeuTiK^ At5 Tql: +357 22490305 | Sverige AstraZeneca AB Tel: +46 8 553 26 000 |
| Latvija SIA AstraZeneca Latvija Tel: +371 67377100 | United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836 |
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
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Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease >6 weeks
CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
A HR <1 favours TAGRISSO