Tagrisso 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tagrisso 40 mg film-coated tablets

Tagrisso 80 mg film-coated tablets

osimertinib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What TAGRISSO is and what it is used for
2. What you need to know before taking TAGRISSO
3. How to take TAGRISSO
4. Possible side effects
5. How to store TAGRISSO
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 kinase inhibitors, used to treat cancer. TAGRISSO is used to treat adults with a type of lung cancer known as "non-small cell lung cancer". Your cancer is likely to respond to treatment with TAGRISSO if a test has shown that your cancer has certain changes (mutations) in a gene called “EGFR” (epidermal growth factor receptor).

TAGRISSO as monotherapy may be prescribed to you:

• after complete removal of your cancer as adjuvant (post-surgical) treatment

or

• for cancer that cannot be removed (resected) by surgery and that has responded to or stabilized after treatment with chemotherapy and radiation

or

• as the first medicine you receive for your cancer that has spread to other parts of the body

or

• under certain circumstances, if you have previously been treated for your cancer with other kinase inhibitor medicines.

TAGRISSO may be prescribed to you in combination with other anticancer medicines, such as:

• pemetrexed and a platinum-containing chemotherapy, as the first medicine you receive for your cancer that has spread to other parts of the body

When TAGRISSO is given in combination with other anticancer medicines, it is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, consult your doctor.

How TAGRISSO works

TAGRISSO works by blocking EGFR and may help stop your lung cancer from growing or slow its growth. It may also help reduce tumor size and prevent the tumor from returning after surgical removal.

• If you are receiving TAGRISSO after complete removal of your cancer, it means your cancer had defects in the EGFR gene, “exon 19 deletion” or “exon 21 substitution mutation”.

• If you are receiving TAGRISSO for cancer that cannot be removed (resected) by surgery and that has responded to or stabilized after treatment with chemotherapy and radiotherapy, it means your cancer has defects in the EGFR gene, “exon 19 deletion” or “exon 21 substitution mutation”.

• If TAGRISSO is the first kinase inhibitor medicine you are taking, it means your cancer has defects in the EGFR gene called “exon 19 deletion” or “exon 21 substitution mutation”.

• If your cancer has progressed while being treated with another kinase inhibitor medicine, it means your cancer has a defective gene called “T790M”. Due to this defect, other kinase inhibitor medicines may no longer work.

If you have any questions about how this medicine works, or why it has been prescribed for you, consult your doctor.

2. What you need to know before starting TAGRISSO

Do not take TAGRISSO if:

• you are allergic (hypersensitive) to osimertinib or to any of the other ingredients of this medicine (listed in section 6).
• you are taking St. John’s wort (Hypericum perforatum).

If you are unsure, consult your doctor, pharmacist, or nurse before taking TAGRISSO.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting TAGRISSO if:

• you have previously had lung inflammation (a condition called "interstitial lung disease").
• you have ever had heart problems – your doctor may want to monitor you closely.
• you have a history of eye problems.
• you have ever had or may have a hepatitis B virus infection. This is important because TAGRISSO could cause reactivation of the hepatitis B virus. Inform your doctor or nurse if you develop increasing tiredness or notice yellowing of the skin or whites of the eyes.

If any of the above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before taking this medicine.

Contact your doctor immediately while taking this medicine if:

• you experience sudden difficulty breathing along with cough or fever.
• you develop severe skin peeling.
• you have rapid or irregular heartbeat, dizziness, lightheadedness, chest discomfort, shortness of breath, or fainting.
• you develop watery eyes, light sensitivity, eye pain, red eyes, or changes in vision. For more information, see "Serious adverse reactions" in section 4.
• you develop persistent fever, bruising or bleeding more easily, increased tiredness, pale skin, or infection. For more information, see "Serious adverse reactions" in section 4.

Children and adolescents

TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.

Taking TAGRISSO with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines and herbal remedies. This is because TAGRISSO may affect how other medicines work, and other medicines may also affect TAGRISSO.

Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:

The following medicines may reduce the effectiveness of TAGRISSO:

• Phenytoin, carbamazepine, or phenobarbital – used to treat epileptic seizures or convulsions.
• Rifabutin or rifampicin – used to treat tuberculosis (TB).
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.

TAGRISSO may affect the effectiveness of the following medicines and/or increase their adverse effects:

• 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/AIDS infections.
• Modafinil – used for sleep disorders.
• Dabigatran – used to prevent blood clots.
• Digoxin – used for irregular heartbeat or other heart problems.
• Aliskiren – used for high blood pressure.

If you are taking any of the medicines listed above, inform your doctor before taking TAGRISSO. Your doctor will discuss with you the appropriate treatment options.

Pregnancy – information for women

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine. If you become pregnant during treatment, contact your doctor immediately. Your doctor will decide with you whether you should continue taking TAGRISSO.
• You must not become pregnant while taking this medicine. If you can become pregnant, you must use effective contraception. See section "Contraception – information for women and men" below.
• Consult your doctor if you plan to become pregnant after taking the last dose of this medicine. This is because some of the medicine may remain in your body (see advice under contraception below).

Pregnancy – information for men

• If your partner becomes pregnant while you are taking this medicine, inform your doctor immediately.

Contraception – information for women and men

You must use effective contraceptive methods during treatment.

• TAGRISSO may interfere with the effectiveness of oral hormonal contraceptives. Discuss the most suitable contraceptive methods with your doctor.
• TAGRISSO may pass into human semen. Therefore, it is important that men also use an effective method of contraception.

You should also continue the following after stopping treatment with TAGRISSO:

• Women – continue using contraceptive methods for 2 months after.
• Men – continue using contraceptive methods for 4 months after.

Breast-feeding

Do not breast-feed while taking this medicine, as it is unknown whether there is a risk to your baby.

Driving and using machines

TAGRISSO has no effect or negligible effect on the ability to drive and use machines.

TAGRISSO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take TAGRISSO

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose to take

• The recommended dose is one 80 mg tablet daily when TAGRISSO is administered as monotherapy.
• The recommended dose of TAGRISSO is one 80 mg tablet daily when administered with pemetrexed and platinum-containing chemotherapy.
• If necessary, your doctor may reduce your dose to one 40 mg tablet daily.

How to take it

• TAGRISSO is taken orally. Swallow the tablet whole with water. Do not crush, split, or chew the tablet.
• Take TAGRISSO every day at the same time.
• You may take this medicine with or without food.

If you have difficulty swallowing the tablet, you may mix it in water:

• Place the tablet in a glass.
• Add 50 ml (about two-thirds of a glass) of non-carbonated water – do not use any other liquid.
• Stir the water until the tablet breaks into very small pieces – the tablet will not dissolve completely.
• Drink the liquid immediately.
• To ensure you have taken all 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 prescribed dose, contact your doctor or go to the nearest hospital immediately.

If you forget to take TAGRISSO

If you forget to take a dose, take it as soon as you remember. However, if less than 12 hours remain before your next dose, do not take the missed dose. Take the next dose at the usual time.

If you stop taking TAGRISSO

Do not stop taking this medicine – consult your doctor first. It is important that you take this medicine every day for the duration prescribed by your doctor.

If you have any further questions about 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 everyone will experience them.

Serious side effects

Contact your doctor immediately if you experience the following serious side effect (see also section 2):

• Sudden difficulty breathing accompanied by cough or fever – this may be a sign of lung inflammation (a condition called "interstitial lung disease"). Most cases can be treated, but some have been fatal. Your doctor may want to discontinue treatment with TAGRISSO if you experience this side effect. This is a common side effect: it may affect up to 1 in 10 people.
• Stevens-Johnson syndrome and toxic epidermal necrolysis, which may appear as red, target-like spots or circular patches, often with central blisters on the trunk, skin peeling, mouth ulcers, and sores in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. Stevens-Johnson syndrome is rare: it may affect up to 1 in 1,000 people. The frequency of toxic epidermal necrolysis cannot be determined as only individual cases have been reported since TAGRISSO has been marketed.
• Changes in the electrical activity of the heart (QTc prolongation), such as rapid or irregular heartbeat, dizziness, lightheadedness, chest discomfort, shortness of breath, and fainting. This side effect is common: it may affect up to 1 in 10 people.
• If you notice watery eyes, light sensitivity, eye pain, eye redness, or changes in vision. This effect is uncommon: it may affect up to 1 in 100 people.
• A blood disorder called aplastic anemia, in which the bone marrow stops producing new blood cells – signs suggesting this disorder may include persistent fever, easy bruising or bleeding, increased fatigue, and reduced ability to fight infections. This adverse effect is rare: it may affect up to 1 in 1,000 people.
• A condition in which the heart, when beating, does not pump enough blood out of the heart as effectively as it should, which could lead to difficulty breathing, fatigue, and swelling of the ankles (suggestive of heart failure or reduced left ventricular ejection fraction).

Contact your doctor immediately if you notice any of the above serious side effects.

Other side effects

Very common (may affect more than 1 in 10 people)

• Diarrhea – may occur intermittently during treatment. Inform your doctor if diarrhea does not resolve or worsens.
• Itching of the skin (pruritus) – regular application of moisturizing creams on your skin may help improve this.
• Skin and nail problems – including pain, itching, dry skin, skin rash, and redness around the fingernails. These are more likely to occur in sun-exposed areas. Regular application of moisturizing creams on your skin and nails may help improve this. Inform your doctor if your skin or nail problems worsen.
• Stomatitis: inflammation of the inner lining of the mouth or development of mouth ulcers.
• Loss of appetite.

Common (may affect up to 1 in 10 people):

• Lung inflammation caused by chest radiotherapy (radiation pneumonitis).
• Nosebleeds (epistaxis).
• Hair thinning (alopecia).
• Hives (urticaria) – raised, itchy spots anywhere on the skin, which may be pink or red and round-shaped. Inform your doctor if you notice this side effect.
• Hand-foot syndrome – may include redness, swelling, tingling or burning sensation with skin cracking on the palms of the hands and/or soles of the feet.
• Increase in a substance in the blood called creatinine (produced by your body and eliminated by the kidneys).
• Increase in a substance in the blood called creatine phosphokinase (an enzyme released into the blood when muscle is damaged).
• Decrease in the number of white blood cells in the blood (leukocytes, lymphocytes, or neutrophils).
• Decrease in the number of platelets in the blood.

Uncommon (may affect up to 1 in 100 people)

• Target lesions, which are ring-shaped skin reactions (suggestive of erythema multiforme).
• Inflammation of blood vessels in the skin. This may appear as bruises or redness of the skin that does not fade when pressed (non-blanching).
• Inflammation of muscle that may cause muscle pain or weakness.
• Grayish or darkened skin (hyperpigmentation).

Frequency not known (cannot be estimated from available data)

• Reactivation of hepatitis B virus.

The following adverse effects have been reported in a clinical trial with patients who received TAGRISSO in combination with pemetrexed and platinum-containing chemotherapy:

Very common (may affect more than 1 in 10 people)

• Diarrhea – may occur and resolve intermittently during treatment. Inform your doctor if diarrhea does not resolve or worsens.
• Skin and nail problems – including pain, itching, dry skin, rash, and redness around the fingernails. These are more likely in sun-exposed areas. Regular application of moisturizing creams on your skin and nails may help improve this. Inform your doctor if your skin or nail problems worsen.
• Stomatitis – inflammation of the inner lining of the mouth or development of mouth ulcers.
• Loss of appetite.
• Reduction in the number of white blood cells (leukocytes, lymphocytes, or neutrophils).
• Reduction in the number of platelets in the blood.
• Increase in a substance in the blood called creatinine (produced by the body and eliminated by the kidneys).

Common (may affect up to 1 in 10 people)

• Nosebleeds (epistaxis).
• Itching of the skin (pruritus) – regular application of moisturizing creams on your skin may help improve this.
• Hair thinning (alopecia).
• Target lesions, which are ring-shaped skin reactions (suggestive of erythema multiforme).
• Hives (urticaria) – raised, itchy spots anywhere on the skin, which may be pink or red and round-shaped. Inform your doctor if you notice this side effect.
• Grayish or darkened skin (hyperpigmentation).
• Hand-foot syndrome – may include redness, swelling, tingling or burning sensation with skin cracking on the palms of the hands and/or soles of the feet.
• Increase in a substance in the blood called creatine phosphokinase (an enzyme released into the blood when muscle is damaged).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TAGRISSO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister foil and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of TAGRISSO

• The active substance is osimertinib (as mesilate). Each 40 mg coated tablet contains 40 mg of osimertinib. Each 80 mg coated tablet contains 80 mg of osimertinib.
• The other components (excipients) 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 “TAGRISSO contains sodium”).

What TAGRISSO looks like and contents of the pack

TAGRISSO 40 mg is supplied as beige, film-coated, round, biconvex tablets, marked with “AZ” and “40” on one side and smooth on the other.

TAGRISSO 80 mg is supplied as beige, film-coated, oval, biconvex tablets, marked with “AZ” and “80” on one side and smooth on the other.

TAGRISSO is supplied in blisters containing 30 x 1 coated tablets, packaged in cartons containing 3 blisters of 10 tablets each.

TAGRISSO is supplied in blisters containing 28 x 1 coated tablets, packaged in cartons containing 4 blisters of 7 tablets each.

Marketing Authorization Holder

AstraZeneca AB
SE‑151 85 Södertälje
Sweden

Manufacturer responsible for manufacturing

AstraZeneca AB
Gärtunavägen
SE‑152 57 Södertälje
Sweden

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu