Patient Information Leaflet

Tagrisso40mg Film-Coated Tablets

Tagrisso80mg Film-Coated Tablets

osimertinib

Read this 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 are unsure about anything, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

OSIMERTINIB is the active ingredient in TAGRISSO, which belongs to a group of medicines calledtyrosine kinase inhibitors, used to treat cancer. TAGRISSO is used to treat adults with a type of lung cancer called "non-small cell lung cancer". It is likely that your cancer will 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 in monotherapy may be prescribed:

• aftercomplete removal of your cancer as adjuvant post-surgical treatment

or

• for a cancer that cannot be removed (resected) by surgery and has responded 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

• in certain circumstances, if you have previously received treatment for your cancer with other tyrosine kinase inhibitors.

TAGRISSO may be prescribed in combination with other cancer medicines, such as:

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

When TAGRISSO is administered in combination with other cancer medicines, it is essential that you also read the leaflet for these other medicines. If you have any questions about these medicines, consult your doctor.

How TAGRISSO works

TAGRISSO acts by blocking the EGFR and may help your non-small cell lung cancer stop growing or slow its growth. It may also help reduce the size of the tumor and prevent the tumor from recurring after surgical removal.

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

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

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

If you have any doubts about how this medicine works, or why you have been prescribed this medicine, consult your doctor.

Do not take TAGRISSO if:

• You are allergic (hypersensitive) to osimertinib or to any of the other components of this medication (listed in section6).
• You are taking St. John's Wort (Hypericum perforatum).

Consult your doctor, pharmacist, or nurse before taking TAGRISSO if you are unsure.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting TAGRISSO if:

• You have had interstitial lung disease (a condition called "interstitial lung disease").
• You have had any heart problems - your doctor may want to closely monitor you.
• You have a history of eye problems.

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

Inform your doctor immediately while taking this medication if:

• You experience sudden difficulty breathing along with cough or fever.
• You have severe skin peeling.
• You have rapid or irregular heartbeats, dizziness, lightheadedness, chest discomfort, difficulty breathing, or fainting.
• You have watery eyes, sensitivity to light, eye pain, eye redness, or changes in vision. For more information, see "Severe side effects" in section4.
• You develop persistent fever, bruising or bleeding easily, increased fatigue, pale skin, or infection. For more information, see "Severe side effects" in section4.

Children and adolescents

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

TAGRISSO with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription and herbal medications. This is because TAGRISSO may affect the way other medications work, and also, other medications may affect TAGRISSO.

Inform your doctor before taking TAGRISSO if you are taking any of the following medications:

The following medications may reduce the effectiveness ofTAGRISSO:

• Phenytoin, carbamazepine, or phenobarbital - used to treat epilepsy or seizures.
• Rifabutin or rifampicin - used to treat tuberculosis (TB).
• St. John's Wort (Hypericum perforatum) - a herbal medication used to treat depression.

TAGRISSO may affect the effectiveness of the following medications and/or increase their side effects:

• Rosuvastatin - used to reduce cholesterol.
• Oral contraceptive pill - used to prevent pregnancy.
• Bosentan - used to treat high blood pressure in the lungs.
• Efavirenz and etravirine - used to treat HIV/AIDS.
• Modafinilo - used to treat sleep disorders.
• Dabigatrán - used to prevent blood clots.
• Digoxina - used to treat irregular heartbeats or other heart problems.
• Aliskireno - used to treat high blood pressure.

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

Pregnancy–information for men

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

Contraception–information for women and men

You should use effective contraception during treatment.

• TAGRISSO may interfere with the proper functioning of oral hormonal contraceptives. Discuss with your doctor the most suitable contraceptive methods.
• TAGRISSO may pass into human semen. Therefore, men should also use an effective contraceptive method.

Additionally, you should also do the following after completing treatment with TAGRISSO:

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

Breastfeeding

Do not breastfeed while taking this medication, as it is unknown whether there is a risk to your baby.

Driving and operating machinery

TAGRISSO does not affect or insignificantly affects your ability to drive and operate machinery.

TAGRISSO contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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 per day when TAGRISSO is administered as monotherapy.
• The recommended dose of TAGRISSO is one 80 mg tablet per day when administered with pemetrexed and chemotherapy containing platinum.
• Your doctor may reduce your dose to one 40 mg tablet per day if necessary.

How to take

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

If you have trouble swallowing the tablet, you can mix it with water:

• Place the tablet in a glass.
• Add 50 ml (about two-thirds of a glass) of water without gas – do not use any other liquid.
• Shake the water until the tablet breaks into very small pieces – the tablet will not dissolve completely.
• Drink the liquid immediately.
• To make sure you have taken all the medication, rinse the glass completely with another 50 ml of water and drink it.

If you take more TAGRISSOthan you should

If you take a larger amount than your usual dose, consult 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 there are less than 12 hours until your next dose, do not take the missed dose. Take the next dose at the usual time.

If you interrupt treatment with TAGRISSO

Do not stop taking this medication – consult your doctor first. It is essential that you take this medication every day, for the time prescribed by your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor immediately if you experience the following severe 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 spots or circular patches, often with central blisters on the trunk, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. Stevens-Johnson syndrome is rare: it may affect up to 1 in 100,000 people. The frequency of toxic epidermal necrolysis cannot be determined since only cases have been reported since the marketing of TAGRISSO.
• Changes in heart electrical activity (QTc prolongation), such as rapid or irregular heartbeats, dizziness, confusion, 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, redness of the eyes, or changes in vision. This side effect is infrequent: 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–the signs that suggest this blood disorder may include persistent fever, bruising or bleeding more easily, increased fatigue, and a decrease in your ability to fight infections. This side effect is rare: it may affect up to 1 in 1,000 people.
• A condition in which the heart does not pump blood out of the heart as well as it should, which could cause difficulty breathing, fatigue, and swelling of the ankles (suggestive of heart failure or left ventricular ejection fraction decreased).

Inform your doctor immediately if you notice the severe side effect mentioned above.

Other side effects

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

• Diarhea - it may appear intermittently during treatment. Inform your doctor if diarrhea does not disappear or worsens.
• Itching on the skin (pruritus) - regular application of moisturizing creams on your skin may help improve this.
• Skin and nail problems - among whose signs are pain, itching, dry skin, skin rash, and redness around the nails of the hands. This is 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 the formation of ulcers in the mouth.
• Loss of appetite.

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

• Lung inflammation caused by radiation therapy in the chest (radiation pneumonitis).
• Nosebleeds (epistaxis).
• Hair loss (alopecia).
• Hives (urticaria) - raised, itchy patches on any part of the skin, which may be pink or red and round in shape. 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.
• Increased levels of a substance in the blood called creatinine (produced by the body and eliminated by the kidney).

• Increased levels of a substance in the blood called creatine phosphokinase (an enzyme that is released into the blood when muscle damage occurs).
• Decreased number of white blood cells in the blood (leukocytes, lymphocytes, or neutrophils).

• Decreased number of platelets in the blood.

Infrequent(may affect up to 1 in 100 people)

• Target lesions, which are skin reactions with a ring-like appearance (suggestive of Erythema multiforme).
• Inflammation of blood vessels in the skin. This may give the appearance of bruises or redness of the skin that does not fade when pressed (does not disappear).
• Muscle inflammation that may cause pain or muscle weakness.
• Greyish or darkened skin (hyperpigmentation).

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

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

• Diarhea - it may appear and disappear during treatment. Inform your doctor if diarrhea does not disappear or worsens.
• Skin and nail problems - among whose signs are pain, itching, dry skin, rash, and redness around the nails of the hands. This is 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 the formation of ulcers in the mouth.
• Loss of appetite.
• Decreased number of white blood cells in the blood (leukocytes, lymphocytes, or neutrophils).
• Decreased number of platelets in the blood.
• Increased levels of a substance in the blood called creatinine (produced by the body and eliminated by the kidney).

Common(may affect up to 1 in 10 people)

• Nosebleeds (epistaxis).
• Itching on the skin (pruritus) - regular application of moisturizing creams on your skin may help improve this.
• Hair loss (alopecia).
• Target lesions, which are skin reactions with a ring-like appearance (suggestive of Erythema multiforme).
• Hives (urticaria) - raised, itchy patches on any part of the skin, which may be pink or red and round in shape. Inform your doctor if you notice this side effect.
• Greyish 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.
• Increased levels of a substance in the blood called creatine phosphokinase (an enzyme that is released into the blood when muscle damage occurs).

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack label and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Compositionof TAGRISSO

• The active ingredient is osimertinib (as mesylate). Each film-coated tablet of 40mg contains 40mg of osimertinib. Each film-coated tablet of 80mg contains 80mg of osimertinib.
• The other components (excipients) are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearate fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, and black iron oxide (see section 2 “TAGRISSO contains sodium”).

Appearance of TAGRISSO and contents of the pack

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

TAGRISSO 80mg 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 film-coated tablets, packed in cartons, containing 3 blisters of 10 film-coated tablets each.

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

Marketing Authorisation Holder

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu