TAGRISSO contains the active substance osimertinib, which belongs to the protein kinase inhibitor class of anticancer medicines. TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’ when the tumour has a defect (mutation) in a gene called EGFR (epidermal growth factor receptor). It is used when your cancer is advanced and is worsening.

TAGRISSO can be prescribed for you:

• If you test positive for an ‘exon 19 deletion’ or an ‘exon 21 (L858R) substitution mutation’ – for the initial treatment of your cancer.
  or
• If you test positive for the ‘T790M mutation’ – you may have been treated 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 growing. It may also help to shrink the tumour.

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

Warnings and precautions

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

• You have a history of inflamed lungs (a condition called ‘interstitial lung disease’)
• You have ever had heart problems – your doctor may want 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 with a cough or fever. See Serious side effects for more information.
• You have new or worsening shortness of breath, cough, tiredness, sudden weight gain or swelling of your feet, ankles or legs.
• You develop problems with your eyes such as eye pain, watery eyes, redness, blurred vision or sensitivity to light. See Serious side effects 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 increase side effects of these medicines:

• Warfarin – used for blood clots.
• Phenytoin and S-mephenytoin – used for seizures or fits.
• Alfentanil, fentanyl and other painkillers used for operations.
• 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.

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.

Pregnancy – information for men

If your female partner becomes pregnant while you are taking this medicine, tell your doctor straight away.

Contraception – information for women and men

Women must use effective contraception during treatment.

 

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 your last dose of TAGRISSO.

Men – keep using contraception for 4 months after your last dose of TAGRISSO.

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.

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 about the same time.
• You can take this medicine with or without food.

If you have trouble swallowing the tablet, you can dissolve 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 is in 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 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed on this website.

Serious side effects

Tell your doctor straight away if you notice the following serious side effects:

• Sudden difficulty in breathing 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 and can be fatal. Your doctor may wish to stop TAGRISSO if you get this side effect. This side effect is common: may affect up to 1 in 10 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 effect 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 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.
• Reduction in the number of white blood cells (leukocytes or neutrophils) in the blood.
• Reduction in the number of platelets in the blood.

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 on this website. By reporting side effects, you can help provide more information on the safety of this medicine.

• 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.

What TAGRISSO contains

• The active substance is osimertinib (as mesylate). Each tablet contains 40 mg or 80 mg of osimertinib.
• The other ingredient(s) 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.

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 x 1 film-coated tablets, packed in cartons containing 3 blisters strips of 10 tablets each.

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