Tagrisso 80mg Tablet contains osimertinib, a targeted anticancer medicine that belongs to the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) class. It is used in adults with EGFR mutation-positive non-small cell lung cancer (NSCLC) in specific treatment settings, including after surgery, as first-line treatment for advanced disease, and after progression on certain earlier EGFR-targeted treatments.

Osimertinib works by blocking abnormal EGFR signals that help cancer cells grow and spread. Treatment should be started and monitored by an oncologist, as regular monitoring of heart function, blood counts, lung symptoms and other side effects may be required during treatment.

Tagrisso 80mg Tablet is used for:

• EGFR mutation-positive early-stage NSCLC: As adjuvant treatment after complete surgical removal of the tumour.

• EGFR mutation-positive locally advanced or metastatic NSCLC: As first-line treatment.

• EGFR T790M mutation-positive advanced NSCLC: In patients whose cancer has progressed after certain earlier EGFR-targeted therapies.

Tagrisso contains osimertinib, an EGFR tyrosine kinase inhibitor.

It blocks abnormal EGFR proteins that drive the growth and spread of certain lung cancer cells. By inhibiting these signals, osimertinib helps slow tumour growth, reduce tumour size and lower the risk of cancer recurrence after surgery in eligible patients.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Strong CYP3A inducers: Medicines such as rifampicin, phenytoin and carbamazepine may reduce the effectiveness of osimertinib and should generally be avoided.

• Medicines that prolong the QT interval: Some heart medicines, antibiotics and other medicines may increase the risk of abnormal heart rhythms when used with Tagrisso.

• Hormonal contraceptives: Osimertinib may reduce the effectiveness of some hormonal contraceptives, so discuss suitable contraception with your doctor.

• Grapefruit and grapefruit products: These should be avoided unless your doctor advises otherwise.

Do not start any new medicine without informing your doctor.

• Store Tagrisso 80mg Tablet at temperatures below 30°C.

• Keep the tablets in their original packaging.

• Protect from moisture.

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

Take Tagrisso exactly as prescribed by your doctor.

• Take one tablet once daily, with or without food.

• Swallow the tablet whole with water. Do not crush, chew or split it.

• Take it at approximately the same time each day.

• If swallowing is difficult, the tablet may be dispersed in water as instructed by your healthcare provider.

• If you miss a dose, skip it if the next dose is due within 12 hours. Do not take two doses together.

Do not stop treatment unless advised by your doctor.

Common side effects may include:

• Diarrhoea

• Rash

• Dry skin

• Nail changes

• Mouth sores

• Tiredness

• Reduced appetite

• Cough

• Muscle or joint pain

• Low white blood cell counts

• Low platelet counts

• Anaemia

Serious side effects

Seek medical attention immediately if you develop:

• Difficulty breathing with cough or fever

• Heart rhythm problems or reduced heart function

• Severe skin reactions

• Eye problems such as pain or vision changes

• Persistent fever or signs of infection

• Take Tagrisso at the same time every day.

• Attend regular blood tests and heart monitoring appointments.

• Report new cough, fever or breathing difficulty immediately.

• Tell your doctor if you notice vision changes or eye pain.

• Use effective contraception for the recommended period after treatment.

• Do not stop treatment without consulting your oncologist.

• Avoid grapefruit products unless your doctor advises otherwise.