Tagrisso 80 mg is a prescription medicine containing osimertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It is used for specific indications involving EGFR-mutated non-small cell lung cancer (NSCLC). Its prescribing information describes the appropriate patient population, dosage, administration instructions, warnings, precautions, adverse reactions and monitoring requirements.
This page provides a general overview of prescribing considerations. It is not a substitute for the current official prescribing information applicable to the specific product and country. Healthcare professionals should consult the relevant approved product documentation when making prescribing decisions.
1. Medicine Name and Active Ingredient
Brand name: Tagrisso
Active ingredient: Osimertinib
Strength covered on this page: 80 mg
Medicine class: Epidermal growth factor receptor tyrosine kinase inhibitor
Dosage form: Oral tablet, subject to confirmation against the specific product packaging.
Osimertinib is designed to inhibit susceptible mutant EGFR proteins involved in the growth and survival of certain cancer cells. The brand name, strength and formulation should be confirmed on the prescribed product before administration.
2. Approved Therapeutic Uses
Tagrisso is used in defined clinical settings for patients with particular EGFR mutations in NSCLC. Depending on the applicable authorization, treatment indications may include:
- Adjuvant treatment following complete tumor resection in eligible patients with specified EGFR mutations.
- Treatment after definitive chemoradiation in selected patients with unresectable stage III NSCLC harboring an appropriate EGFR mutation.
- First-line treatment of certain patients with locally advanced or metastatic EGFR-mutated NSCLC.
- Treatment of selected patients with EGFR T790M mutation-positive advanced NSCLC following progression on or after prior EGFR-targeted therapy.
- Combination treatment with pemetrexed and platinum-based chemotherapy in certain approved first-line settings.
Not every indication is authorized in every country. The exact mutation requirement, disease stage, prior-treatment criteria and treatment combinations must be checked against the applicable local prescribing information.
3. Patient Selection and Molecular Testing
Patient selection is an essential part of prescribing osimertinib. A diagnosis of NSCLC alone is not sufficient to establish eligibility.
Appropriate molecular testing is used to identify the EGFR mutation relevant to the intended treatment indication. The oncology team considers the molecular result alongside the pathology report, cancer stage, previous treatment, overall clinical condition and treatment goals.
If the test result is unclear or does not establish eligibility, the treating clinician should determine whether further evaluation is appropriate. Patients should not begin treatment based solely on symptoms, family history or another person’s treatment experience.
4. Recommended Dosage
The usual adult dosage described in official prescribing information is 80 mg orally once daily for applicable indications.
The actual regimen depends on the approved indication, combination-treatment plan and individual clinical circumstances. The prescribing clinician may recommend treatment interruption or dose modification if certain adverse reactions occur.
Patients must follow the dose written on their prescription. They should not increase the dose, take extra tablets or make treatment changes independently.
Where dose modification is necessary, the healthcare professional should follow the relevant product-specific guidance and assess whether treatment should continue, be interrupted or be discontinued.
5. Administration Instructions
Tagrisso is administered orally. Patients should follow the instructions supplied with their prescribed product and confirm any uncertainty with a pharmacist or oncology professional.
Important administration considerations include:
- Take the medicine according to the prescribed schedule.
- Follow the current patient leaflet for instructions concerning food and administration.
- Do not take an additional dose to compensate for a missed dose.
- If vomiting occurs after a dose, consult the patient leaflet or healthcare team rather than automatically repeating the dose.
- Do not alter the tablet or administration method unless the official instructions or healthcare professional permit it.
- Keep the medicine in its recommended packaging and follow the stated storage conditions.
The patient’s prescription and product-specific leaflet take precedence over general online instructions.
6. Contraindications and Precautions
The official prescribing information should be consulted for formal contraindications applicable to the particular product and jurisdiction. Before prescribing, the healthcare professional should assess relevant medical history, potential interactions and individual risks.
Important precautions include the possibility of serious pulmonary toxicity, heart rhythm abnormalities, cardiomyopathy, eye inflammation and hematologic complications. The risks and required monitoring may differ according to the patient’s condition and other medicines.
Patients should tell their healthcare professional about previous serious medicine reactions and any significant heart, lung or eye conditions. They should also disclose all prescription medicines, nonprescription products, supplements and herbal remedies they use.
7. Serious Warnings and Adverse Reactions
Osimertinib can cause serious adverse reactions that require prompt medical assessment.
Interstitial lung disease or pneumonitis: New or worsening cough, shortness of breath, fever or other respiratory symptoms may require urgent assessment. The clinician should evaluate suspected pulmonary toxicity and follow the official guidance on treatment interruption or discontinuation.
QT interval prolongation: Osimertinib may affect cardiac electrical activity. Patients with relevant risk factors or concomitant medicines may require electrocardiographic monitoring and assessment of electrolytes.
Cardiomyopathy: Changes in heart function may occur. The need for cardiac assessment and monitoring should be determined according to the prescribing information and individual risk.
Keratitis and other eye problems: Eye pain, redness, light sensitivity or visual changes should be reported promptly.
Aplastic anemia: This rare but serious hematologic risk requires clinical attention when suspected. Patients should report unusual bruising, bleeding, marked fatigue or other concerning symptoms.
Severe or rapidly worsening symptoms may require emergency medical care.
8. Common Adverse Reactions
Commonly reported adverse reactions include diarrhea, rash, dry skin, nail changes and stomatitis or other mouth inflammation. The frequency and severity of reactions depend on the patient and treatment setting.
Patients should report persistent diarrhea, difficulty maintaining hydration, painful skin reactions, mouth sores or symptoms that interfere with normal activities. Healthcare professionals can determine whether supportive care, additional investigation or treatment modification is appropriate.
A list of common reactions is not a complete list of all possible adverse effects. The current official product information should be reviewed for the complete safety profile.
9. Drug Interactions
The patient’s complete medication list should be reviewed before treatment begins and whenever another medicine is added or discontinued.
Particular attention may be needed for medicines that affect cardiac rhythm, have overlapping toxicities or alter the safety of the treatment regimen. The clinical significance of an interaction depends on the specific medicine, dose and patient factors.
Patients should not discontinue prescribed medicines or begin supplements without professional guidance. A pharmacist or oncology specialist can review potential interactions and determine whether additional precautions are necessary.
10. Pregnancy, Breastfeeding and Fertility Considerations
Osimertinib may cause fetal harm. Pregnancy status, pregnancy planning and appropriate precautions should be discussed with the prescribing clinician before treatment begins.
Patients who are pregnant or think they may be pregnant should promptly contact their healthcare team. The official prescribing information should be consulted for current contraception requirements and relevant precautions for patients and their partners.
Breastfeeding also requires specific medical advice. Patients should discuss the risks and applicable restrictions with their healthcare professional before making decisions about treatment or breastfeeding.
11. Monitoring During Treatment
Monitoring should be individualized according to the treatment indication, patient risk factors, concomitant medicines and official product guidance.
The healthcare team may assess:
- Treatment response using clinical evaluation and appropriate imaging.
- Respiratory symptoms that may indicate pulmonary toxicity.
- Cardiac risk and the need for electrocardiography or heart-function assessment.
- Electrolytes and other laboratory parameters where clinically indicated.
- Eye symptoms and other suspected adverse reactions.
- Adherence, tolerability and any need for dose modification.
Patients should attend scheduled appointments and report new symptoms promptly. Monitoring plans may change as the patient’s clinical circumstances evolve.
12. Overdose and Missed Doses
If a patient takes more than the prescribed amount, they should contact a healthcare professional or local poison-information service promptly for advice. Severe symptoms require emergency assistance. Patients should not attempt to manage a suspected overdose solely through online information.
For a missed dose, follow the instructions in the current patient leaflet. Do not double the next dose unless specifically directed by a qualified healthcare professional under applicable guidance.
13. Storage and Product Handling
Store Tagrisso according to the instructions on the specific package and patient leaflet. Check the expiry date before use and keep the medicine away from children.
Do not use a product that is expired, damaged or of uncertain identity. Patients should consult a pharmacist if the package appears tampered with or if the medicine may have been exposed to unsuitable storage conditions.
Packaging checks can identify discrepancies but cannot independently guarantee product authenticity. Obtain prescription medicines through legitimate supply channels.
14. Prescriber and Patient Responsibilities
The prescriber is responsible for determining eligibility, selecting the appropriate regimen, reviewing relevant risks and arranging suitable monitoring. Patients are responsible for following their prescribed instructions, providing accurate information about other medicines and reporting concerning symptoms.
Patients should receive clear instructions about administration, missed doses, potential side effects, interactions and whom to contact if a problem occurs. They should ask for clarification whenever the prescription, package label or treatment instructions appear inconsistent.
Conclusion
Tagrisso 80 mg contains osimertinib, a targeted EGFR inhibitor used for specific forms of EGFR-mutated NSCLC. Appropriate prescribing requires molecular confirmation, assessment of the applicable indication, individualized dosage instructions, review of interactions and continued safety monitoring.
Because indications, warnings and administration requirements can vary with the applicable authorization, healthcare professionals should consult the current official prescribing information for the specific product and jurisdiction.
Medical Disclaimer: This page is for general educational purposes only. It is not an official prescribing document and does not replace the current approved product information or professional medical judgment. Tagrisso must be prescribed and monitored by a qualified healthcare professional. Patients should not initiate, modify or discontinue treatment without medical advice and should seek urgent assessment for serious or rapidly worsening symptoms.