Osimertinib (Specialist drug)
Brand names: Tagrisso
Osimertinib is an oral third-generation EGFR tyrosine kinase inhibitor used in oncology to treat EGFR-mutation-positive non-small-cell lung cancer, including tumours carrying the T790M resistance mutation; it has no rheumatology role.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
It irreversibly and selectively inhibits sensitising EGFR mutations and the T790M resistance mutation while largely sparing wild-type EGFR, blocking downstream proliferative and survival signalling in tumour cells.
Prescribing in practice
- It can cause QT prolongation and, less commonly, cardiomyopathy with reduced left ventricular ejection fraction, so check ECG and electrolytes and assess cardiac function as advised, and stop for serious arrhythmia or heart failure.
- Interstitial lung disease/pneumonitis is a recognised and potentially fatal effect, so withhold and investigate any new or worsening respiratory symptoms.
- Rare but serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Monitoring
Monitor ECG and electrolytes, periodically assess left ventricular function, and watch closely for respiratory symptoms and severe skin reactions throughout treatment.
Counselling the patient
- Report new breathlessness, cough or fever promptly.
- Tell us about palpitations, fainting or marked swelling.
- Seek advice urgently for any severe or blistering skin rash.
Evidence & guidelines
Efficacy is established by randomised trials showing superior progression-free and overall survival versus earlier EGFR inhibitors in EGFR-mutant lung cancer.
Reference: NICE TA416/TA653; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
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