Generic Name and Formulations:
Osimertinib 40mg, 80mg; tabs.
- FDA Accepts Supplemental New Drug Application for Osimertinib as First-line Treatment in EGFR-mutant NSCLC
- Osimertinib Granted Breakthrough Therapy Designation as First-line Treatment for EGFR-positive NSCLC
- FDA Approves Osimertinib for EGFR T790M Mutation-positive NSCLC
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Indications for TAGRISSO:
First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
Confirm presence of exon 19 deletion or exon 21 L858R or T790M mutation prior to treatment initiation. 80mg once daily until disease progression or unacceptable toxicity. If swallowing difficulty, may disperse tab in 2oz (60mL) of non-carbonated water only; stir and swallow immediately, then rinse container with 4–8oz water and drink immediately; or if administration via NG tube is required, disperse tab in 15mL of non-carbonated water and use an additional 15mL of water to transfer any residues to the syringe; give resulting 30mL via NG tube as instructed with appropriate water flushes (~30mL). Concomitant strong CYP3A4 inducers (if use is unavoidable): increase dose to 160mg daily; resume at 80mg 3 weeks after discontinuing CYP3A4 inducer. Dose modification: see full labeling.
Permanently discontinue if interstitial lung disease (ILD)/pneumonitis is confirmed; QTc interval prolongation with signs/symptoms of life-threatening arrhythmia; symptomatic CHF; or if no improvement within 3 weeks. Withhold dose if worsening respiratory symptoms indicative of ILD occur; if QTc interval >500msec on ≥2 separate ECGs; or adverse reactions of Grade ≥3 severity. Monitor ECGs and electrolytes periodically in patients with congenital long QTc syndrome, CHF, electrolyte abnormalities, or those who are taking drugs known to prolong the QTc interval. Conduct cardiac monitoring (including LVEF at baseline and during treatment) in patients with cardiac risk factors; assess LVEF if relevant cardiac signs/symptoms occur. Evaluate if signs/symptoms of keratitis occur. ESRD. Severe hepatic impairment. Embryo-fetal toxicity. Use effective contraception during and for 6 weeks (females) or 4 months (males) after final dose. Pregnancy; verify status before initiation. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Antagonized by strong CYP3A inducers (eg, rifampin); avoid; if use is unavoidable, increase Tagrisso dose (see Adults). Potentiates BCRP (eg, rosuvastatin) or P-gp (eg, fexofenadine) substrates; monitor closely for related toxicity. Avoid concomitant QT-prolonging drugs.
Diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, decreased appetite, lab abnormalities; possibly infertility.
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