Tagrisso Generic Name & Formulations
Mechanism of Action
Tagrisso Dosage and Administration
Tagrisso Boxed Warnings
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. Promptly refer to an ophthalmologist if signs/symptoms suggestive of keratitis occur. Withhold dose if aplastic anemia, erythema multiforme major, Stevens-Johnson Syndrome, or toxic epidermal necrolysis is suspected; permanently discontinue if confirmed. Withhold dose and evaluate if cutaneous vasculitis suspected; consider permanent discontinuation based on severity if no other etiology. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 weeks (females) or 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Median time to maximal plasma concentration (Cmax): 6 hours (range 3–24 hours).
Mean volume of distribution at steady-state (Vss/F): 918 L.
Plasma protein bound: 95%.
Fecal (68%), renal (14%).
Half-life: 48 hours.
Tagrisso Adverse Reactions
Tagrisso Clinical Trials
Tagrisso Patient Counseling