IMPORTANT SAFETY INFORMATION
• There are no contraindications for TAGRISSO
• Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.5% and was fatal in 0.6% of 833 TAGRISSO-treated
patients. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of
respiratory symptoms indicative of ILD (eg, dyspnea, cough, and fever). Permanently discontinue TAGRISSO
if ILD is con;rmed
• Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 833
TAGRISSO-treated patients, 0.7% of patients were found to have a QTc > 500 msec, and 2.9% of patients
had an increase from baseline QTc > 60 msec. No QTc-related arrhythmias were reported. Conduct periodic
monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart
failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval.
Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms
of life-threatening arrhythmia
• Cardiomyopathy occurred in 1.9% and was fatal in 0.1% of 833 TAGRISSO-treated patients. Left Ventricular
Ejection Fraction (LVEF) decline ≥ 10% and a drop to < 50% occurred in 4% of 655 TAGRISSO-treated patients.
Conduct cardiac monitoring, including an assessment of LVEF at baseline and during treatment in patients with
cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment.
For symptomatic congestive heart failure or persistent, asymptomatic LV dysfunction that does not resolve within
4 weeks, permanently discontinue TAGRISSO
• Keratitis was reported in 0.7% of 833 TAGRISSO-treated patients in clinical trials. Promptly refer patients with
signs and symptoms suggestive of keratitis (such as eye in;ammation, lacrimation, light sensitivity, blurred vision,
eye pain, and/or red eye) to an ophthalmologist
• Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective
contraception during TAGRISSO treatment and for 6 weeks after the ;nal dose. Advise males with female
partners of reproductive potential to use effective contraception for 4 months after the ;nal dose
• The most common adverse reactions (≥20%) in patients treated with TAGRISSO were diarrhea (41%), rash (34%),
dry skin (23%), nail toxicity (22%), and fatigue (22%)
TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M
mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has
progressed on or after EGFR tyrosine kinase inhibitor therapy.
Please see Brief Summary of complete Prescribing Information on adjacent pages.
Reference: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.