Osinib 80 mg Tablet

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. See full prescribing information for TAGRISSO. TAGRISSO® (osimertinib) tablets, for oral use Initial U.S. Approval: 2015 ---------------------------RECENT MAJOR CHANGES--------------------------- Indications and Usage (1.1) 4/2018 Dosage and Administration (2.4) 4/2018 Warnings and Precautions (5.3, 5.5) 4/2018 --------------------------- INDICATIONS AND USAGE -------------------------- TAGRISSO is a kinase inhibitor indicated for  the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. (1.1, 2.1)  the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. (1.2, 2.1) ---------------------- DOSAGE AND ADMINISTRATION ---------------------- Recommended dosage: 80 mg orally once daily, with or without food. (2.2) --------------------- DOSAGE FORMS AND STRENGTHS -------------------- Tablets: 80 mg and 40 mg. (3) ------------------------------ CONTRAINDICATIONS ----------------------------- None. (4) ----------------------- WARNINGS AND PRECAUTIONS ----------------------  Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.9% of patients. Permanently discontinue TAGRISSO in patients diagnosed with ILD/Pneumonitis. (5.1)  QTc Interval Prolongation: Monitor electrocardiograms and electrolytes in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Withhold then restart at a reduced dose or permanently discontinue TAGRISSO. (2.4, 5.2)  Cardiomyopathy: Occurred in 2.6% of patients. Conduct cardiac monitoring, including left ventricular ejection fraction (LVEF) assessment in patients with cardiac risk factors. (2.4, 5.3)  Keratitis: Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation. (5.4)  Embryo-Fetal Toxicity: TAGRISSO can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with TAGRISSO and for 6 weeks after final dose. Advise males to use effective contraception for 4 months, after the last dose of TAGRISSO. (5.5, 8.1, 8.3) ------------------------------ ADVERSE REACTIONS ----------------------------- Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or www.TAGRISSO.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------ DRUG INTERACTIONS ----------------------------- Strong CYP3A Inducers: Avoid if possible. If not possible, increase TAGRISSO to 160 mg daily in patients receiving a strong CYP3A4 inducer. (2.4, 7.1) ------------------------USE IN SPECIFIC POPULATIONS----------------------- Lactation: Do not breastfeed. (8.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 8/2018