Four Star
Concise Prescribing Info
Osimertinib mesylate
1st-line treatment of adult patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating epidermal growth factor receptor (EGFR) mutations. Treatment of adult patients w/ locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Dosage/Direction for Use
80 mg once daily. May be reduced to 40 mg once daily, if necessary.
May be taken with or without food: Take at the same time each day. Swallow whole, do not crush/split/chew. For patients w/ swallowing difficulties, disperse tab in 50 mL non-carbonated water & stir w/o crushing then, drink immediately. Rinse glass w/ another ½ glass of water & drink. Mixt may also be administered via nasogastric tube by using 15 mL for initial dispersion & 15 mL for residue rinses. Flush tube w/ water after administration.
Hypersensitivity. Co-administration w/ St. John's wort.
Special Precautions
Determine EGFR mutation positive status prior to treatment. Perform careful assessment of patients w/ acute onset &/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) to exclude interstitial lung disease (ILD); permanently discontinue if ILD occurs. QTc interval prolongation. Consider cardiac monitoring & LVEF assessment in patients w/ cardiac risk factors & conditions affecting LVEF. Reports of keratitis. Closely monitor elderly patients >65 yr & patients w/ low body wt (<50 kg). Advise patients to use effective contraception for at least 2 mth for females & 4 mth for males after treatment completion. Avoid pregnancy to women of childbearing potential. Not to be used during pregnancy & lactation.
Adverse Reactions
Diarrhoea, stomatitis; rash, dry skin, paronychia, pruritus; decreased platelet count, leukocytes, lymphocytes & neutrophils. Interstitial lung disease.
Drug Interactions
Decreased exposure w/ strong CYP3A4 inducers (eg, phenytoin, rifampicin & carbamazepine) & moderate CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil). Increased exposure of sensitive BCRP substrates (eg, rosuvastatin); P-gp substrates (eg, fexofenadine); medications w/ narrow therapeutic index (eg, digoxin, dabigatran, aliskiren). Risk for decreased exposure of hormonal contraceptives cannot be excluded.
ATC Classification
L01EB04 - osimertinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Tagrisso FC tab 40 mg
Tagrisso FC tab 80 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in