Tagrisso泰瑞沙

Tagrisso

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Osimertinib mesylate
Indications/Uses
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.
Administration
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.
Contraindications
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.
Presentation/Packing
Form
Tagrisso FC tab 40 mg
Packing/Price
30's
Form
Tagrisso FC tab 80 mg
Packing/Price
30's
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