Tagrisso

Tagrisso

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Osimertinib
Indications/Uses
Adjuvant therapy after tumour resection of adult patients w/ NSCLC w/ EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. 1st-line treatment of adult patients w/ locally advanced or metastatic NSCLC w/ EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Treatment of adult patients w/ locally advanced or metastatic EGFR T790M mutation +ve NSCLC whose disease has progressed on or after EGFR TKI therapy.
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, tab may be dispersed in 50 mL non-carbonated water & stir w/o crushing until dispersed. Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via nasogastric tube by using 15 mL for initial dispersion & 15 mL for residue rinses. The tube should be flushed w/ water after administration. Administer soln w/in 30 min after prep.
Contraindications
Hypersensitivity. Not to be used w/ St. John's wort.
Special Precautions
Discontinue use if ILD is diagnosed, signs & symptoms of SJS appears, QTc interval prolongation in combination w/ Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia develops & aplastic anaemia is confirmed. Avoid use in patients w/ congenital long QT syndrome. Keratitis. Determine EGFR mutation +ve status prior to treatment. Periodically monitor ECG & electrolytes in patients w/ CHF, electrolyte abnormalities or those taking QTc prolonging medicinal products. Perform cardiac monitoring & LVEF assessment in patients w/ cardiac risk factors & conditions affecting LVEF. Low body wt <50 kg. Not recommended in severe hepatic impairment. Severe renal impairment, ESRD. May impair fertility. Women of childbearing potential must use effective contraception at least 2 mth & at least 4 mth for men after treatment completion. Not to be used during pregnancy & lactation. Childn or adolescents <18 yr. Elderly >65 yr.
Adverse Reactions
Decreased appetite; diarrhoea, stomatitis; rash, paronychia, dry skin, pruritus; decreased leucocytes, lymphocytes, platelet count & neutrophils. Epistaxis, ILD; alopecia, urticaria, palmar-plantar erythrodysaesthesia syndrome; increased blood creatinine.
Drug Interactions
Decreased exposure by strong (eg, phenytoin, rifampicin, carbamazepine) & moderate (eg, bosentan, efavirenz, etravirine, modafinil) CYP3A4 inducers. Increased exposure of BCRP & P-gp substrates (eg, digoxin, dabigatran, aliskiren). Increased AUC & Cmax of rosuvastatin, fexofenadine. Decreased AUC & Cmax of simvastatin.
MIMS Class
Targeted Cancer Therapy
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
3 × 10's
Form
Tagrisso FC tab 80 mg
Packing/Price
3 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in