Tagrisso Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Osimertinib

Indications/Uses

Monotherapy or in combination w/ pemetrexed & platinum-based chemotherapy for 1st-line treatment of adults w/ locally advanced or metastatic NSCLC w/ EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Adults w/ locally advanced or metastatic EGFR T790M mutation +ve NSCLC whose disease has progressed on or after EGFR TKI therapy. Adjuvant therapy after tumour resection of adults w/ NSCLC w/ EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

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Dosage/Direction for Use

80 mg once daily, may be reduced to 40 mg once daily if necessary.

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Overdosage

View Tagrisso overdosage for action to be taken in the event of an overdose.

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, 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. Flush tube w/ water after administration & administer soln w/in 30 min after prep.

Contraindications

Hypersensitivity. Not to be used w/ St. John's wort.

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Special Precautions

Discontinue use if ILD is diagnosed, signs & symptoms suggestive 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.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased appetite; diarrhoea, stomatitis; rash, paronychia, dry skin, pruritus; decreased leucocytes, lymphocytes, platelet count & neutrophils. Leukopenia, lymphopenia, thrombocytopenia, neutropenia; epistaxis, ILD; alopecia, palmar-plantar erythrodysaesthesia syndrome, urticaria, skin hyperpigmentation; decreased left ventricular fraction, QTc interval prolongation, increased blood creatine phosphokinase & creatinine. Cardiac failure; erythema multiforme.

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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 & C_max of rosuvastatin, fexofenadine. Decreased AUC & C_max of simvastatin.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Tagrisso detailed prescribing information

Storage

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Description

View Tagrisso description for details of the chemical structure and excipients (inactive components).

Action

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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.

Regulatory Classification

Presentation/Packing

Form

Tagrisso FC tab 40 mg

Packing/Price

3 × 10's

Form

Tagrisso FC tab 80 mg

Packing/Price

3 × 10's

Tagrisso

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma