دواعي استعمال تاجريسو 80مجم 30 قرص

Osimertinib 80 mg film-coated tablets, pack of 30 (3 strips) (AstraZeneca).

• Adjuvant therapy after tumour resection in NSCLC with EGFR exon 19 deletions or exon 21 L858R mutationsالفئة: AdultsDailyMed (NLM)
• Locally advanced unresectable (stage III) EGFR-mutated NSCLC not progressed after platinum-based chemoradiationالفئة: AdultsDailyMed (NLM)
• First-line metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations (monotherapy or with pemetrexed and platinum chemotherapy)الفئة: AdultsDailyMed (NLM)
• Metastatic EGFR T790M mutation-positive NSCLC progressed on or after EGFR TKI therapyالفئة: AdultsDailyMed (NLM)

• Most common (>=20%) with monotherapy: leukopenia, lymphopenia, thrombocytopenia, anaemia, diarrhoea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, fatigue.نشرة دولية لنفس التركيبة · DailyMed (NLM)

• None listed in the US label.نشرة دولية لنفس التركيبة · DailyMed (NLM)

• Interstitial lung disease/pneumonitis: monitor; permanently discontinue if diagnosed (rules differ after recent chemoradiation).نشرة دولية لنفس التركيبة · DailyMed (NLM)
• QTc prolongation: monitor ECG and electrolytes in at-risk patients; withhold, reduce or discontinue by severity.نشرة دولية لنفس التركيبة · DailyMed (NLM)
• Cardiomyopathy (3.8%): assess LVEF in patients with cardiac risk factors.نشرة دولية لنفس التركيبة · DailyMed (NLM)
• Keratitis; erythema multiforme major, Stevens-Johnson syndrome, toxic epidermal necrolysis; cutaneous vasculitis; aplastic anaemia; myositis with CPK elevation; embryo-fetal toxicity.نشرة دولية لنفس التركيبة · DailyMed (NLM)

• Strong CYP3A inducersAvoid; if unavoidable increase osimertinib to 160 mg daily.DailyMed (NLM)
• BCRP or P-gp substratesOsimertinib increases their exposure; monitor for substrate toxicity.DailyMed (NLM)

• Can cause fetal harm based on animal data and mechanism; embryolethality and reduced fetal growth in rats at about 1.5 times clinical exposure.نشرة دولية لنفس التركيبة · DailyMed (NLM)
• Advise women not to breastfeed during treatment and for 2 weeks after the last dose.نشرة دولية لنفس التركيبة · DailyMed (NLM)

• Before starting: complete blood count with differential; cardiac assessment including LVEF in patients with cardiac risk factors; EGFR mutation testing with an approved test.نشرة دولية لنفس التركيبة · DailyMed (NLM)

• Binds irreversibly to mutant EGFR (T790M, L858R, exon 19 deletions) at about 9-fold lower concentrations than wild-type (US TAGRISSO label).