Locally advanced or metastatic NSCLC w/ activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
IV infusion Adult ≥18 yr, ≥80 kg 1,400 mg wkly for wk 1-4 (total of 4 doses), then every 2 wk starting wk 5, <80 kg 1,050 mg wkly for wk 1-4 (total of 4 doses), then every 2 wk starting wk 5.
Discontinue use if grade 3 or 4 infusion-related reactions (IRRs) occur; ILD, TEN. Rash including dermatitis acneiform, pruritus & dry skin; eye disorders eg, keratitis. Monitor patients for symptoms indicative of ILD/pneumonitis; administer premed to reduce risk of IRRs. Withhold, reduce or discontinue use based on severity of skin & nail reactions. Promptly refer patients w/ worsening eye symptoms to ophthalmologist. Limit sun exposure during & 2 mth after therapy. May affect ability to drive & use machines. Severe renal & hepatic impairment. Women of childbearing potential & male partners should use effective contraception during & for 3 mth after last dose. Not to be used during pregnancy. Not to be used during lactation & for 3 mth after last dose. Ped ≤17 yr.
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