Imfinzi

Adult Dosing .

Dosage forms:  INJ

Restricted Distribution in US

[1-844-275-2360 or www.imfinzi.com for more info]

Special Note

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments

non-small cell lung CA

[resectable dz, neoadjuvant tx, <30 kg]

Dose: 20 mg/kg/dose IV q3wk for up to 4 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen

[resectable dz, neoadjuvant tx, >30 kg]

Dose: 1500 mg IV q3wk for up to 4 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen

[resectable dz, adjuvant tx, <30 kg]

Dose: 20 mg/kg/dose IV q4wk for up to 12 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations

[resectable dz, adjuvant tx, >30 kg]

Dose: 1500 mg IV q4wk for up to 12 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations

[stage III unresectable dz, <30 kg]

Dose: 10 mg/kg/dose IV q2wk for up to 12mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT

[stage III unresectable dz, >30 kg]

Dose: 10 mg/kg/dose IV q2wk for up to 12mo; Alt: 1500 mg IV q4wk for up to 12mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT

[metastatic dz, <30 kg]

Dose: 20 mg/kg/dose IV q3wk x4 cycles on wk 0, 3, 6, 9, then 20 mg/kg/dose IV q4wk starting cycle 5 on wk 12; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen

[metastatic dz, >30 kg]

Dose: 1500 mg IV q3wk x4 cycles on wk 0, 3, 6, 9, then 1500 mg IV q4wk starting cycle 5 on wk 12; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen

small cell lung CA

[limited stage dz, <30 kg]

Dose: 20 mg/kg/dose IV q4wk for up to 24mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT

[limited stage dz, >30 kg]

Dose: 1500 mg IV q4wk for up to 24mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT

[extensive-stage dz, first-line tx, <30 kg]

Dose: 20 mg/kg/dose IV q3wk x4 cycles as part of multi-drug chemo regimen, then 10 mg/kg/dose IV q2wk as monotherapy

[extensive-stage dz, first-line tx, >30 kg]

Dose: 1500 mg IV q3wk x4 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy

biliary tract CA, locally advanced or metastatic

[<30 kg]

Dose: 20 mg/kg/dose IV q3wk for up to 8 cycles as part of multi-drug chemo regimen, then 20 mg/kg/dose IV q4wk as monotherapy

[>30 kg]

Dose: 1500 mg IV q3wk for up to 8 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy

hepatocellular CA, unresectable

[<30 kg]

Dose: 20 mg/kg/dose IV x1 on day 1 of cycle 1 w/ tremelimumab, then 20 mg/kg/dose IV q4wk as monotherapy

[>30 kg]

Dose: 1500 mg IV x1 on day 1 of cycle 1 w/ tremelimumab, then 1500 mg IV q4wk as monotherapy

mismatch repair deficient endometrial CA, advanced or recurrent

[<30 kg]

Dose: 15 mg/kg/dose IV q3wk x6 cycles as part of multi-drug chemo regimen, then 20 mg/kg/dose IV q4wk as monotherapy

[>30 kg]

Dose: 1120 mg IV q3wk x6 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy

renal dosing

[see below]

CrCl >30: no adjustment; CrCl <30: not defined

HD/PD: not defined

hepatic dosing

[see below]

bilirubin 1.1-3x ULN: no adjustment; bilirubin >3x ULN: not defined

Peds Dosing .

Peds dosing is currently unavailable or not applicable for this drug.