Pemgarda

Adult Dosing .

Dosage forms:  INJ

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: for COVID-19 pre-exposure prophylaxis in pts w/ moderate-severe immune compromise unlikely to mount adequate immune response to COVID-19 vaccines; not FDA approved; for clinical trial eligibility and enrollment info, check www.clinicaltrials.gov

[mandatory reporting for EUA]

Info: serious medication errors and adverse events must be reported to FDA MedWatch (www.fda.gov/medwatch/report.htm or 1-800-FDA-1088) and Invivyd, Inc. (1-800-890-3385)

COVID-19 pre-exposure prophylaxis

[4500 mg IV x1 dose]

Info: for pts w/ moderate-severe immune compromise unlikely to mount adequate immune response to COVID-19 vaccines; may repeat dose q3mo

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]

Peds Dosing .

Dosage forms:  INJ

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: for COVID-19 pre-exposure prophylaxis in pts w/ moderate-severe immune compromise unlikely to mount adequate immune response to COVID-19 vaccines; not FDA approved; for clinical trial eligibility and enrollment info, check www.clinicaltrials.gov

[mandatory reporting for EUA]

Info: serious medication errors and adverse events must be reported to FDA MedWatch (www.fda.gov/medwatch/report.htm or 1-800-FDA-1088) and Invivyd, Inc. (1-800-890-3385)

COVID-19 pre-exposure prophylaxis

[12 yo and older, >40 kg]

Dose: 4500 mg IV x1 dose; Info: for pts w/ moderate-severe immune compromise unlikely to mount adequate immune response to COVID-19 vaccines; may repeat dose q3mo

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]