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Pemgarda
pemivibart
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]
Contraindications / Cautions .
- Not FDA Approved: avail. under FDA Emergency Use Authorization
- hypersensitivity to drug or ingredient
- caution: hypersensitivity to COVID-19 vaccine
Drug Interactions .
Overview
pemivibart
SARS-CoV-2-specific monoclonal antibody
- immunomodulatory effects (other)
- FDA Emergency Use Authorization; clinical drug interaction studies not available
Monitor/Modify Tx
- COVID-19 vaccine
Adverse Reactions .
Serious Reactions
- Not FDA Approved: avail. under FDA Emergency Use Authorization
- hypersensitivity rxn
- anaphylaxis
Common Reactions
- Not FDA Approved: avail. under FDA Emergency Use Authorization
- infusion rxn
- URI
- viral infection
- influenza-like sx
- fatigue
- headache
- nausea
Safety/Monitoring .
Not FDA Approved: investigational use only
Info: avail. under FDA Emergency Use Authorization
Monitoring Parameters
s/sx hypersensitivity rxn for at least 2h after infusion
Pregnancy/Lactation .
Pregnancy
Not FDA Approved: investigational use only
Info: avail. under FDA Emergency Use Authorization
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Lactation
Not FDA Approved: investigational use only
Info: avail. under FDA Emergency Use Authorization
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: other; CYP450: none
Excretion: other; Half-life: 44.8 days
Subclass: Coronavirus
Mechanism of Action
binds to SARS-CoV-2 spike protein receptor binding domain, blocking spike protein attachment to human ACE2 receptor (monoclonal antibody)
Formulary .
No Formulary Selected
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