Drug reference

pemgarda

Anti-SARS-CoV-2 spike monoclonal antibody (pemivibart) — passive immunoprophylaxis · Monoclonal antibody (for SARS-CoV-2 prevention)

START

4,500 mg IV over 60 min every 3 months (observe ≥2 h)

TYPICAL MAX

4,500 mg every 3 months

STOP IF

Anaphylaxis / severe infusion reaction

WATCH

Variant-susceptibility status (efficacy depends on prevailing variants)

CDSCO approvedATC J06BD

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 6min · infusion start
PEAK: 1h · end infusion
t½: 4.3w · Fc-ext t½
DURATION: 12.9w · q3-month

EXCRETION

Proteolytic catabolism; not excreted intact

route + CYP

INTERACTIONS

1 major

SEVERE in our sources

PREGNANCY

Use only if clearly needed; limited data.

FDA category + note

Top interactionssee all 5 →

Active Sars Cov 2 InfectionSevereDatabaseKimi deep-research + Cla

Mechanism

Human IgG1 monoclonal antibody binding the SARS-CoV-2 spike receptor-binding domain to block ACE2 engagement; provides passive immunity for moderately-to-severely immunocompromised adults unlikely to respond to vaccination.

Indications

Pre-exposure prophylaxis of COVID-19 in moderately-to-severely immunocompromised adults (when active variants susceptible)

Dosing

Adult: 4,500 mg IV over ~60 min every 3 months (under EUA); observe ≥2 h post-infusion.
Pediatric: Not established.
Renal adjustment: No specific adjustment.
Hepatic adjustment: No specific adjustment.
Geriatric: Standard adult dose.
Max dose: 4,500 mg every 3 months

Pharmacokinetics

Onset

Neutralising titres immediate (post-infusion)

Peak effect

End of infusion

Duration

~3 months (q3-month dosing)

Half-life

Several weeks (engineered Fc-extended)

Bioavailability

IV 100%

Protein binding

Not applicable (antibody)

Metabolism

Proteolytic catabolism

Excretion

Catabolised (not renally/hepatically excreted intact)

Contraindications

Prior severe hypersensitivity to pemivibart or monoclonal antibodies
Active SARS-CoV-2 infection (treatment, not prophylaxis)

Side effects

Common

Infusion reactionsPyrexiaHeadacheFatigueNausea

Serious

Anaphylaxis / serious infusion reactions (boxed)
Severe hypersensitivity

Pregnancy & lactation

Pregnancy

Use only if clearly needed; limited data.

Lactation

Limited data; weigh benefit/risk.

Drug interactions

Active Sars Cov 2 Infection

Severe

Database

EUA is for prophylaxis only, not treatment

Use treatment agents if infected