Indications & Dose:

Treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged twelve years and older with body weight at least 40

kilograms (88 lb)) with pneumonia requiring supplemental oxygen and requiring hospitalization. injection, lyophilized powder for reconstitution

100mg/vial injection, concentrated solution 100mg/20mL (5mg/mL)

Coronavirus Disease 2019 (COVID-19)

Indicated for adults and pediatric patients aged =12 years who weigh =40 kg for treatment of COVID-19 requiring hospitalization\Day 1 loading

dose: 200 mg IV infused over 30-120 min, THEN Day 2 and thereafter: 100 mg IV qDay

Treatment duration

Not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; if clinical improvement not

demonstrated, treatment may be extended up to 10 days total Requires invasive mechanical ventilation and/or ECMO: 10 days

Contraindications:

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Renal impairment

Pharmacokinetics have not been evaluated in patients with renal impairment eGFR =30 mL/min: No dose adjustment eGFR<30 mL/min: Not

recommended; sulfobutylether-beta-cyclodextrin sodium salt (SBECD) excipient in the concentrated solution is renally cleared and accumulates in

patients with decreased renal function

Hepatic impairment

Not evaluated; unknown if dosage adjustment required Dosing Considerations

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: