Usual Adult Dose for COVID-19

Loading dose (Day 1): 200 mg IV as a single dose
Maintenance dose (from Day 2): 100 mg IV once a day

Duration of Therapy:

• Hospitalized patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 10 days total
• Hospitalized patients not requiring invasive mechanical ventilation and/or ECMO: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown
• Nonhospitalized patients: 3 days total

• Hospitalized, or
• Not hospitalized, have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death

Usual Pediatric Dose for COVID-19

28 Days of Age and Older:
Weight 3 to less than 40 kg:

• Loading dose (Day 1): 5 mg/kg IV as a single dose
• Maintenance dose (from Day 2): 2.5 mg/kg IV once a day

• Loading dose (Day 1): 200 mg IV as a single dose
• Maintenance dose (from Day 2): 100 mg IV once a day

• Hospitalized patients requiring invasive mechanical ventilation and/or ECMO: 10 days total
• Hospitalized patients not requiring invasive mechanical ventilation and/or ECMO: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown
• Nonhospitalized patients: 3 days total

• The lyophilized powder formulation is the only approved dosage form for pediatric patients weighing 3 to less than 40 kg.

• Hospitalized, or
• Not hospitalized, have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death

Renal Dose Adjustments

Estimated GFR less than 30 mL/min: Not recommended.

Comments:

• Pharmacokinetics of this drug have not been evaluated in patients with renal dysfunction.
• All patients must have eGFR determined before starting this drug and should be monitored while receiving this drug as clinically appropriate.
• The excipient betadex sulfobutyl ether sodium is renally cleared and accumulates in patients with reduced renal function; administration of drugs formulated with betadex sulfobutyl ether sodium (such as this drug) is not recommended in patients with eGFR less than 30 mL/min.

Liver Dose Adjustments

Liver dysfunction: Data not available

During therapy:

• If ALT levels increase to greater than 10 times the upper limit of normal: Discontinuation of this drug should be considered.
• If ALT elevation occurs with signs/symptoms of liver inflammation: This drug should be discontinued.

• Pharmacokinetics of this drug have not been evaluated in patients with liver dysfunction.
• Hepatic laboratory testing should be performed in all patients before starting this drug and while receiving this drug as clinically appropriate.

Precautions

CONTRAINDICATIONS:
History of clinically significant hypersensitivity reactions to the active component or any of the ingredients

Safety and efficacy have not been established in pediatric patients younger than 28 days or weighing less than 3 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Determine eGFR and prothrombin time in all patients before starting this drug and monitor during therapy as clinically appropriate.
• Perform hepatic laboratory testing in all patients before starting this drug and during therapy as clinically appropriate.
• Administer only in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction (e.g., anaphylaxis) and the ability to activate the emergency medical system, as needed.
• Start this drug as soon as possible after symptomatic COVID-19 has been diagnosed (hospitalized and nonhospitalized patients) and within 7 days of symptom onset (nonhospitalized patients).
• Administer by IV infusion only; do not administer by any other route.
• Infuse IV over 30 to 120 minutes; consult the manufacturer product information for recommended infusion rates.
• Do not administer the prepared diluted solution simultaneously with any other medication.
• Monitor patients during infusion and observe patients for at least 1 hour after infusion is complete for signs/symptoms of hypersensitivity as clinically appropriate.

• Injection Solution: Store vials in refrigerator (2C to 8C [36F to 46F]) until needed for use.
• Before dilution: Equilibrate to room temperature (20C to 25C [68F to 77F]); can store sealed vials up to 12 hours at room temperature before dilution
• Lyophilized Powder: Store vials below 30C (86F) until needed for use.
• After reconstitution: Use vial immediately to prepare diluted solution.
• Diluted Solution in the Infusion Bags: Can store up to 24 hours at room temperature (20C to 25C [68F to 77F]) or 48 hours refrigerated (2C to 8C [36F to 46F]) before administration
• Diluted Solution in Syringe: Should be used immediately

• The 2 formulations have differences in preparation; the manufacturer product information should be consulted, and the product-specific instructions should be followed carefully.
• Injection Solution: Must be diluted before IV infusion
• Lyophilized Powder: Must be reconstituted and further diluted before IV infusion
• Dilute within the same day as administration.

• Compatible (injection solution): 0.9% sodium chloride injection, USP
• Compatible (lyophilized powder): Sterile Water for Injection; 0.9% sodium chloride injection, USP
• Compatibility with other IV solutions and medications is not known.

• There are 2 different formulations of this drug, supplied as lyophilized powder in vial and as solution in vial; the manufacturer product information should be consulted.
• The lyophilized powder formulation is the only approved dosage form for pediatric patients weighing 3 to less than 40 kg.

• Hematologic: Prothrombin time in all patients (before starting and during therapy as clinically appropriate)
• Hepatic: Hepatic laboratory testing in all patients (before starting and during therapy as clinically appropriate)
• Hypersensitivity: For sign/symptoms of hypersensitivity (during and after infusion as clinically appropriate)
• Renal: Estimated GFR in all patients (before starting and during therapy as clinically appropriate)

• Read the US FDA-approved patient labeling (Patient Information).
• Notify health care provider if any of the following occur: changes in heart rate, fever, shortness of breath/wheezing, swelling of lips/face/throat, rash, nausea, sweating, or shivering.
• Notify health care provider immediately if any symptoms of liver inflammation develop.
• Patients of childbearing potential: Inform health care provider of pregnancy.

Frequently asked questions

• Can Remdesivir be used to treat COVID-19 (coronavirus)?