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Remdesivir Dosage

Medically reviewed by Drugs.com. Last updated on Nov 20, 2020.

Applies to the following strengths: 100 mg; 5 mg/mL

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

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:
-Invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) required: 10 days total
-Invasive mechanical ventilation and/or ECMO not required: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown

Comments:
-This drug should only be administered in a hospital or in a healthcare setting that can provide acute care comparable to inpatient hospital care.

Use: For the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization

Usual Pediatric Dose for COVID-19

12 years or older weighing at least 40 kg:
-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:
-Invasive mechanical ventilation and/or ECMO required: 10 days total
-Invasive mechanical ventilation and/or ECMO not required: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown

Comments:
-This drug should only be administered in a hospital or in a healthcare setting that can provide acute care comparable to inpatient hospital care.

Use: For the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization

FOR INVESTIGATIONAL USE ONLY

Weight 3.5 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

Less than 12 years weighing at least 40 kg:
-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:
-Invasive mechanical ventilation and/or ECMO required: 10 days total
-Invasive mechanical ventilation and/or ECMO not required: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown

Comments:
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this drug for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-Pediatric patients (older than 28 days) must have estimated glomerular filtration rate (eGFR) determined and full-term neonates (7 to 28 days old) must have serum creatinine determined before starting this drug and during therapy as clinically appropriate.
-Hepatic laboratory testing should be performed in all patients before starting this drug and during therapy as clinically appropriate.
-Prothrombin time should be determined in all patients before starting this drug and should be monitored during therapy as clinically appropriate.
-The lyophilized powder formulation is the only authorized dosage form for pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-Empiric treatment of hospitalized patients with suspected COVID-19 can be considered pending laboratory confirmation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
-This drug can be used at any time after onset of symptoms in hospitalized patients.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the treatment of hospitalized pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate

Renal Dose Adjustments

Adult and pediatric patients (12 years or older weighing at least 40 kg):
-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 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.

FOR INVESTIGATIONAL USE ONLY

Full-term neonates (7 to 28 days old):
-Serum creatinine at least 1 mg/dL: Not recommended.

Pediatric patients (older than 28 days):
-Estimated GFR less than 30 mL/min: Not recommended.

Comments:
-Pediatric patients (older than 28 days) must have eGFR determined and full-term neonates (7 to 28 days old) must have serum creatinine determined before dosing and while receiving this drug.
-Renal function of pediatric patients should be monitored; if renal function declines substantially, discontinuation of therapy should be considered.

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.

Comments:
-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

US BOXED WARNINGS (ASSOCIATED WITH EUA):
-This EUA is for the use of Veklury (remdesivir) to treat COVID-19 in hospitalized pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-This drug must be administered by IV infusion (over 30 to 120 minutes).
-Healthcare providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to this drug; the Fact Sheet for Healthcare Providers should be consulted regarding reporting requirements.
-The lyophilized powder formulation is the only authorized dosage form for pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

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

Safety and efficacy have not been established in patients younger than 12 years or weighing less than 40 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 by IV infusion only; do not administer by any other route.
-Infuse IV over 30 to 120 minutes; consult the manufacturer product information (or EUA Fact Sheet for Healthcare Providers) for recommended infusion rates.
-Do not administer the prepared diluted solution simultaneously with any other medication.

Storage requirements:
-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: Store up to 24 hours at room temperature (20C to 25C [68F to 77F]) or 48 hours refrigerated (2C to 8C [36F to 46F]).

Reconstitution/preparation techniques:
-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.
-The manufacturer product information should be consulted.

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

Monitoring:
-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)
-Renal: Estimated GFR in all patients (before starting and during therapy as clinically appropriate); per EUA: Estimated GFR in pediatric patients older than 28 days and serum creatinine in full-term neonates 7 to 28 days old (before starting and during therapy as clinically appropriate)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Notify healthcare 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 healthcare provider immediately if any symptoms of liver inflammation develop.
-Patients of childbearing potential: Inform healthcare provider immediately of pregnancy.
-For hospitalized pediatric patients weighing 3.5 to less than 40 kg or hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg: Read the Fact Sheet for Patients and Parents/Caregivers.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.