Alternate Name(s):
Veklury®
Classification:
Nucleotide Prodrug
Original Date:
January 2023
Indications:
For the treatment of suspected or laboratory confirmed COVID-19 in pediatric patients hospitalized with severe disease, defined as patients with an oxygen saturation (SpO2) ≤94% on room air, or requiring supplemental oxygen, or requiring mechanical ventilation, or requiring extracorporeal membrane oxygenation (ECMO).
Reconstitution and Stability:
| Product | Dose per vial | Vial Size | Volume of SWFI | Total Volume | Final Concentration |
| Solution for Injection | 100 mg | 20 mL | N/A - comes as solution | 20 mL | 5 mg/mL |
| Lyophilized Powder | 100 mg | 20 mL | 19 mL | 20 mL | 5 mg/mL |
There are two products available:
- Remdesivir 100 mg/20 mL solution for injection:
- Not to be used for pediatric patients weighing less than 40 kg due to higher amounts of sulfobutylether-B-cyclodextrin sodium salt (SBECD) resulting in higher tonicity of the solution than the lyophilized formulation.
- All doses to be prepared in an exact volume bag of 0.9% sodium chloride to a total volume of 250 mL.
- Store vials in original carton refrigerated (2 – 8ᵒC). DO NOT FREEZE. DO NOT SHAKE.
- Remdesivir 100 mg/vial lyophilized powder:
- This product can be used at any age/weight, and must be reconstituted prior to use.
- Once lyophilized powder vial is reconstituted, the product should be diluted and administered immediately. If necessary, diluted solutions can be stored prior to administration for a time not to exceed 4 hours at room temperature (20-25°C) or 24 hours refrigerated (2 – 8°C).
- For patients ≥40 kg: All doses to be prepared in an exact volume bag of 0.9% sodium chloride to a total volume of 100 mL or 250 mL.
- For patients 3.5 kg to <40 kg: All does to be prepared in an exact volume bag or syringe of 0.9% sodium chloride to a concentration of 1 mg/mL.
- Store vials in original carton below 30ᵒC. DO NOT FREEZE. DO NOT SHAKE.
- All products are preservative-free and therefore are single-use vials.
- Once diluted in 0.9% sodium chloride, dose should be administered immediately. However, if necessary, prepared solutions can be stored up to 4 hours at room temperature (20-25°C) or 24 hours refrigerated (2 – 8°C).
- Do not use if solution has discoloration, opaque particles or any foreign material observed.
Compatibility:
- Solutions compatible: 0.9% Sodium Chloride
- Additives/Above Cassette Compatible: Unknown
- Y-Site compatibility: Unknown
- Incompatible: DO NOT infuse with any other medication or solution
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES Infusion time: 30 to 120 minutes, flush line with ≥30 mL 0.9% NaCl after infusion Usual concentration for pediatric patients: 1 mg/mL |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Hepatic function testing should be carried out for all patients prior to initiation of remdesivir and monitored during therapy.
- Therapy should not be started in patients with ALT ≥5x the ULN
- Therapy should be discontinued in patients who’s ALT increases to ≥5x the ULN (restarting therapy can be considered when ALT is less than 5x the ULN), OR the rise in ALT is accompanied by liver inflammation, or increasing conjugated bilirubin, alkaline phosphatase or INR.
- Use with caution in renal impairment if CrCl < 30 ml/min, however significant toxicity with a short duration of therapy (eg, 5 to 10 days) is unlikely; benefits may outweigh the risks in select patients
| Body Weight (kg) | Induction Dose on Day 1 | Maintenance Dose |
| 3.5kg to <40kg* | 5 mg/kg/dose (max 200mg) | 2.5mg/kg/dose (max 100mg) |
|
≥40 kg |
200mg | 100mg |
*lyophilized powder for injection only
Duration of Therapy:
- Patients requiring invasive mechanical ventilation and/or ECMO – 10 days of treatment
- Patients not requiring invasive mechanical ventilation and/or ECMO – 5 days of treatment. If no clinical improvement within 5 days, treatment can be extended up to 5 additional days.
Potential hazards of parenteral administration:
- Monitor for hypersensitivity reactions, including infusion-related and anaphylactic reactions (hypotension, tachycardia, bradycardia, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis). Infusion time can be increased to a maximum of 120 minutes to potentially prevent this
Notes:
- Avoid co-administration with chloroquine phosphate or hydroxychloroquine sulphate due to antagonistic effect of chloroquine on activation and antiviral activity of remdesivir.
- Remdesivir was shown in vitro to be an inhibitor of CYP3A4 and OATP 1B1/1B3, so substrates of these enzymes should be administered at least two hours after remdesivir.
- Remdesivir was shown in vitro to be an inducer of CYP1A2 and CYP3A4, so substrates of these enzymes that have a narrow therapeutic index may require dose modifications and more frequent monitoring.
References:
- Emergency Use Authorization (EUA) Factsheet of Veklury (remdesivir), Gilead Sciences Inc. July 2020
- VEKLURY Product Monograph, Gilead Sciences Canada Inc. July 2020
- Ontario COVID-19 Clinical Practice Guidelines, Dosing and Pharmacologic Considerations for Medications Under Investigation Against COVID-19, September 3, 2020