Remidia Dosage/Direction for Use

This section provides essential information on the use of Remdesivir for the treatment of laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) patients hospitalized with severe disease. Severe disease is 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).
Please refer to this fact sheet for information on use of Remdesivir under the EUA.
DOSING: Use of Remdesivir is confined to healthcare facilities in which patients can be monitored closely.
The recommended dosage of Remdesivir in patients 12 years of age and older and weighing at least 40 kg is: Day 1 - single loading dose of Remdesivir 200 mg given by intravenous infusion; Day 2 onwards - 100 mg given once daily by intravenous infusion.
The total duration of treatment should be at least 5 days and not more than 10 days.
Special populations: Elderly: No dose adjustment of Remdesivir is required in patients over the age of 65 years.
Renal impairment: The pharmacokinetics of Remdesivir have not been evaluated in patients with renal impairment. Patients with eGFR ≥30 mL/min have received Remdesivir for treatment of COVID-19 with no dose adjustment. Remdesivir should not be used in patients with eGFR <30 mL/minute.
Hepatic impairment: The pharmacokinetics of Remdesivir have not been evaluated in patients with hepatic impairment. It is not known if dosage adjustment is appropriate in patients with hepatic impairment.
Pediatric population: The safety and efficacy of Remdesivir in children under the age of 12 years and weighing < 40 kg have not yet been established. No data are available.
Method of administration: For intravenous use.
Remdesivir is for administration by intravenous infusion after reconstitution and further dilution. It must not be given as an intramuscular (IM) injection.
For instructions on reconstitution and dilution of the medicinal product before administration, see as follows: (See Table 2.)


Click on icon to see table/diagram/image


Prepare solution for infusion under aseptic conditions and on the same day as administration. Remdesivir should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.
Remdesivir must be reconstituted with 19 mL sterile water for injections and diluted in sodium chloride 9 mg/mL (0.9%) solution for injection before being administered via intravenous infusion over 30 to 120 minutes.
Preparation of Remdesivir solution for infusion: Reconstitution: Remove the required number of single-use vial(s) from storage. For each vial: Aseptically reconstitute Remdesivir lyophilized powder injection by addition of 19 mL of sterile water for injections using a suitably sized syringe and needle per vial.
Discard the vial if a vacuum does not pull the sterile water for injections into the vial.
Immediately shake the vial for 30 seconds.
Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
If the contents of the vial are not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
Inspect the vial to ensure the container closure is free from defects and the solution is free of particulate matter.
Dilute immediately after reconstitution.
Dilution: Care should be taken to prevent inadvertent microbial contamination. As there is no preservative or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the final parenteral solution. It is always recommended to administer IV medicines immediately after preparation when possible.
Using Table 3 as follows, determine the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to withdraw from the infusion bag. (See Table 3.)


Click on icon to see table/diagram/image


Note: 100 mL should be reserved for patients with severe fluid restriction, e.g. with ARDS or renal failure.
Withdraw and discard the required volume of sodium chloride 9 mg/mL from the bag using an appropriately sized syringe and needle per Table 3.
Withdraw the required volume of reconstituted Remdesivir lyophilized powder injection using an appropriately sized syringe per Table 3. Discard any unused portion remaining in the Remdesivir vial.
Transfer the required volume of reconstituted Remdesivir lyophilized powder injection to the selected infusion bag.
Gently invert the bag 20 times to mix the solution in the bag. Do not shake.
The prepared solution is stable for 4 hours at room temperature (20°C to 25°C) or 24 hours in the refrigerator (2°C to 8°C) (including any time before dilution into intravenous infusion fluid).
After infusion is complete, flush with at least 30 mL of sodium chloride 9 mg/mL.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
IMPORTANT: This product contains no preservative. Any unused portion of a single-dose Remdesivir vial should be discarded after a diluted solution is prepared.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Should either be observed, the solution should be discarded and fresh solution prepared.
The prepared diluted solution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than 0.9% saline is not known.