Veklury Dosage

Generic name: REMDESIVIR 5mg in 1mL
Dosage form: injection
Drug class: Purine nucleosides

Medically reviewed by Drugs.com. Last updated on Mar 6, 2024.

Dosage and Administration Overview

VEKLURY may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Dosage and Administration (2.5, 2.6), Warnings and Precautions (5.1)].
Administer VEKLURY for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) by intravenous infusion only. Do not administer by any other route.
There are TWO different formulations of VEKLURY:
- VEKLURY for injection (supplied as 100 mg lyophilized powder in vial) must be reconstituted with Sterile Water for Injection prior to diluting with 0.9% sodium chloride injection.
  - The only approved dosage form of VEKLURY for pediatric patients weighing 1.5 kg to less than 40 kg is VEKLURY for injection (supplied as 100 mg lyophilized powder in vial).
- VEKLURY injection (supplied as 100 mg/20 mL [5 mg/mL] solution in vial) must be further diluted in 250 mL of 0.9% sodium chloride injection infusion bag.
There are differences in the way the two formulations are prepared. Carefully follow the product-specific preparation instructions below [see Dosage and Administration (2.5, 2.6)].

Testing Before Starting and During Treatment with VEKLURY

Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7)].

Determine prothrombin time in all patients before starting VEKLURY and monitor while receiving VEKLURY as clinically appropriate [see Adverse Reactions (6.1)].

Recommended Dosage in Adults and Pediatric Patients (Birth to Less than 18 Years of Age Weighing at Least 1.5 kg)

The recommended dosage for adults and pediatric patients weighing at least 40 kg is a single loading dose of VEKLURY 200 mg on Day 1 via intravenous infusion followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion.
The recommended dosage for pediatric patients weighing 1.5 kg to less than 40 kg is presented in Table 1.

Table 1 Recommended Dosage in Pediatric Patients Including Term* Neonates and Infants Weighing 1.5 kg to Less than 40 kg
Pediatric Patient Population	Loading Dose Via Intravenous Infusion	Maintenance Dose Via Intravenous Infusion
* Gestational age greater than 37 weeks.
Less than 28 days old and at least 1.5 kg	VEKLURY 2.5 mg/kg on Day 1	VEKLURY 1.25 mg/kg once daily from Day 2
At least 28 days old and 1.5 kg to less than 3 kg	VEKLURY 2.5 mg/kg on Day 1	VEKLURY 1.25 mg/kg once daily from Day 2
At least 28 days old and 3 kg to less than 40 kg	VEKLURY 5 mg/kg on Day 1	VEKLURY 2.5 mg/kg once daily from Day 2

The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made.

The recommended total treatment duration for hospitalized patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) is 10 days.
The recommended treatment duration for hospitalized patients not requiring invasive mechanical ventilation and/or ECMO is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.

Non-hospitalized patients:

The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset.

The recommended total treatment duration for non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, is 3 days.

VEKLURY must be diluted prior to intravenous infusion. Refer to Dosage and Administration (2.5, 2.6) for detailed preparation and administration instructions.

Renal Impairment

No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including patients on dialysis. VEKLURY may be administered without regard to the timing of dialysis [see Dosage and Administration (2.3) and Use in Specific Populations (8.4, 8.6)].

Dosage Preparation and Administration in Adults and Pediatric Patients Weighing at Least 40 kg

There are differences in the way the two formulations are prepared. Carefully follow the product-specific preparation instructions below.

VEKLURY for Injection (Supplied as 100 mg Lyophilized Powder in Vial)

Reconstitution Instructions

Remove the required number of single-dose vial(s) from storage. For each vial:

Aseptically reconstitute VEKLURY lyophilized powder by adding 19 mL of Sterile Water for Injection using a suitably sized syringe and needle per vial, and insert the needle in the center of the vial stopper.
Only use Sterile Water for Injection to reconstitute VEKLURY lyophilized powder.
Discard the vial if a vacuum does not pull the Sterile Water for Injection 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, colorless to yellow solution, free of visible particles, 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. Discard the vial if the contents are not completely dissolved.
Following reconstitution, each vial contains 100 mg/20 mL (5 mg/mL) of remdesivir solution.
Use reconstituted product immediately to prepare the diluted drug product [see Dosage and Administration (2.7)].

Dilution Instructions

Care should be taken during admixture 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 intravenous medication immediately after preparation when possible.

Reconstituted VEKLURY for injection, containing 100 mg/20 mL remdesivir solution, must be further diluted in either a 100 mL or 250 mL 0.9% sodium chloride injection infusion bag. Refer to Table 2 for instructions.

Table 2 Recommended Dilution Instructions—Reconstituted VEKLURY for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing at Least 40 kg
VEKLURY dose	0.9% sodium chloride injection infusion bag volume to be used	Volume to be withdrawn and discarded from 0.9% sodium chloride injection infusion bag	Required volume of reconstituted VEKLURY for injection
Loading dose 200 mg (2 vials)	250 mL	40 mL	40 mL (2 × 20 mL)
Loading dose 200 mg (2 vials)	100 mL	40 mL	40 mL (2 × 20 mL)
Maintenance dose 100 mg (1 vial)	250 mL	20 mL	20 mL
Maintenance dose 100 mg (1 vial)	100 mL	20 mL	20 mL

Withdraw and discard the required volume of 0.9% sodium chloride injection from the bag following instructions in Table 2, using an appropriately sized syringe and needle.
Withdraw the required volume of reconstituted VEKLURY for injection from the VEKLURY vial following instructions in Table 2, using an appropriately sized syringe. Discard any unused portion remaining in the reconstituted vial.
Transfer the required volume of reconstituted VEKLURY for injection to the selected infusion bag.
Gently invert the bag 20 times to mix the solution in the bag. Do not shake.
The prepared infusion solution can be stored for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) prior to administration.

Administration Instructions

Do not administer the prepared diluted solution simultaneously with any other medication. The compatibility of VEKLURY injection with intravenous solutions and medications other than 0.9% sodium chloride injection, USP is not known. Administer VEKLURY via intravenous infusion over 30 to 120 minutes.

Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate [see Warnings and Precautions (5.1)].

Administer the diluted solution with the infusion rate described in Table 3.

Table 3 Recommended Rate of Infusion—Diluted VEKLURY for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing at Least 40 kg
Infusion bag volume	Infusion time	Rate of infusion
250 mL	30 min	8.33 mL/min
	60 min	4.17 mL/min
	120 min	2.08 mL/min
100 mL	30 min	3.33 mL/min
	60 min	1.67 mL/min
	120 min	0.83 mL/min

VEKLURY Injection (Supplied as 100 mg/20 mL [5 mg/mL] Solution in Vial)

Dilution Instructions

Remove the required number of single-dose vial(s) from storage. Each vial contains 100 mg/20 mL of remdesivir. For each vial:
Equilibrate to room temperature (20°C to 25°C [68°F to 77°F]). Sealed vials can be stored up to 12 hours at room temperature prior to dilution.
Inspect the vial to ensure the container closure is free from defects and the solution is free of particulate matter.
VEKLURY injection must be diluted in an infusion bag containing 250 mL of 0.9% sodium chloride injection only. Refer to Table 4 for instructions.

Table 4 Recommended Dilution Instructions—VEKLURY Injection (Supplied as Solution in Vial) in Adults and Pediatric Patients Weighing at Least 40 kg
VEKLURY dose	0.9% sodium chloride injection infusion bag volume to be used	Volume to be withdrawn and discarded from 0.9% sodium chloride injection infusion bag	Required volume of VEKLURY injection
Loading dose 200 mg (2 vials)	250 mL	40 mL	40 mL (2 × 20 mL)
Maintenance dose 100 mg (1 vial)	250 mL	20 mL	20 mL

Withdraw and discard the required volume of 0.9% sodium chloride injection from the bag following instructions in Table 4, using an appropriately sized syringe and needle.
Withdraw the required volume of VEKLURY injection from the VEKLURY vial following instructions in Table 4, using an appropriately sized syringe.
Pull the syringe plunger rod back to fill the syringe with approximately 10 mL of air.
Inject the air into the VEKLURY injection vial above the level of the solution.
Invert the vial and withdraw the required volume of VEKLURY injection solution into the syringe. The last 5 mL of solution requires more force to withdraw.
Transfer the required volume of VEKLURY injection to the infusion bag.
Gently invert the bag 20 times to mix the solution in the bag. Do not shake.
The prepared infusion solution is stable for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Administration Instructions

Administer the diluted solution with the infusion rate described in Table 5.

Table 5 Recommended Rate of Infusion—Diluted VEKLURY Injection Solution in Adults and Pediatric Patients Weighing at Least 40 kg
Infusion bag volume	Infusion time	Rate of infusion
250 mL	30 min	8.33 mL/min
	60 min	4.17 mL/min
	120 min	2.08 mL/min

Dosage Preparation and Administration in Pediatric Patients (Birth to Less than 18 Years of Age) Weighing 1.5 kg to Less than 40 kg

The only approved dosage form of VEKLURY for pediatric patients weighing 1.5 kg to less than 40 kg is VEKLURY for injection (supplied as 100 mg lyophilized powder in vial). Carefully follow the product-specific preparation instructions below.

Use VEKLURY for Injection (Supplied as 100 mg Lyophilized Powder in Vial) only.

Reconstitution Instructions

Remove the required number of single-dose vial(s) from storage. For each vial:

Aseptically reconstitute VEKLURY lyophilized powder by adding 19 mL of Sterile Water for Injection using a suitably sized syringe and needle per vial.
Only use Sterile Water for Injection to reconstitute VEKLURY lyophilized powder.
Discard the vial if a vacuum does not pull the Sterile Water for Injection 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, colorless to yellow solution, free of visible particles, 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. Discard the vial if the contents are not completely dissolved.
Following reconstitution, each vial contains 100 mg/20 mL (5 mg/mL) of remdesivir solution.
Use reconstituted product immediately to prepare the diluted drug product [see Dosage and Administration (2.7)].

Dilution Instructions

For pediatric patients (birth to less than 18 years of age) weighing 1.5 kg to less than 40 kg, the 100 mg/20 mL (5 mg/mL) remdesivir reconstituted solution should be further diluted to a fixed concentration of 1.25 mg/mL using 0.9% sodium chloride injection.
The final required infusion volume concentration of 1.25 mg/mL remdesivir diluted solution for infusion is based on the pediatric weight-based dosing regimens.
Small 0.9% sodium chloride injection infusion bags (e.g., 25, 50, or 100 mL) or an appropriately sized syringe should be used for pediatric dosing. The recommended dose is administered via intravenous infusion in a total volume dependent on the dose to yield the target remdesivir concentration of 1.25 mg/mL.
A syringe and syringe pump may be used for infusion volumes less than 50 mL.

Infusion with IV Bag

Determine the total infusion volume needed to achieve a final infusion volume concentration of 1.25 mg/mL of remdesivir diluted solution based on the patient's calculated dose.
Select an appropriately sized infusion bag (either prefilled with 0.9% sodium chloride injection or empty) to prepare VEKLURY diluted solution.
If using a prefilled 0.9% sodium chloride injection infusion bag, withdraw and discard the amount of diluent equal to the volume of reconstituted VEKLURY solution needed per patient's dose plus a quantity sufficient to achieve a 1.25 mg/mL final volume concentration of remdesivir diluted solution.
Withdraw the required volume of reconstituted VEKLURY solution into an appropriately sized syringe.
Transfer the required volume of reconstituted VEKLURY solution to the 0.9% sodium chloride injection infusion bag.
Gently invert the bag 20 times to mix the solution in the bag. Do not shake.
If using an empty infusion bag, transfer the required volume of reconstituted VEKLURY solution to the bag, followed by a volume of 0.9% sodium chloride injection sufficient to achieve a 1.25 mg/mL final volume concentration of remdesivir diluted solution.
The prepared infusion solution is stable for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Infusion with Syringe

Determine the total infusion volume needed to achieve a final infusion volume concentration of 1.25 mg/mL of remdesivir diluted solution based on patient's calculated dose.
Select an appropriately sized syringe equal to or larger than the calculated total infusion volume of 1.25 mg/mL remdesivir solution needed.
Withdraw the required volume of reconstituted VEKLURY solution from the vial into the syringe based on patient's calculated dose, followed by the required volume of 0.9% sodium chloride injection needed to achieve a 1.25 mg/mL final volume concentration of remdesivir diluted solution.
Gently invert the syringe 20 times to mix the solution in the syringe. Do not shake.
The prepared diluted solution should be used immediately.

Administration Instructions

The prepared diluted solution should not be administered simultaneously with any other medication. The compatibility of VEKLURY with IV solutions and medications other than 0.9% sodium chloride injection, USP is not known. Administer VEKLURY via intravenous infusion over 30 to 120 minutes. The rate of infusion (mL/min) should be calculated based on the total infusion volume and total infusion time.

Storage of Prepared Dosages

VEKLURY for Injection (Supplied as Lyophilized Powder in Vial)

After reconstitution, use vials immediately to prepare diluted solution. The diluted VEKLURY solution in the infusion bags can be stored up to 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) prior to administration or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

VEKLURY Injection (Supplied as Solution in Vial)

Store VEKLURY injection after dilution in the infusion bags up to 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

IMPORTANT:

This product contains no preservative. Any unused portion of a single-dose VEKLURY vial should be discarded after a diluted solution is prepared.