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

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 1 for instructions.

• Withdraw and discard the required volume of 0.9% sodium chloride injection from the bag following instructions in Table 1, using an appropriately sized syringe and needle.
• Withdraw the required volume of reconstituted VEKLURY for injection from the VEKLURY vial following instructions in Table 1, 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 2.

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.

• 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 3 for instructions.

• Withdraw and discard the required volume of 0.9% sodium chloride injection from the bag following instructions in Table 3, using an appropriately sized syringe and needle.
• Withdraw the required volume of VEKLURY injection from the VEKLURY vial following instructions in Table 3, 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

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 4.

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.