Preparation

• Use aseptic technique to prepare the solution for infusion.
• Draw and discard 15 mL from a 100 mL container of sterile 0.9% Sodium Chloride Injection.
• Slowly replace with 15 mL of SPEVIGO (complete content from two vials of 450 mg/7.5 mL).
• Mix gently before use.
• Use the diluted SPEVIGO solution immediately.

Administration

• Do not mix SPEVIGO with other medicinal products.
• Administer SPEVIGO as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes.
• If the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes [see Warnings and Precautions (5.3)].
• A pre-existing intravenous line may be used for administration of SPEVIGO. The line must be flushed with sterile 0.9% Sodium Chloride Injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
• No incompatibilities have been observed between SPEVIGO and infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).

Storage of Diluted Solution

If not administered immediately, refrigerate the diluted solution at 2°C to 8°C (36°F to 46°F) for no more than 4 hours. Protect from light.