Mirikizumab for IV infusion is supplied as a 300 mg/15 mL (20 mg/mL) solution in a single-dose vial.1

Mirikizumab is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution.1

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles. Do not use mirikizumab if it is cloudy or there are visible particles.1

Using an 18- to 21-gauge needle, withdraw 15 mL of mirikizumab solution from the vial and transfer to an infusion bag ranging in size from 50 mL to 250 mL of

• 0.9% Sodium Chloride Injection, or
• 5% Dextrose Injection.1

Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with other solutions.1

Gently invert the infusion bag to mix the contents. Do not shake the prepared infusion bag.1

Connect the intravenous administration set (infusion line) to the prepared infusion bag and prime the line.1

Mirikizumab IV infusion occurs over at least 30 minutes. Patients should be monitored for at least 1 hour after dosing, according to the local standard of care.1,2

At the end of the infusion, flush the line with

• 0.9% Sodium Chloride Injection, or
• 5% Dextrose Injection.1

Administer the flush at the same infusion rate as used for mirikizumab administration.1

The time required to flush mirikizumab solution from the infusion line is in addition to the minimum 30‑minute infusion time.1

Store mirikizumab refrigerated at 36°F to 46°F (2°C-8°C). Do not freeze and do not use mirikizumab if it has been frozen.1

Keep mirikizumab in the original carton to protect from light until time of use.1

Keep the drug product away from direct heat or light.1

Start the infusion immediately after preparation. If not used immediately, store the diluted infusion solution in the refrigerator at 36°F to 46°F (2°C-8°C). Use the diluted infusion solution within 48 total hours, of which not more than 5 hours are permitted at nonrefrigerated temperatures not to exceed 77°F (25°C), starting from the time of vial puncture.1

Keep the drug product away from direct heat or light.1

Do not freeze the diluted solution in the prepared infusion bag.1