SUMMARY

• TREMFYA solution for intravenous (IV) infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique as an induction therapy for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). It is to be administered over at least 1 hour according to the DOSAGE AND ADMINISTRATION section of the TREMFYA full Prescribing Information.¹
• The rate of infusion can be calculated using total infusion volume (in mL) and total infusion time (in minutes): Infusion rate (mL/minute)= total infusion volume
  (in mL)/total infusion time (in minutes).

PRESCRIBING INFORMATION

2 DOSAGE AND ADMINISTRATION

2.6 Preparation and Administration Instructions for Intravenous Infusion (Ulcerative Colitis)

Preparation Instructions

1. Withdraw and then discard 20 mL of the 0.9% Sodium Chloride Injection from the 250 mL infusion bag which is equal to the volume of TREMFYA to be added.¹
2. Withdraw 20 mL of TREMFYA from the vial and add it to the 250 mL IV infusion bag of 0.9% Sodium Chloride Injection for a final concentration of 0.8 mg/mL. Gently mix the diluted solution. Discard the vial with any remaining solution.¹
3. Visually inspect the diluted solution for particulate matter and discoloration before infusion. Infuse the diluted solution over a period of at least one hour.¹
4. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein binding filter (pore size 0.2 micrometer).¹
5. Do not infuse TREMFYA concomitantly in the same IV line with other medicinal products.¹
6. Dispose any unused medicinal product in accordance with local requirements.¹

Administration Instructions

• TREMFYA solution for IV infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. TREMFYA does not contain preservatives. Each vial is for one time use in one patient only.¹
• Inspect TREMFYA visually for particulate matter and discoloration prior to administration. TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. Do not use if the liquid contains large particles, is discolored, or is cloudy.¹