SUMMARY  

• Please refer to the TREMFYA Prescribing Information for information on how to prepare and administer TREMFYA for intravenous (IV) infusion.
• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling. Off-label data are available for situations outside of recommended dilution requirements.
• The information described below is specific to preparation of TREMFYA for intravenous infusion using two TREMFYA 100 mg/mL prefilled syringes (PFS) in dextrose 5% in water for injection (D5W) during an open-label bioequivalence study of the TREMFYA IV formulation using PFS. This preparation information is similar to that used in the phase 2b/3 study of TREMFYA in adults with moderately to severely active ulcerative colitis (UC).
• Specific steps are described below:¹
  • Remove two PFS from the refrigerator and allow them to reach room temperature (45 ± 15 minutes) without removing the needle cap.
  • Obtain one 100 mL 5% Dextrose Injection (D5W) container.
  • Visually inspect each TREMFYA PFS for particulate matter or discoloration prior to dose preparation. The TREMFYA solution in the PFS should be 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 cloudy.
  • Orient the D5W infusion container, slowly inject TREMFYA solution from the PFS into the D5W infusion container so that the needle tip is submerged in the D5W infusion solution.
  • Repeat step 4 with the second PFS to transfer a total of 2 mL (200 mg) into the D5W infusion container.
  • Gently invert the infusion container slowly at least 5 times. Do not shake.
  • Visually inspect the content of the 100 mL D5W infusion container for particulate matter. Solution in the D5W infusion container should be colorless to light yellow and clear. A few small translucent or fine particles that are white or clear may be present and are considered normal. Do not use if visibly opaque particles, discoloration, or foreign particles are observed.
• The infusion must be completed within 6 hours (from the first PFS transfer into infusion container to completion of administration) using a 0.2 micrometer polyethersulfone (PES) or polysulfone (PSF) low protein-binding in-line filter.
• Do not freeze or refrigerate the prepared infusion container.