CD55-deficient protein-losing enteropathy

Recommended vaccination and prophylaxis for meningococcal infection prior to first dose of pozelimab

• Vaccinate patients for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current ACIP recommendations for patients receiving a complement inhibitor at least 2 weeks prior to administering the first dose of pozelimab.
• If urgent pozelimab therapy is indicated in a patient who is not up-to-date with vaccines for both MenACWY and MenB according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis. The efficacy, duration, and drug regimens for antibacterial drug prophylaxis have not been studied in patients receiving complement inhibitors, including pozelimab.

Recommended dosage and administration

The recommended dosage of pozelimab is as follows:

Day 1 (Loading Dose):

Administer a single 30 mg/kg dose by intravenous infusion after dilution.

Day 8 and Thereafter (Maintenance Dosage):

Inject 10 mg/kg as a subcutaneous injection once weekly starting on Day 8.

• The maintenance dosage may be increased to 12 mg/kg once weekly if there is inadequate clinical response after at least 3 weekly doses (i.e., starting from Week 4).
• The maximum maintenance dosage is 800 mg once weekly.

Recommendations regarding missed maintenance subcutaneous dose(s)

If a subcutaneous maintenance dose of pozelimab is missed, administer as soon as possible within 3 days after the missed dose. Do not administer 2 doses on the same day to make up for a missed dose. If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 4 days (96 hours).