WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

MENINGOCOCCAL INFECTIONS MAY OCCUR IN PATIENTS TREATED WITH PEGCETACOPLAN AND MAY BECOME RAPIDLY LIFE-THREATENING OR FATAL IF NOT RECOGNIZED AND TREATED EARLY. USE OF PEGCETACOPLAN MAY PREDISPOSE INDIVIDUALS TO SERIOUS INFECTIONS, ESPECIALLY THOSE CAUSED BY ENCAPSULATED BACTERIA, SUCH AS STREPTOCOCCUS PNEUMONIAE, NEISSERIA MENINGITIDIS TYPES A, C, W, Y, AND B, AND HAEMOPHILUS INFLUENZAE TYPE B.

• COMPLY WITH THE MOST CURRENT ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) RECOMMENDATIONS FOR VACCINATIONS AGAINST ENCAPSULATED BACTERIA.

• VACCINATE PATIENTS AGAINST ENCAPSULATED BACTERIA AS RECOMMENDED AT LEAST 2 WEEKS PRIOR TO ADMINISTERING THE FIRST DOSE OF PEGCETACOPLAN UNLESS THE RISKS OF DELAYING PEGCETACOPLAN THERAPY OUTWEIGH THE RISKS OF DEVELOPING A SERIOUS INFECTION.

• VACCINATION REDUCES, BUT DOES NOT ELIMINATE, THE RISK OF SERIOUS INFECTIONS. MONITOR PATIENTS FOR EARLY SIGNS OF SERIOUS INFECTIONS AND EVALUATE IMMEDIATELY IF INFECTION IS SUSPECTED.

PEGCETACOPLAN IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK EVALUATION AND MITIGATION STRATEGY (REMS). UNDER THE PEGCETACOPLAN REMS, PRESCRIBERS MUST ENROLL IN THE PROGRAM.