ering the duration of ULTOMIRIS therapy.
Immunize patients without a history of meningococcal vaccination at least 2 weeks priorto receiving the first dose of ULTOMIRIS. If urgent ULTOMIRIS therapy is indicated inan unvaccinated patient, administer meningococcal vaccine(s) as soon as possible andprovide patients with 2 weeks of antibacterial drug prophylaxis.
In clinical studies, 59 patients with PNH were treated with ULTOMIRIS less than2 weeks after meningococcal vaccination. All of these patients received antibiotics for
prophylaxis of meningococcal infection until at least 2 weeks after meningococcalvaccination. The benefits and risks of antibiotic prophylaxis for prevention of
meningococcal infections in patients receiving ULTOMIRIS have not been established.
Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Inclinical studies, 3 out of 261 PNH patients developed serious meningococcal
infections/sepsis while receiving treatment with ULTOMIRIS; all 3 had been vaccinated.
These 3 patients recovered while continuing treatment with ULTOMIRIS.
Closely monitor patients for early signs and symptoms of meningococcal infection andeva luate patients immediately if infection is suspected. Inform patients of these signs andsymptoms and steps to be taken to seek immediate medical care. Meningococcalinfection may become rapidly life-threatening or fatal if not recognized and treated early.
Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment forserious meningococcal infection.
REMS
Due to the risk of meningococcal infections, ULTOMIRIS is available only through arestricted program under a Risk eva luation and Mitigation Strategy (REMS). Under the
ULTOMIRIS REMS, prescribers must enroll in the program.
Prescribers must counsel patients about the risk of meningococcal infection/sepsis,provide the patients with the REMS educational materials, and ensure patients are
vaccinated with meningococcal vaccines.
Enrollment in the ULTOMIRIS REMS and additional information are available bytelephone: 1-888-765-4747 or at www.ultomirisrems.com.
5.2 Other Infections
ULTOMIRIS blocks terminal complement activation; therefore, patients may haveincreased susceptibility to encapsulated bacteria infections, especially infections caused
by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae,and to a lesser extent, Neisseria gonorrhoeae. If ULTOMIRIS therapy is administered topatients with active systemic infections, monitor closely for signs and symptoms ofworsening infection.
5.3Monitoring Disease Manifestations after ULTOMIRIS
Discontinuation
After discontinuing treatment with ULTOMIRIS, closely monitor for signs and
symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNHclone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria,abdominal pain, shortness of breath (dyspnea), major adverse vascular event (includingthrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinuesULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions.
If signs andsymptoms of hemolysis occur after discontinuation, including elevated LDH, considerrestarting treatment with ULTOMIRIS.
5.4 Thromboembolic Event Management
The effect of withdrawal of anticoagulant t |
