herapy during ULTOMIRIS treatment has notbeen established. Therefore, treatment with ULTOMIRIS should not alter anticoagulantmanagement.
5.5 Infusion Reactions
Administration of ULTOMIRIS may result in infusion reactions. In clinical trials, 3 outof 222 patients with PNH treated with ULTOMIRIS experienced infusion reactions
(lower back pain, drop in blood pressure and infusion-related pain) during ULTOMIRISadministration. These reactions did not require discontinuation of ULTOMIRIS. InterruptULTOMIRIS infusion and institute appropriate supportive measures if signs ofcardiovascular instability or respiratory compromise occur.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail inother sections of the labeling:
•Serious Meningococcal Infections [see Warnings and Precautions (5.1)]
•Other Infections [see Warnings and Precautions (5.2)]
•Monitoring PNH Disease Manifestations after ULTOMIRIS Discontinuation[see Warnings and Precautions (5.3)]
•Infusion Reactions [see Warnings and Precautions (5.5)]
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reactiorates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure of 441 adult patients with PNH in Phase 3studies who received ULTOMIRIS (n = 222) or eculizumab (n = 219) at therecommended dosing regimens with median treatment duration of 6 months forULTOMIRIS and 6 months for eculizumab. The most frequent adverse drug reactions(>10%) with ULTOMIRIS were upper respiratory tract infection and headache.
Table 4describes adverse reactions that occurred at a rate of 5% or more among patients treatedwith ULTOMIRIS.
Serious adverse reactions were reported in 15 (6.8%) patients receiving ULTOMIRIS.
The serious adverse reactions in patients treated with ULTOMIRIS includedhyperthermia and pyrexia. No serious adverse reaction was reported in more than 1
patient treated with ULTOMIRIS.
One fatal case of sepsis was identified in a patient treated with ULTOMIRIS.
Table 4: Adverse Reactions Reported In 5% or More of ULTOMIRIS Treated
Patients in Complement Inhibitor Naïve and EculizumabExperienced
Patients with PNH
Number of Patients
Body System ULTOMIRIS Eculizumab
Adverse Reaction (n=222) (n=219)
n (%) n (%)
Number of Patients
Body System ULTOMIRIS Eculizumab
Adverse Reaction (n=222) (n=219)
n (%) n (%)
Gastrointestinal disorders
Diarrhea 19 (9) 12 (5)
Nausea 19 (9) 19 (9)
Abdominal pain 13 (6) 16 (7)
General Disorders and Administration Site
Conditions
Pyrexia 15 (7) 18 (8)
Infections and Infestations
Upper respiratory tract infectiona 86 (39) 86 (39)
Musculoskeletal and Connective Tissue
Disorders
Pain in extremity 14 (6) 11 (5)
Arthralgia 11 (5) 12 (5)
Nervous System Disorders
Headache 71 (32) 57 (26)
Dizziness 12 (5) 14 (6) a Grouped term includes: Nasopharyngitis, Upper respiratory tract infection, Oropharyngeal pain, Viral
upper respiratory tract infection, Rhinitis, Respiratory tract infection, Rhinorrhoea, Pharyngitis, and
Upper respiratory tract inflammation
6.2 Immunogenicity
As with all therapeutic proteins, there is p |
