How EMPAVELI can help | Hb NORMALIZATION
Getting to normalization of lab values What is normalization? How is it different than stabilization? Normalization means lab values improved to levels like those of adults who don’t have PNH. This is different than stabilization, which generally means that lab values did not get worse. Hemoglobin (Hb) normalization in people with and without previous complement inhibitor treatment This information is for observation only and no conclusions can be made on the effect of EMPAVELI on Hb normalization. No comparisons can be made between those taking EMPAVELI and those taking eculizumab in PEGASUS or those in the control arm (excluding complement inhibitors) in PRINCE.
Louis is an adult with PNH who's taken EMPAVELI.
In people who had never received a complement inhibitor (PRINCE)
In people who had previously received a C5i (PEGASUS)
At Week 26 in PRINCE
At Week 16 in PEGASUS
60
40
35
50
34%
30
46%
of people taking EMPAVELI achieved Hb normalization
of people taking EMPAVELI achieved Hb normalization
40
25
30
20
15
20
Hb normalization means their Hb got to within the normal range (12-16 g/dL for females, 13.6-18 g/dL for males).
Hb normalization means their Hb got to within the normal range (12-16 g/dL for females, 13.6-18 g/dL for males).
10
10
5
0%
0%
0
0
Control arm (excluding complement inhibitors) n=18
EMPAVELI n=35
EMPAVELI n=41
eculizumab n=39
These data include only people who did not require a transfusion during the study.
These data include only people who did not require a transfusion during the study.
IMPORTANT SAFETY INFORMATION (cont’d) What are the possible side effects of EMPAVELI? (cont'd) These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
C5i=C5 inhibitor; PNH=paroxysmal nocturnal hemoglobinuria.
Please see full Important Safety Information, including Boxed WARNING regarding risk of serious infections, on pages 38-39, and the full Prescribing Information and Medication Guide.
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