Why EMPAVELI
What is EMPAVELI? Discover what’s possible with EMPAVELI EMPAVELI is a prescription medicine used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
EMPAVELI was studied in two Phase 3 clinical trials to find out how effective and safe EMPAVELI is in treating PNH:
Previous C5i treatment (PEGASUS)
No previous complement inhibitor treatment (PRINCE)
Compared EMPAVELI to a C5i treatment (eculizumab) in 80 adults with PNH who had previously received a C5i
Compared EMPAVELI to a control arm* (without EMPAVELI or any other complement inhibitor) in 53 adults with PNH who had never received a complement inhibitor
See how EMPAVELI was studied in PRINCE
See how EMPAVELI was studied in PEGASUS
*People in the control arm could continue taking stable doses of their medications for PNH except for EMPAVELI or any other complement inhibitors (like eculizumab or ravulizumab).
IMPORTANT SAFETY INFORMATION (cont’d) What is the most important information I should know about EMPAVELI? (cont'd) Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 months after your last EMPAVELI dose. Your risk of serious infections may continue for several weeks after your last dose of EMPAVELI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly. EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must enroll in the EMPAVELI REMS program, counsel you about the risk of serious infections caused by certain bacteria, give you information about the symptoms of serious infections, make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start EMPAVELI right away and you are not up to date on your vaccines, and give you a Patient Safety Card about your risk of serious infections.
Monica is an adult with PNH who's taken EMPAVELI.
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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