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) Compared EMPAVELI to a C5i treatment (eculizumab) in 80 adults with PNH who had previously received a C5i
No previous C5i treatment (PRINCE) Compared EMPAVELI to a control arm* (without EMPAVELI or C5i treatment) in 53 adults with PNH who had never received a C5i
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 C5i treatments (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. It is important to show this card to any healthcare provider to 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, give you a Patient Safety Card about your risk of serious infections, and make sure that you are vaccinated.
Monica is an adult with PNH taking 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.
8
9
Made with FlippingBook flipbook maker