Possible side effects
Most common side effects
Infections
Abdominal pain
Injection site reactions
Diarrhea
Respiratory tract infection Viral infection
Tiredness
EMPAVELI is only available through a program called the EMPAVELI REMS (Risk Evaluation and Mitigation Strategy). REMS is a safety program run by the FDA. Before you can take EMPAVELI, your healthcare provider must enroll in the program and will provide you with the following: Counseling on the risk of serious infections caused by certain bacteria Information about the symptoms of serious infections Appropriate vaccinations against serious infections caused by encapsulated bacteria – You will receive antibiotics if you need to start EMPAVELI right away and are not up to date on your vaccines A Patient Safety Card – Carry this card with you at all times during treatment and for 2 months after your last EMPAVELI dose – Show this card to any healthcare professional to help diagnose and treat you quickly – Your risk of serious infection may continue for several weeks after your last dose of EMPAVELI EMPAVELI REMS program ensures your safety is a top priority
Serious adverse reactions were reported in 17% of patients treated with EMPAVELI - T he most common serious adverse events were infections (5%) Injection/infusion site reactions were mild or moderate in severity. Seventeen cases of diarrhea were reported during the 48 weeks. Fifteen of the cases were mild and 2 were moderate Breakthrough hemolysis occurred in 10% of those taking EMPAVELI vs 23% of those taking eculizumab at Week 16 in the PEGASUS study. Three people taking EMPAVELI left the study due to hemolysis
Injection site reactions
Infections
Viral infection
Pain in extremity
Low potassium
Joint pain
Dizziness
Abdominal pain
Rash
Headache
One patient treated with EMPAVELI died due to septic shock Serious adverse reactions were reported in 13% of patients treated with EMPAVELI Overall, there were no EMPAVELI-related side effects leading to drug or trial discontinuation No events of acute hemolysis were observed in either treatment group through Week 26 These are not all the possible side effects of EMPAVELI. Be sure to tell your healthcare provider about any side effect that bothers you or that does not go away. Side effects can be reported to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Two people taking EMPAVELI in the PEGASUS and PRINCE studies had side effects related to blood clots. They were deemed not related to EMPAVELI There have been no cases of meningococcal infections in any adults with PNH treated with pegcetacoplan, as of 11/13/2023. They were vaccinated prior to treatment with pegcetacoplan
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.
26
27
Made with FlippingBook - professional solution for displaying marketing and sales documents online