Pegcetacoplan (Subcutaneous)
Medically reviewed by Drugs.com. Last updated on Jun 7, 2022.
Warning: Serious Infections Caused by Encapsulated BacteriaMeningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use of pegcetacoplan may predispose individuals to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B and Haemophilus influenzae type B.Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients with altered immunocompetence associated with complement deficiencies.Vaccinate patients against encapsulated bacteria as recommended at least 2 weeks prior to administering the first dose of pegcetacoplan unless the risks of delaying therapy with pegcetacoplan outweigh the risk of developing a serious infection.Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of infections and evaluate immediately if infection is suspected.Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the EMPAVELI REMS, prescribers must enroll in the program. Enrollment in the EMPAVELI REMS program and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com .
Commonly used brand name(s)
In the U.S.
- Empaveli
Available Dosage Forms:
- Solution
Therapeutic Class: Blood Modifier Agent
Uses for pegcetacoplan
Pegcetacoplan injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.
Pegcetacoplan is available only under a restricted distribution program called Empaveli™ REMS (Risk Evaluation and Mitigation Strategy) Program.
Before using pegcetacoplan
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pegcetacoplan, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to pegcetacoplan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pegcetacoplan injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegcetacoplan injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Altho..
