Extract

Pegcetacoplan is a complement inhibitor.

Class: 92:32 • Complement Inhibitors (AHFS primary)

Brands: Empaveli®

REMS

FDA approved a REMS for pegcetacoplan to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of pegcetacoplan. See the FDA REMS page (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm).

Uses

Pegcetacoplan has the following uses:

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Dosage and Administration

General

Pegcetacoplan is available in the following dosage form(s) and strength(s):

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Dosage

It isessentialthat the manufacturer’s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

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Cautions

Contraindications

Pegcetacoplan is contraindicated in:

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Warnings/Precautions

Serious Infections Caused by Encapsulated Bacteria

The use of pegcetacoplan may predispose individuals to serious, life-threatening, or fatal infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B (Hib). To reduce the risk of infection, all patients must be vaccinated against these bacteria according to the most current ACIP recommendations for patients with altered immunocompetence associated with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with pegcetacoplan.

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