Ravulizumab-cwvz
Class: Complement Inhibitors
Chemical Name: Immunoglobulin G2/G4, anti-(human complement C5) (human-Mus musculus ALXN1210 heavy chain), disulfide with human-Mus musculus ALXN1210 κ-chain, dimer
Molecular Formula: C6430H9888N1696O2028S48
CAS Number: 1803171-55-2
Brands: Ultomiris
Warning
Warning: Serious Meningococcal Infections
See full prescribing information for complete boxed warning.
Life-threatening meningococcal infections/sepsis have occurred in patients treated with ravulizumab-cwvz and may become rapidly life-threatening or fatal if not recognized and treated early.
Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ravulizumab-cwvz, unless the risks of delaying ravulizumab-cwvz therapy outweigh the risks of developing a meningococcal infection. Vaccination reduces, but does not eliminate, the risk of meningococcal infection.
Monitor patients for early signs of meningococcal infections, and evaluate immediately if infection is suspected.
Ravulizumab-cwvz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ravulizumab-cwvz REMS, prescribers must enroll in the program.
Risk Evaluation and Mitigation Strategy (REMS):
FDA approved a REMS for ravulizumab-cwvz to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of ravulizumab-cwvz and consists of the following: elements to assure safe use. See https://www.accessdata.fda.gov/scripts/cder/rems/.
Introduction
Ravulizumab-cwvz is a complement inhibitor.
Uses for Ravulizumab-cwvz
Ravulizumab-cwvz has the following uses:
Ravulizumab-cwvz is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Ravulizumab-cwvz Dosage and Administration
General
Ravulizumab-cwvz is available in the following dosage form(s) and strength(s):
Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial.
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
Only administer as an intravenous infusion.
Recommended dosing regimen consists of a loading dose followed by maintenance dosing. Starting 2 weeks after the loading dose administration, begin maintenance doses at once every 8-week intervals.
Recommended doses are based on the patient's body weight as shown in the following table:
Body Weight Ran... MEDICAL DEPARTMENTS
Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram
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