Ravulizumab (Ultomiris)

General information

Class/mechanism from the NCI Drug Dictionary: A longer-acting antibody directed against terminal complement protein C5, with potential anti-inflammatory activity. Upon administration, ravulizumab-cwvz binds to terminal complement protein C5, thereby blocking C5 cleavage into pro-inflammatory components and preventing the complement-mediated destruction of red blood cells (RBCs) as seen in paroxysmal nocturnal hemoglobinuria (PNH). Compared to other anti-C5 antibodies, ALXN1210 is longer-acting and allows for monthly dosing.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

• Link to REMS program

Diseases for which it is used

• Atypical hemolytic uremic syndrome
• Paroxysmal nocturnal hemoglobinuria

History of changes in FDA indication

• 2018-12-21: Initial approval for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). (Based on CHAMPION 301 & CHAMPION 302)

History of changes in EMA indication

• 2019-07-02: Initial authorization

History of changes in PDMA indication

• 2020-09-25: New indication and a new dosage for the treatment of atypical hemolytic uremic syndrome (aHUS).

Also known as

• Code name: ALXN-1210
• Generic name: ravulizumab-cwvz
• Brand name: Ultomiris