Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 31, 2019

Ravulizumab-cwvz

(Ultomiris—Alexion)
Ravulizumab-cwvz approved for atypical hemolytic uremic syndrome

Alexion announced FDA approval of ravulizumab-cwvz for treatment of adults and pediatric patients ages 1 month and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). Atypical HUS is an ultrarare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. Atypical HUS can cause sudden organ failure or a slow loss of function over time—potentially resulting in the need for a transplant, and in some cases, death.

Atypical HUS affects both adults and children and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. The prognosis of aHUS can be poor in many cases, so a timely and accurate diagnosis—in addition to treatment—is critical to improving patient outcomes.

Ravulizumab-cwvz is the first and only long-acting C5 complement inhibitor.

Common adverse reactions of ravulizumab-cwvz are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension, and pyrexia. Serious meningococcal infections have occurred in patients treated with ravulizumab-cwvz. To minimize the risk for patients, specific risk-mitigation plans, including a REMS, have been established.

It is administered intravenously every 8 weeks or every 4 weeks for pediatric patients less than 20 kg, following a loading dose.