Certain lots of Soliris (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion were recalled due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing. The manufacturer, Alexion, believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process.
The single affected, Soliris lot, #10007A, was distributed only in the U.S. However, additional lots, which were produced with the same process component during vial filling, and that currently remain in specification, are being included within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.
Soliris® (eculizumab) is a first-in-class terminal complement inhibitor. Soliris is approved in the U.S. (2007), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is indicated to reduce hemolysis in PNH patients. Soliris is also approved in the U.S. (2011), the European Union (2011), Japan (2013) and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic disorder characterized by complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels). The effectiveness of Soliris in aHUS is based on the effects on TMA and renal function. Soliris is not indicated for the treatment of patients with Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication