Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris ® (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.
The
administration of particulate, if present in a parenteral drug, poses a
potential safety risk to patients in two general areas: immunogenicity
and thromboembolic events. Particulates could cause blockage of flow of
blood in vessels, which could be life-threatening. To date, there have
been no product complaints of particulates, or identifiable safety
concerns attributed to the product consumed from the affected lots. As
previously stated, Alexion does not anticipate any interruption to
patient supply of Soliris.
The product is
approved as a treatment for patients with paroxysmal nocturnal
hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare
disorders. 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 was last shipped on Nov. 1, 2013, Alexion believes
there is little, if any, inventory currently being held at the hospital
or user level.
The following table lists the two affected lots, which were distributed nationwide.
| Product | Lot | Expiration Date | First Ship Date | Last Ship Date |
|---|---|---|---|---|
| Soliris® (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01 | 10010A | Oct. 31, 2015 | Oct. 11, 2013 | Nov. 1, 2013 |
| 10001-1 | July 31, 2014 | June 4, 2012 | May 8, 2013 |
As
previously disclosed, Alexion believes that it has identified the
filling process step that resulted in the presence of the visible
particles and implemented the change necessary to correct the issue. To
date, visible particles have not been observed in other lots of Soliris
distributed in the U.S.
