-- Alexion's global supply chain continues to provide Soliris to commercial and clinical patients without interruption --
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, 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. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As product from the affected lot was last shipped on
Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening 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 from the identified lots was last shipped on
The following table lists the lots that are being recalled, which were distributed in the U.S. to wholesalers, hospitals and pharmacies:
| Product | Lot | Expiration Date | First Ship Date | Last Ship Date | ||||
|
Soliris®(eculizumab) Concentrated solution for |
10007A | |||||||
| 10002-1 | ||||||||
| 00006-1 | ||||||||
| 10003A | ||||||||
| 10004A | ||||||||
| 10005A | ||||||||
| 10005AR | ||||||||
| 10006A | ||||||||
| 10008A | ||||||||
Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products. Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747), Monday-Friday from
Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747, Monday-Friday from
Adverse reactions or quality problems experienced with the use of this product may be reported to the
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular mail or fax: Download form to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-
FDA -0178.
This recall is being conducted with the knowledge of the
About Soliris® (eculizumab)
Soliris® (eculizumab) is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S. (2007),
Important Safety Information
The U.S. product label for Soliris includes a boxed warning: "Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)]. Comply with the most current
In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is not indicated for the treatment of patients with
About Alexion
Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH and aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates, including asfotase alfa, across multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexionpharma.com.
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Safe Harbor Statement
This news release includes forward-looking statements relating to continued adequacy of supply of Soliris, and identification and correction of the cause of the visible particles. These statements are subject to risks, uncertainties and other factors, including risks related to continuous product inventory and supply, the uncertainties involved in manufacturing of biologic products, and whether the
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