Soliris FDA Alerts

Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates

ISSUE: Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30 mL concentrated solution for intravenous infusion. 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. 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.

BACKGROUND: 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 October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.

RECOMMENDATION: 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 8:30am to 5:00pm Eastern Time (ET). Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products.

Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747, Monday-Friday from 8:30am to 5:00pm ET. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Unaffected lot numbers can continue to be used according to the instructions for use.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 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

[06/02/2014 - Recall Notice - FDA]
[06/02/2014 - Product Photos - FDA]

Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles

ISSUE: Alexion Pharmaceuticals, Inc. is providing 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.

BACKGROUND: 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.  Soliris (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01, Lot number: 10010A and 10001-1.

RECOMMENDATION: 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).
Alexion will replace any recalled vials of Soliris. Unaffected lot numbers can continue to be used according to the instructions for use. Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 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.

[12/13/2013 - Press Release - Alexion]