Genentech Patient Foundation/Medvantx Announce Ancillary Safety Issue

Industry NewsHFA has received the following notice from Genentech regarding the shipment of incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation:

We were recently informed that ancillary supplies shipped by a specialty pharmacy, Medvantx, to a specific group of patients receiving Hemlibra through the Genentech Patient Foundation contained incorrect length injection needles.

Medvantx and the Genentech Patient Foundation are working to resolve this issue as quickly as possible, and have reached out directly to the patients who were impacted and their physicians to prevent improper administration of Hemlibra. For these patients and physicians, more information was provided in a detailed letter outlining what to do and who to contact with any questions. We have confirmed that the vials of Hemlibra shipped to patients are not impacted in any way and are safe to use, with an appropriately sized injection needle.

We are also in the process of conducting a thorough investigation with Medvantx to ensure future shipments of Hemlibra only include approved ancillary supplies.

For any patients who have used the incorrect length needles and who experience any adverse effects, please contact the FDA at 1-800-FDA-1088 or Genentech at 1-888-835-2555.”

Genentech has also released copies of the letters the Genentech Patient Foundation sent to patients and to health care providers regarding the shipment of incorrect length injection needles.
HFA and NHF have questions for Genentech about how this error occurred. We will keep the bleeding disorders community informed as we explore these follow-up questions with Genentech.
Please note that HFA and NHF do not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. Please consult your physician before use of any treatments.