Voluntary Recall Issued for Batch of Mononine, Hemophilia B Treatment

CSL Behring has issued a voluntary, pharmacy level recall covering one batch of Mononine, its long-standing treatment for preventing and controlling bleedings in people with hemophilia B that is soon to be discontinued.

According to the company’s statement, the recall is a precautionary measure due to a manufacturing problem that occurred during the filling process for that batch of Mononine.

The potential safety risk to patients already in the possession of this particular lot — P100125501; expiration date 8/28/2021 — is considered low but “cannot be fully excluded,” the company said.

“We recognize the concern this presents for patients, physicians and pharmacists, and will keep the community apprised of the situation,” it added.

Patients on Mononine are advised to check their medication’s batch number and contact their pharmacy regarding prescriptions, as well as their healthcare provider regarding their treatment plan.

Patients wanting to know more about the potential health risks of this lot can call CSL Behring Medical Information at 1-800-504-5434, Monday–Friday 9 a.m. to 5 p.m. ET.

In a separate announcement, the National Hemophilia Foundation stated that it is in contact with CSL Behring to obtain additional information regarding the events that led up to the recall, and on how the company plans to publicize and accomplish the recall.

Mononine is a type of replacement therapy that involves supplying plasma-derived factor IX, the blood coagulation protein missing or defective in hemophilia B, to patients. Plasma is the cell-free liquid part of blood.

Administered directly into the bloodstream, Mononine became the first highly purified factor IX approved by the U.S. Food and Drug Administration in 1992.

CSL Behring announced in September that it would be discontinuing the therapy due to its declining demand in recent years, mainly associated with the emergence of next-generation factor IX treatments.

The company anticipates that current supplies will last until at least mid-year, giving enough time for patients to discuss potential alternative treatments with their medical team.

More recent treatment options for hemophilia B include AlphaNine SD, another plasma-derived factor IX, as well as Rixubis and Alprolix — two recombinant factor therapies that deliver an engineered, similar version of factor IX to patients.