Lengthy shortage forecast for Rebinyn 3,000 IU for hemophilia B

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Unexpectedly high demand for the 3,000 international units (IU) vial size of Rebinyn (nonacog beta pegol) has resulted in a temporary shortage of the Novo Nordisk factor IX (FIX) replacement therapy for those with hemophilia B, according to the company.

In a statement, Novo Nordisk said it expects the shortage — which it attributed to demand that “outpaced our expectations” — to lead to an “intermittent supply” of the vial size over the next couple of months.

However, overall supplies of the 500, 1,000, and 2,000 IU vials will be maintained, the company said. That will allow patients who had been using the 3,000 IU single-use vials to use a combination of the other Rebinyn strengths to make up the appropriate dose. Patients with questions about how to make the proper dose were advised to contact their healthcare provider.

“Novo Nordisk recognizes the inconvenience this may cause … and we are working hard to resolve this issue to establish a consistent supply of the 3,000 IU vial size,” the company stated.

The company advises patients who have questions about the temporary shortage to contact their Novo Nordisk community liaison, their healthcare provider, or Novo Nordisk Customer Care, which can be reached by calling 800-727-6500.

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Hemophilia B is caused by mutations in the F9 gene, which provides instructions for making FIX, a blood clotting protein that’s necessary for bleed-halting blood coagulation. Mutations can impair the production and function of FIX in the body, causing patients to experience excessive and prolonged bleeding.

Replacement therapies that work to provide patients with a functional version of the FIX protein they are missing are considered a mainstay treatment for the condition.

Rebinyn is one such therapy, and is used as a preventive and on-demand treatment for bleeds, as well as to manage bleeds occurring around the time of surgery. It’s an extended half-life product, meaning the FIX it contains was modified to last longer in the body. This enables the therapy to be given lessen often compared with other replacement treatments.

The therapy was first approved in the U.S. in 2017 for adults and children with hemophilia B as an on-demand or surgical treatment to control bleeds. That approval was expanded in 2022, permitting Rebinyn to be used as a routine preventive treatment in the same patient population.

Rebinyn is given intravenously, or via an into-the-vein infusion. It may be administered at a healthcare provider’s office, at a hemophilia treatment center, or at home.

Before being administered, Rebinyn must be diluted in an appropriate liquid solution that is provided in a pre-filled syringe. After dilution, the 3,000 IU vial size, which became available last May, provides about 750 IU of FIX per mL. Treatment dosage and duration depend on the specific indication for which the therapy is being used, on the bleed’s extent and location, and on the patient’s clinical condition.

News of the shortage was communicated via email as “an important update.”

“We are committed to acting in your best interest and Novo Nordisk remains steadfast in our commitment to this community,” the company stated. “We thank you for your patience and will continue to share updates as they become available to keep you informed.”

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