REGULATORY UPDATE: Kamada Announces Availability of Rho(D) Immune Globulin Product

Kamada Pharmaceuticals announced the limited availability of the company’s Rho(D) immune globulin (human) product April 1, which may provide facilities with more flexible options to manage their inventory. In a letter to health care providers, the company stated that the WinRho SDF strength 1,500 international units (300 micrograms per vial) is now available for purchase.

Kamada representatives noted, however, that given the current shortage situation of Rho(D) immune globulin (human) competitor product(s), transfusion services may be using other strengths of WinRho SDF. Accordingly, the letter focuses on dosing considerations for WinRho SDF and the availability of additional vial strengths. AABB encourages facilities to carefully review the letter to ensure an understanding of the appropriate use of this product, the flexibility provided by individual vials of 300 mcg and the appropriate dosing for the variety of uses.

The Food and Drug Administration updated its CBER-Regulated Products: Current Shortages web page to reflect this development. The agency first announced shortages of several products related to the blood and biotherapies community, including Rho(D) immune globulin, in February.

AABB is developing an Association Bulletin to provide facilities with resources to inform clinical practice decisions and inventory management during this shortage.