ISMP Canada News

March 2008: ALERT: Recent Change in Rituximab (Rituxan®) Labelling Leads to Reports of Mix-ups

ISMP Canada has received 6 reports regarding the new labelling for rituximab (Rituxan®). Four of these reports involved mix-ups between rituximab and trastuzumab (Herceptin®) vials, which fortunately were caught in the pharmacy before dispensing. Two reports identified look-alike concerns with these vials. The manufacturer of both products, Hoffmann-La Roche Ltd., recently changed the rituximab label from orange with black print to mainly white with dark blue print and orange print for the dose. (Figures 1 and 2; ISMP Canada thanks the reporter who submitted photographs with their report).

Rituximab is used in the treatment of non-Hodgkin’s lymphoma and rheumatoid arthritis, whereas trastuzumab is used, in conjunction with other medications, for the treatment of breast cancer. Both rituximab and trastuzumab require refrigeration, and they are likely to be stored side by side (e.g., if storage is in alphabetical order by generic name). Even though the trastuzumab is supplied as a powder, once reconstituted, the vial may be stored in the refrigerator without the original outer package.

ISMP Canada has notified the manufacturer and Health Canada. Hoffmann-La Roche Canada has indicated that the reason for the change in the rituximab label was to conform with the manufacturer’s global label format. The company noted that written notification of this change had been sent to customers and would continue to be reinforced by sales staff. In addition, a global review and revision of all product labelling is under way, with rituximab labelling scheduled for review during the summer of 2008. ISMP Canada hopes that the Hoffmann-La Roche parent company (in Switzerland) will consider these reports during the label redesign process and that development of a new label will be expedited.

In the interim, the following strategies which have been implemented by reporting facilities are suggested by ISMP Canada to reduce the possibility of error:

Do not store rituximab and trastuzumab in close proximity to each other in the pharmacy (e.g., store on separate shelves in refrigerator).
Consider applying auxiliary labels to enhance differentiation of the rituximab vials.
Share this alert to inform all staff about the potential for a mix-up.

Figure 1. From left to right: trastuzumab vial (440 mg/21 mL, reconsitituted) and previous rituximab vial (500 mg, 10mg/mL).

Figure 2. From left to right: trastuzumab vial (440 mg/21 mL, reconsitituted) and new rituximab vial (500 mg, 10mg/mL).