DHPC – Opdualag® (nivolumab, relatlimab)

Error in section “Other information, Instructions for handling” in the Information for healthcare professionals

23.06.2023
Product Opdualag, concentrate for solution for infusion
Authorisation number 68609
Active substances relatlimabum, nivolumabum
Marketing authorisation holder Bristol-Myers Squibb SA

The company has announced that there is an error regarding concentration/dilution in Information for healthcare professionals enclosed in the packaging.

In the section “Other information, Instructions for handling”, the lower limit of the final concentration for infusion is wrongly given as 1.5 mg/mL nivolumab and 0.5 mg/mL relatlimab. The correct lower limit is 3 mg/mL nivolumab and 1 mg/mL relatlimab, which results in a maximum total volume for infusion of 160 mL.

Further information can be found in the information letter from the company.