o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is treated with LIBTAYO.

o Description of the main signs or symptoms of the immune mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune mediated skin adverse reactions, nephritis and other imARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.

o The contact details of their LIBTAYO prescriber.

o The importance of not attempting to self treat any symptoms without consulting their healthcare professional first.

o The importance of carrying the Patient Alert Card at all times and to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).

o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities.