Immune-mediated adverse reactions on therapy with LIBTAYO1*
The safety of LIBTAYO was evaluated in 810 patients with advanced solid malignancies1
*Important immune-mediated adverse reactions listed here may not be inclusive of all possible severe and fatal
†3 patients received additional immunosuppression with mycophenolate.
‡Can cause hypopituitarism.
§Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been
||Majority of patients required long-term thyroid hormone replacement.
¶Can present with diabetic ketoacidosis.
#Exfoliative dermatitis, including SJS, TEN, and DRESS, has occurred with PD-1/PD-L1–blocking antibodies.
DRESS=drug rash with eosinophilia and systemic symptoms; NR=Not reported in the USPI. Does not necessarily mean
the value is 0 and may have occurred in a small percentage of patients; SJS=Stevens-Johnson syndrome; TEN=toxic
PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1.
**These immune-mediated adverse reactions occurred in patients who received LIBTAYO or were reported with
the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of
these adverse reactions.
††Includes myocarditis, pericarditis, and vasculitis.
§§Includes uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with
retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis
occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like
syndrome, as this may require treatment with systemic corticosteroids to reduce the risk of permanent
IIIIIncludes pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis,
¶¶Includes myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure,
arthritis, and polymyalgia rheumatica.