Immune-mediated adverse reactions on therapy with LIBTAYO1*

The safety of LIBTAYO was evaluated in 810 patients with advanced solid malignancies1

The safety of LIBTAYO was evaluated in 810 patients with advanced solid malignancies
  • *Important immune-mediated adverse reactions listed here may not be inclusive of all possible severe and fatal immune-mediated reactions.
  • 3 patients received additional immunosuppression with mycophenolate.
  • Can cause hypopituitarism.
  • §Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported.
  • ||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 epidermal necrolysis.
Other immune-mediated adverse reactions
  • **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 meningitis, encephalitis, myelitis, demyelination, myasthenic syndrome/ myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy.
  • §§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 vision loss.
  • IIIIIncludes pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, and stomatitis.
  • ¶¶Includes myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, and polymyalgia rheumatica.
  • ##Includes hypoparathyroidism.
  • ***Includes hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, and solid organ transplant rejection.

Reference: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron PharmaceuticaIs, Inc., and sanofi-aventis U.S. LLC.