is class. Systemic corticosteroids were required in all patients with dermatologic reactions, including 89% who received prednisone ≥40 mg/day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately 22% of patients had recurrence of dermatologic reactions after re-initiation of LIBTAYO. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534 patients who received LIBTAYO or were reported with the use of other PD-1–blocking and PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy
Cardiovascular: Myocarditis, pericarditis, and vasculitides
Ocular: 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
Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, and duodenitis
Musculoskeletal and connective tissue: Myositis, rhabdomyolysis, and associated sequelae, including renal failure, arthritis, and polymyalgia rheumatica
Hematological and immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, and solid organ transplant rejection
Infusion-related reactions
Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving LIBTAYO. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or 2, and permanently discontinue for Grade 3 or.
Embryo-fetal toxicity
LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.
Adverse reactions
Serious adverse reactions occurred in 28% of patients. Serious adverse reactions that occurred in ≥2% of patients were cellulitis, sepsis, pneumonia, pneumonitis, and urinary tract infection. The most common Grade 3-4 adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia, musculoskeletal pain, skin infection, urinary tract infection, and fatigue
LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients; adverse reactions resulting |
