ypopituitarism. Administer corticosteroids and hormone replacement as clinically indicated [see DOSAGE AND ADMINISTRATION (2.2)]. Hypopituitarism leading to adrenal insufficiency and diabetes insipidus occurred in one patient (<0.1%) in the combined safety database.
5.5 Other Immune-Mediated Adverse Reactions
IMFINZI has caused immune-mediated rash. Other immune-related adverse reactions, including aseptic meningitis, hemolytic anemia, immune thrombocytopenic purpura, myocarditis, myositis, nephritis, and ocular inflammatory toxicity including uveitis and keratitis, have occurred in ≤1.0% of patients treated with IMFINZI.
Immune-mediated Rash
Monitor for signs and symptoms of rash [see DOSAGE AND ADMINISTRATION (2.2)]. In Study 1, 20 (11.0%) of patients developed rash including Grade 3 rash in one (0.5%) patient. In the combined safety database, 220 (15.6%) patients developed rash and four (0.3%) patients developed vitiligo. Systemic corticosteroids were administered in 17 (1.2%) patients. The rash resolved in 133 (9.4%) patients.
Immune Thrombocytopenic Purpura
Monitor patients for signs and symptoms of immune thrombocytopenic purpura [see DOSAGE AND ADMINISTRATION (2.2)]. In the combined safety database, immune thrombocytopenic purpura led to death in one (<0.1%) patient. The patient received high-dose corticosteroids, human immunoglobulin, and rituximab.
Nephritis
Monitor patients for abnormal renal function tests prior to and each cycle during treatment with IMFINZI and manage with treatment modifications and corticosteroids [see DOSAGE AND ADMINISTRATION (2.2)]. In Study 1, one patient received systemic corticosteroids for immune-mediated nephritis. In the combined safety database, immune-mediated nephritis occurred in three (0.2%) patients including Grade 3 in two (0.1%) patients. All three patients received high-dose corticosteroids treatment. IMFINZI was discontinued in all three patients. Resolution occurred in all three patients.
5.6 Infection
Severe infections, including sepsis, necrotizing fasciitis, and osteomyelitis, occurred in patients receiving IMFINZI. Monitor patients for signs and symptoms of infection and treat with anti-infectives for suspected or confirmed infections. Withhold IMFINZI for ≥Grade 3 infection [see DOSAGE AND ADMINISTRATION (2.2) and ADVERSE REACTIONS (6.1)].
In Study 1, infections occurred in 54 (29.7%) patients. Grade 3 or 4 infection occurred in eleven (6.0%) patients, while five (2.7%) patients were experiencing infection at the time of death. Urinary tract infections were the most common cause of Grade 3 or higher infection, occurring in eight (4.4%) patients. In the combined safety database, infections occurred in 531 (37.6%) patients.
5.7 Infusion-Related Reactions
Severe infusion-related reactions have been reported in patients receiving IMFINZI. Monitor for signs and symptoms of an infusion-related reaction. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Permanently discontinue IMFINZI in patients with Grade 3 or 4 infusion reactions [see DOSAGE AND ADMINISTRATION (2.2)].
Infusion related reactions occurred in three (1.6%) patients in Study 1 and 26 (1.8%) patients in the combined safety database. There were five (0.4%) Grade 3 and no Grade 4 or 5 reactions. Four (0.3%) patients developed urticaria within 48 hours of dosing.
5.8 Embryo-Fetal Toxicity
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