Imjudo Special Precautions

Refer to Dosage & Administration, Table 3 for recommended treatment modifications and management of immune-mediated adverse reactions.
Immune-mediated pneumonitis: Immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for signs and symptoms of pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging and other infectious and disease-related etiologies excluded, and managed as recommended in Dosage & Administration.
Immune-mediated hepatitis: Immune-mediated hepatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for abnormal liver prior to initiation of treatment and prior to each subsequent infusion. Immune-mediated hepatitis should be managed as recommended in Dosage & Administration.
Immune-mediated colitis: Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Intestinal perforation and large intestine perforation were reported in patients receiving IMJUDO in combination with durvalumab. Patients should be monitored for signs and symptoms of colitis/diarrhoea and intestinal perforation and managed as recommended in Dosage & Administration.
Immune-mediated endocrinopathies: Immune-mediated hypothyroidism/hyperthyroidism/thyroiditis: Immune-mediated hypothyroidism, hyperthyroidism or thyroiditis have occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and managed as recommended in Dosage & Administration.
Immune-mediated adrenal insufficiency: Immune-mediated adrenal insufficiency occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for clinical signs and symptoms of adrenal insufficiency and managed as recommended in Dosage & Administration.
Immune-mediated type 1 diabetes mellitus: Immune-mediated type 1 diabetes mellitus, which can present with diabetic ketoacidosis that can be fatal if not detected early, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus and managed as recommended in Dosage & Administration.
Immune-mediated hypophysitis/hypopituitarism: Immune-mediated hypophysitis or hypopituitarism occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism and managed as recommended in Dosage & Administration.
Immune-mediated nephritis: Immune-mediated nephritis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for abnormal renal function tests prior to and periodically during treatment with IMJUDO in combination with durvalumab and managed as recommended in Dosage & Administration.
Immune-mediated rash: Immune-mediated rash or dermatitis (including pemphigoid), defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Events of Stevens-Johnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 and CTLA-4 inhibitors. Patients should be monitored for signs and symptoms of rash or dermatitis and managed as recommended in Dosage & Administration.
Immune-mediated myocarditis: Immune-mediated myocarditis, which can be fatal, occurred in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions). Patients should be monitored for signs and symptoms of immune-mediated myocarditis and managed as recommended in Dosage & Administration.
Other immune-mediated adverse reactions: Given the mechanism of action of IMJUDO and durvalumab, other potential immune-mediated adverse reactions may occur in patients receiving the combination of IMJUDO with durvalumab. The following immune-mediated adverse reactions have been observed: myasthenia gravis, myositis, polymyositis, Guillain-Barré syndrome, meningitis, cystitis noninfective, immune thrombocytopenia, pancreatitis, hemophagocytic lymphohistiocytosis, autoimmune hemolytic anemia, aplastic anemia, immune-mediated arthritis, uveitis, and encephalitis (see Adverse Reactions). Iritis, and other ocular inflammatory toxicities can occur. 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 steroids to reduce the risk of permanent vision loss. Patients should be monitored for signs and symptoms and managed as recommended in Dosage & Administration.
Infusion-related reactions: Patients should be monitored for signs and symptoms of infusion-related reactions and managed as recommended in Dosage & Administration. Severe infusion-related reactions have been reported in patients receiving IMJUDO in combination with durvalumab (see Adverse Reactions).
Effects on ability to drive and use machines: Based on its pharmacodynamic properties, tremelimumab is unlikely to affect the ability to drive and use machines. However, if patients experience adverse reactions affecting their ability to concentrate and react, they should be advised to use caution when driving or operating machinery.