Imjudo Patient Counseling Information

Advise the patient to read the patient labeling (Patient Information Leaflet).
Immune-Mediated Adverse Reactions: Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of IMJUDO in combination with durvalumab, including [see Severe and Fatal Immune-Mediated Adverse Reactions under Precautions]: Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath.
Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain.
Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding.
Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis.
Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
Dermatological Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions.
Pancreatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pancreatitis.
Other Immune-Mediated Adverse Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of aseptic meningitis, immune thrombocytopenia, myocarditis, hemolytic anemia, myositis, uveitis, keratitis, and myasthenia gravis.
Infusion-Related Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Infusion-Related Reactions under Precautions].
Embryo-Fetal Toxicity: Advise females of reproductive potential that IMJUDO can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Embryo-Fetal Toxicity under Precautions; Pregnancy, and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of IMJUDO [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise female patients not to breastfeed while taking IMJUDO and for 3 months after the last dose [see Lactation under Use in Pregnancy & Lactation].