IMJUDO (tremelimumab-actl)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hyperglycemia
Hyperthyroidism
Hypothyroidism
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 41 severe adverse reactions.

More Frequent	Less Frequent
Anemia Hyperbilirubinemia Hyponatremia Increased alanine transaminase Increased alkaline phosphatase Increased aspartate transaminase Lymphopenia	Adrenocortical insufficiency Autoimmune hepatitis Colitis Hyperthyroidism Hypophysitis Hypothyroidism Interstitial nephritis Interstitial pneumonitis Pancreatitis Thyroiditis

Rare/Very Rare

Acute inflammatory syndrome Aplastic anemia Autoimmune encephalitis Autoimmune hemolytic anemia Autoimmune thrombocytopenia Demyelinating disorder Duodenitis Encephalitis Guillain-barre syndrome Hemophagocytic lymphohistiocytosis Histiocytic necrotizing lymphadenitis Hypoparathyroidism Iritis Meningitis Myocarditis Myositis Pericarditis Polymyalgia rheumatica Polymyositis Retinal detachment Rhabdomyolysis Sarcoidosis Uveitis Vasculitis

There are 15 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anorexia Diarrhea Fatigue Musculoskeletal pain Nausea Pruritus of skin Skin rash	Headache disorder Hyperglycemia Skin inflammation

Rare/Very Rare
Arthritis Gastritis Muscle weakness Peripheral sensory neuropathy

There are no available data on the use of tremelimumab in pregnant women. However, based on findings from animal studies and its mechanism of action, tremelimumab can cause fetal harm when administered to a pregnant woman. Administration of tremelimumab to pregnant cynomolgus monkeys during the period of organogenesis was not associated withadverse maternal or embryo-fetal effects at exposure levels approximately 4-31 times higher than those observed at a recommended dose range of 75-300 mg based on AUC.

In a murine modelof pregnancy,CTLA-4 blockade was associated with anincreased risk of immune-mediated rejection of the developing fetus and fetal death. Based on the mechanism of action of tremelimumab, fetal exposure to the drug may increase the risk of developing immune-mediated disorders or altering the normal immune response. Human immunoglobulin G2 (IgG2) is known to cross the placental barrier; therefore, tremelimumab may be transmitted from the mother to the developing fetus. Advise pregnant women and females of reproductive potential of the potential risk to the fetus.

It is not known whether tremelimumab is distributed into human milk; the effects of the drug on breast-fed infants or on milk production also areunknown. Maternal IgG is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breast-fed child to tremelimumab are unknown.

Due to the potential for serious adverse reactions in the breast-fed child, advise women not to breast-feed during treatment with tremelimumab and for 3 months after the last dose. Consult the full prescribing information for breast-feeding considerations of agents administered in combination with tremelimumab.

The manufacturer makes no specific dosage recommendations for geriatric patients. In clinical studies of patients with unresectable hepatocellular carcinoma or metastatic non-small cell lung cancer treated with tremelimumab in combination with durvalumab, no overall differences in safety or efficacy of tremelimumab were observed between patients 65 years of ageor older and younger adults.