sed on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of durvalumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased premature delivery, fetal loss and premature neonatal death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI [see USE IN SPECIFIC POPULATIONS (8.1, 8.3)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling.
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Immune-Mediated Pneumonitis [see WARNINGS AND PRECAUTIONS (5.1) ].
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Immune-Mediated Hepatitis [see WARNINGS AND PRECAUTIONS (5.2) ].
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Immune-Mediated Colitis [see WARNINGS AND PRECAUTIONS (5.3) ].
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Immune-Mediated Endocrinopathies [see WARNINGS AND PRECAUTIONS (5.4)].
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Other Immune-Mediated Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.5)].
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Infection [see WARNINGS AND PRECAUTIONS (5.6)].
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Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS (5.7)].
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in Table 2 reflect exposure to IMFINZI in 182 patients with locally advanced or metastatic urothelial carcinoma in Study 1 whose disease has progressed during or after one standard platinum-based regimen. Patients received 10 mg/kg IMFINZI via intravenous infusion every 2 weeks [see CLINICAL STUDIES (14.1)]. The median duration of exposure was 10.2 weeks (range: 0.14, 52.4).
Thirty-one percent (31%) of patients had a drug delay or interruption for an adverse reaction. The most common (>2%) were liver injury (4.9%), urinary tract infection (3.3%), acute kidney injury (3.3%), and musculoskeletal pain (2.7%).
The most common adverse reactions (≥15%) were fatigue (39%), musculoskeletal pain (24%), constipation (21%), decreased appetite (19%), nausea (16%), peripheral edema (15%) and urinary tract infection (15%). The most common Grade 3 or 4 adverse reactions (≥3%) were fatigue, urinary tract infection, musculoskeletal pain, abdominal pain, dehydration, and general physical health deterioration.
Eight patients (4.4%) who were treated with IMFINZI experienced Grade 5 adverse events of cardiorespiratory arrest, general physical health deterioration, sepsis, ileus, pneumonitis, or immune-mediated hepatitis. Three additional patients were experiencing infection and disease progression at the time of death. IMFINZI was discontinued for adverse reactions in 3.3% of patients. Serious adverse reactions occurred in 46% of patients. The most frequent serious adverse reactions (>2%) were acute kidney injury (4.9%), urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver injury (3.3%), general physical health deterioration (3.3%), sepsis, abdominal pain, pyrexia/tumor associated fever (2.7% each).
Immune-mediated adverse reactions requiring systemic corticosteroids or hormone replacement therapy occurred in 8
