OBJECTIVE: To probe into the rationality and safety evaluation of clinical application of nivolumab injection. METHODS: Data of patients with nivolumab injection in the Fifth Medical Center of Chinese PLA General Hospital（South Hospital Area） from Jan. 2017 to Jun. 2020 were collected. According to drug instructions and latest guidelines

the rationality of clinical application of nivolumab injection was analyzed and evaluated

and the occurrence of adverse drug reactions was observed. RESULTS: From Jan. 2017 to Jun. 2020

a total of 60 patients in this hospital received nivolumab injection for 291 case-times

with an average treatment duration of 4.85 cycles per capita. A total of 49 cases（81.67%） met the indications in the drug instructions or recommendations of guidelines. The usage and dosage of nivolumab injection were basically rational. The incidence of adverse drug reactions was 40.00%（24/60）

most of which were grade 1 to grade 2

and could be improved without treatment or with symptomatic treatment. There were 8 cases of severe adverse drug reactions（13.33%）

including 4 cases（6.67%） of immune-related pneumonia. CONCLUSIONS: The application of nivolumab injection in this hospital basically follows the indications of drug instructions or recommendations of guidelines

but there are still cases of off-label indications in the domestic drug instructions. Clinical application should be noted in accordance with hospital regulations for filing and implementing informed consent. The incidence of severe adverse drug reactions of nivolumab injection is relatively high

especially immune-related pneumonia

which may be related to the high proportion of lung cancer patients

and may also be related to drug combination. The incidence of immune pneumonia has been underestimated in previous clinical studies and needs to be monitored during clinical application.