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Off-label drug use （OLDU） is extremely common worldwide. However， if the safety of OLDU cannot be supported by sufficient evidence-based medicine， it will lead to legal disputes when it causes adverse events. OLDU should be considered with cautions especially for vulnerable populations， such as the elderly， children and pregnant women. In this article， according to off-lab contents and up-to-date guidelines， clinical trials and other evidence-based medicine at home and abroad， OLDU medication guidelines of immunotherapy drugs and COVID-19 antiviral drugs for COVID-19 therapy were collected and compiled. OLDU guidelines were formulated especially for the vulnerable populations， aiming to provide reference for clinical drug requirement and promote rational drug use.