Analysis and suggestions on the selection of infusion sets for monoclonal antibody drugs based on package inserts
- VernacularTitle:基于药品说明书的单克隆抗体药物输液器具的选择分析与建议
- Author:
Zhuqing WANG
1
;
Danwei WU
1
;
Shuang REN
1
;
Yalin YANG
1
;
Wei ZHANG
1
Author Information
1. Dept. of Pharmacy，Beijing Jishuitan Hospital，Capital Medical University，Beijing 100035，China
- Publication Type:Journal Article
- Keywords:
monoclonal antibody;
infusion set;
filter;
material;
pore size;
package insert
- From:
China Pharmacy
2026;37(15):2035-2038
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To investigate the requirements for infusion sets specified in the package inserts of monoclonal antibody drugs commonly used for intravenous infusion in China， and to provide a reference for the rational selection of infusion sets for this class of drugs in clinical practice. METHODS The “Drug Query” section of the official website of the National Medical Products Administration， including the “Domestically Manufactured Drugs” and “Overseas Manufactured Drugs” databases， as well as the DXY “Yongyao Zhushou” database， were searched to collect the package inserts of monoclonal antibody drugs available on the domestic market as of November 2025 that had requirements for intravenous infusion sets. Relevant requirements for infusion set materials， filter pore size， and filter materials were extracted， classified， and analyzed. RESULTS A total of 55 monoclonal antibody drugs for intravenous infusion were included， comprising 45 anticancer drugs （81.82%）， 5 immunomodulatory drugs （9.09%）， and 5 drugs for other diseases （9.09%）. The package inserts of 44 drugs （80.00%） had clear requirements for the filter pore size of infusion sets， of which 36 drugs （65.45%） required a pore size of 0.2 μm or 0.22 μm. The package inserts of 16 drugs （29.09%） specified the filter material， all of which recommended polyethersulfone. The package inserts of 25 drugs （45.45%） specified the infusion set material， primarily polyvinyl chloride， polyethylene， or polypropylene. CONCLUSIONS The requirements for infusion sets vary among different monoclonal antibody drugs， with differences mainly concentrated in two aspects： material compatibility and filter pore size. In clinical practice， the selection should be based on the drug package inserts， following the principles of “compatibility first， appropriate filtration， and system integration”， and standardized management should be achieved through the development of quick-reference manuals specifically addressing the requirements for infusion sets and the integration of relevant requirements into the prescription review and dispensing systems.
