TABLE 3.
Approved contraindications for fondaparinux in different countries or regions.
| Contraindications | |
|---|---|
| China NMPA | ①Patients known to have hypersensitivity to fondaparinux sodium or any excipient in the formulation; | 
| ②Patients with clinically significant active bleeding; | |
| ③Patients with acute bacterial endocarditis; | |
| ④Patients with severe renal impairment, defined as a creatinine clearance <20 mL/min | |
| Europe EMA | ①Patients with severe renal impairment (creatinine clearance <30 mL/min); | 
| ②Patients with body weight <50 kg; | |
| ③Patients with active major bleeding, bacterial endocarditis; | |
| ④patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium; | |
| ⑤patients with known hypersensitivity to fondaparinux sodium | |
| US FDA | ①Patients with severe renal impairment (creatinine clearance <30 mL/min); | 
| ②Patients with active major bleeding; | |
| ③Patients with bacterial endocarditis; | |
| ④Patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the ⑤presence of fondaparinux sodium; | |
| ⑥Patients with body weight <50 kg (VTE prophylaxis only); | |
| ⑦Patients with a history of severe hypersensitivity reactions to fondaparinux sodium (e.g., angioedema, anaphylactoid/anaphylactic reaction) |