Sections or subsections omitted from the full prescribing information are not listed.ĭetermine total number of vials required (see Table 1). FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS 1 INDICATIONS AND USAGE 2ĝOSAGE AND ADMINISTRATION 2.1ĝose 2.2 Reconstitution 2.3Ědministration 2.4 Restarting Anticoagulant Therapy 3ĝOSAGE FORMS AND STRENGTHS 4ĜONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic and Ischemic Risks 5.2 Re-elevation or Incomplete Reversal of Anti-FXa Activity 6ĚDVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Immunogenicity 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11ĝESCRIPTION 12ĜLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Ĝarcinogenesis, Mutagenesis, Impairment of Fertility 14ĜLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION

Andexxa prescribing information