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SAVAYSA Highlights.pdf

206316lbl.pdf

🔗 Source: accessdata.fda.gov

📊 Size: 1.41 MB

👤 Author: FDA

⬇️ Downloads: 118

Summary

SAVAYSA (edoxaban) is indicated to reduce stroke and systemic embolism risk in nonvalvular atrial fibrillation (NVAF) patients and to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). It has warnings for reduced efficacy in NVAF patients with creatinine clearance >95 mL/min, premature discontinuation increasing ischemic event risk, and spinal/epidural hematoma. Dosage is 60 mg once daily for NVAF and DVT/PE, with reductions for renal impairment. Contraindications include active pathological bleeding, and precautions include bleeding risk, mechanical heart valves, and spinal/epidural anesthesia. Adverse reactions include bleeding, anemia, and rash. Drug interactions involve anticoagulants, rifampin, and P-gp inhibitors. Use in specific populations requires consideration of nursing mothers, renal impairment, and hepatic impairment.

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Description

SAVAYSA (edoxaban) is indicated to reduce stroke and systemic embolism risk in nonvalvular atrial fibrillation (NVAF) patients and to treat deep vein...

Technical Information

File Format: PDF
File Size: 1.41 MB
Pages: 32
Language: EN
Author: FDA
Total Downloads: 118
Last Updated: 1 month ago

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