SAVAYSA 60 mg/1
EDOXABAN TOSYLATE · TABLET, FILM COATED · Daiichi Sankyo Inc.
Savaysa (edoxaban tosylate) is an oral anticoagulant tablet used to help prevent blood clots and reduce the risk of stroke in patients with certain heart rhythm conditions, as well as to treat deep vein thrombosis and pulmonary embolism. It works by blocking certain clotting factors in the blood to prevent dangerous clots from forming.
Key Facts
- Brand Name
- SAVAYSA
- Generic Name
- EDOXABAN TOSYLATE
- NDC Code (Product)
65597-203- Manufacturer
- Daiichi Sankyo Inc.
- Strength
- 60 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA206316
- Marketing Start
- 01/12/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Limitation of Use for NVAF SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Studies (14.1) ] . 1.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism SAVAYSA is indicated for the treatment of deep vein thrombosis (D…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Treatment of NVAF: Assess CrCL before initiating therapy ( 2.1 ) The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min ( 2.1 ) Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min ( 2.1 ) Treatment of DVT and PE: The recommended dose is 60 mg once daily ( 2.2 ) Reduce dose to 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors ( 2.2 ) 2.1 Nonvalvular Atrial Fibrillation The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1) and Clinical Studies (14.1) ] . Assess creatinine clearance, as calculated using the Cockcroft-Gault equation Cockcroft-Gault CrCL = (140-age) × (weight in kg) × (0.85 if female) / (72 × creatinine in mg/dL). , before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min. Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min [see Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . 2.2 Treatment of Deep Vein Thrombosis an…
Contraindications
4 CONTRAINDICATIONS SAVAYSA is contraindicated in patients with: Active pathological bleeding [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] . Active pathological bleeding ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anticoagulants, Antiplatelets, Thrombolytics, and Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Avoid concomitant use due to increased risk of bleeding. ( 7.1 ) Rifampin: Avoid concomitant use ( 7.2 ) 7.1 Anticoagulants, Antiplatelets, Thrombolytics, and SSRIs/SNRIs Co-administration of anticoagulants, antiplatelet drugs, thrombolytics and SSRIs or SNRIs may increase the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with anticoagulants, aspirin, other platelet aggregation inhibitors, and/or NSAIDs [see Warnings and Precautions (5.3) ] . Long-term concomitant treatment with SAVAYSA and other anticoagulants is not recommended because of increased risk of bleeding [see Warnings and Precautions (5.3) ] . Short term co-administration may be needed for patients transitioning to or from SAVAYSA [see Dosage and Administration (2.4) ] . In clinical studies with SAVAYSA concomitant use of aspirin (low dose ≤ 100 mg/day) or thienopyridines, and NSAIDs was permitted and resulted in increased rates of Clinically Relevant Bleeding. Carefully monitor for blee…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation [see Warnings and Precautions (5.2) ] Risk of Bleeding [see Warnings and Precautions (5.3) ] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.4) ] Treatment of NVAF : The most common adverse reactions (≥ 5%) are bleeding and anemia ( 6.1 ) Treatment of DVT and PE : The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SAVAYSA was evaluated in the ENGAGE AF-TIMI 48, Hokusai VTE, and Hokusai VTE Cancer studies i…
Frequently Asked Questions
What is SAVAYSA used for?
Savaysa (edoxaban tosylate) is an oral anticoagulant tablet used to help prevent blood clots and reduce the risk of stroke in patients with certain heart rhythm conditions, as well as to treat deep vein thrombosis and pulmonary embolism. It works by blocking certain clotting factors in the blood to prevent dangerous clots from forming.
Is SAVAYSA a controlled substance?
SAVAYSA is not classified as a controlled substance by the DEA.
What is the generic name for SAVAYSA?
The generic name for SAVAYSA is EDOXABAN TOSYLATE. There are no other listed brand versions of EDOXABAN TOSYLATE.
What is the NDC code for SAVAYSA 60 mg/1?
The NDC (National Drug Code) for SAVAYSA 60 mg/1 is 65597-203, listed by Daiichi Sankyo Inc..
Other SAVAYSA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)