Brand Name

Savaysa

Generic Name
edoxaban tosylate
View Brand Information
FDA approval date: January 12, 2015
Classification: Factor Xa Inhibitor
Form: Tablet

What is Savaysa (edoxaban tosylate)?

Blood clots are a serious health concern that can lead to life-threatening events like strokes, heart attacks, or pulmonary embolisms. For many people living with conditions that increase clot risk, maintaining healthy blood flow isn’t just about comfort—it’s about survival. Savaysa (edoxaban tosylate) is a medication that helps prevent these dangerous clots from forming, offering patients protection and peace of mind in their daily lives. 

Savaysa is an oral anticoagulant, or “blood thinner,” belonging to a class of drugs known as factor Xa inhibitors. It is used to reduce the risk of stroke and blood clots in people with certain types of irregular heartbeats and to treat or prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). Approved by the U.S. Food and Drug Administration (FDA) in 2015, Savaysa is part of a newer generation of anticoagulants that offer a simpler, more predictable alternative to traditional therapies like warfarin. 

What does Savaysa do? 

Savaysa helps prevent the formation of harmful blood clots in the veins and arteries. It is prescribed for adults with: 

  • Nonvalvular atrial fibrillation (AFib): an irregular heart rhythm that can cause blood to pool and clot in the heart, increasing the risk of stroke. 
     
  • Deep vein thrombosis (DVT): a blood clot that forms in deep veins, typically in the legs. 
     
  • Pulmonary embolism (PE): a clot that travels to the lungs, which can be life-threatening. 

By reducing the blood’s tendency to clot, Savaysa lowers the risk of stroke, recurrent DVT, and PE, helping patients lead safer, more active lives. 

In clinical studies, Savaysa was shown to be as effective as warfarin in preventing strokes in patients with atrial fibrillation, with a lower risk of major bleeding in some cases (FDA, 2024). This makes it a strong and reliable option for long-term anticoagulation therapy. 

How does Savaysa work? 

Savaysa contains edoxaban, a direct factor Xa inhibitor. Factor Xa is a key enzyme in the body’s natural clotting process, it helps produce thrombin, which in turn helps form blood clots. By blocking factor Xa, Savaysa slows the formation of thrombin, preventing new clots from forming and stopping existing ones from getting larger. 

This mechanism provides a more targeted and consistent anticoagulant effect than older drugs like warfarin, which require frequent blood testing and dietary restrictions. 

From a clinical perspective, this is significant because it allows patients to maintain stable anticoagulation without constant monitoring, helping reduce anxiety and improving adherence to treatment. However, doctors still monitor kidney function and other health parameters to ensure the medication remains safe and effective over time. 

Savaysa side effects 

Like all anticoagulants, Savaysa can increase the risk of bleeding, since it works by reducing the blood’s ability to clot. While most side effects are mild, it’s important for patients and caregivers to recognize the signs of more serious complications. 

Common side effects may include: 

  • Easy bruising or prolonged bleeding from minor cuts 
     
  • Nosebleeds 
     
  • Mild anemia (fatigue or pale skin) 
     
  • Upset stomach or nausea 

Serious side effects (seek medical help immediately): 

  • Unexpected or severe bleeding (such as vomiting blood or passing black, tarry stools) 
     
  • Severe headache, dizziness, or weakness (possible internal bleeding) 
     
  • Signs of allergic reaction such as rash, swelling, or difficulty breathing 

Because Savaysa affects blood clotting, it should not be used in patients with active bleeding, mechanical heart valves, or certain types of severe kidney disease. 

Patients should inform their doctor if they have liver problems, a history of bleeding disorders, or if they take other medications that affect clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or other anticoagulants. 

Reassuringly, for most patients, Savaysa’s side effects are manageable under proper medical supervision. Its predictable dosing and lower dietary impact make it easier to live a normal, active lifestyle while maintaining effective stroke and clot prevention. 

Savaysa dosage 

Savaysa is an oral tablet taken once daily, with the dose adjusted based on kidney function, body weight, and the condition treated. For atrial fibrillation, excellent kidney function may reduce effectiveness, requiring an alternative. It also treats DVT and PE, often following injectable anticoagulants. 

Doctors regularly check kidney and liver function, especially in older adults or those with chronic conditions, to ensure proper medication processing and reduce bleeding risks. Patients should never abruptly stop Savaysa without consulting a healthcare provider, as this can increase the risk of clots or stroke. 

Does Savaysa have a generic version? 

As of 2025, Savaysa (edoxaban tosylate) does not yet have a generic version approved by the U.S. FDA. It is currently available only as the brand-name product manufactured by Daiichi Sankyo, Inc. However, international versions may exist in other markets. 

A generic version of Savaysa must have the same active ingredient, strength, safety, and effectiveness. Patients can inquire about financial aid for brand-name Savaysa. Savaysa, Eliquis (apixaban), and Xarelto (rivaroxaban) are modern anticoagulants, and doctors may consider these options based on patient profiles and budgets. 

Conclusion 

Savaysa is a modern, effective oral anticoagulant designed to reduce the risk of stroke and blood clots in people with atrial fibrillation and to treat or prevent DVT and PE. By directly inhibiting factor Xa, it provides predictable and steady blood thinning without the dietary limitations or frequent monitoring required by older medications like warfarin. 

Savaysa, a convenient and effective blood thinner, manages bleeding risks under professional care. Regular checkups, open communication about side effects, and adherence to dosing ensure successful treatment, offering patients greater confidence and control against clot-related complications. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Savaysa (edoxaban) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Edoxaban (oral route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Edoxaban: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Anticoagulants and blood clot prevention overview. Retrieved from https://www.nih.gov 

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial

Summary: Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial

Summary: The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatel...

Brand Information

SAVAYSA (EDOXABAN TOSYLATE)
1DOSAGE FORMS AND STRENGTHS
  • 60 mg, yellow round shaped, film-coated tablets, debossed with DSC L60 on one side
  • 30 mg, pink round shaped, film-coated tablets, debossed with DSC L30 on one side
  • 15 mg, orange round shaped, film-coated tablets, debossed with DSC L15 on one side
2CONTRAINDICATIONS
SAVAYSA is contraindicated in patients with:
  • Active pathological bleeding
3ADVERSE 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
  • Risk of Bleeding
  • Spinal/Epidural Anesthesia or Puncture
3.1Clinical 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 including 11,530 patients exposed to SAVAYSA 60 mg and 7124 patients exposed to SAVAYSA 30 mg once daily
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of SAVAYSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: thrombocytopenia
Gastrointestinal disorders: abdominal pain
Immune system disorders: angioedema, hypersensitivity
Nervous system disorders: dizziness, headache
Renal and urinary disorders: anticoagulant-related nephropathy
Skin and subcutaneous tissue disorders: urticaria
4OVERDOSAGE
A specific reversal agent for edoxaban is not available. Overdose of SAVAYSA increases the risk of bleeding.
The following are not expected to reverse the anticoagulant effects of edoxaban: protamine sulfate, vitamin K, and tranexamic acid
Hemodialysis does not significantly contribute to edoxaban clearance
5DESCRIPTION
Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is
Chemical Structure
It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9.
SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).
6HOW SUPPLIED/STORAGE AND HANDLING
SAVAYSA (edoxaban) is supplied as round shaped, film-coated, non-scored tablets containing edoxaban tosylate equivalent to 60, 30 or 15 mg of SAVAYSA, packaged in bottles and blisters.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients of the following:
8PRINCIPAL DISPLAY PANEL - 30 mg Blister Pack Carton
NDC 65597-202-05
Savaysa
30 mg
Dispense with medication guide
Daiichi-Sankyo
Rx only
Principal Display Panel - 30 mg Blister Pack Carton
9PRINCIPAL DISPLAY PANEL - 60 mg Blister Pack Carton
NDC 65597-203-05
Savaysa
60 mg
Dispense with medication guide
Daiichi-Sankyo
Rx only
Principal Display Panel - 60 mg Blister Pack Carton