Bleeding Risk
Savaysa increases the risk of bleeding because it reduces the blood’s ability to clot.
Bleeding can sometimes be serious or life-threatening. Tell your healthcare provider if you have a history of bleeding problems or if you take other medications that can increase bleeding risk.
These may include:
- Aspirin
- Other antiplatelet medications
- Other anticoagulants
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Certain antidepressants, including SSRIs and SNRIs
Seek medical attention if you develop unusual or severe bleeding, black or bloody stools, vomiting or coughing up blood, severe headache, unexplained weakness, or bleeding that does not stop.
Do Not Stop Savaysa Suddenly
Do not stop Savaysa without speaking with your healthcare provider unless you are experiencing a medical emergency involving serious bleeding.
Stopping Savaysa too early without another appropriate anticoagulant can increase the risk of stroke or other blood-clotting events.
If Savaysa needs to be discontinued, your healthcare provider may recommend another anticoagulant to maintain protection against blood clots.
Kidney Problems
Kidney function affects how Savaysa is removed from the body.
About half of edoxaban clearance occurs through the kidneys, so reduced kidney function can increase Savaysa levels and raise the risk of bleeding.
For patients with a creatinine clearance of 15 to 50 mL/min, a lower dose may be required. Savaysa is generally not recommended when creatinine clearance is below 15 mL/min.
High Kidney Function in Atrial Fibrillation
For patients taking Savaysa for nonvalvular atrial fibrillation, kidney function that is too high can also be important.
Savaysa is not recommended when creatinine clearance is greater than 95 mL/min because it may be less effective at preventing ischemic stroke in these patients.
Liver Problems
Tell your healthcare provider if you have liver disease.
Savaysa is not recommended in patients with moderate or severe liver impairment, because these patients may already have abnormalities in blood clotting.
No dose reduction is generally required for mild liver impairment.
Surgery and Medical Procedures
Tell your surgeon, dentist, or other healthcare provider that you take Savaysa before having surgery or an invasive procedure.
Because Savaysa increases bleeding risk, it may need to be temporarily stopped before certain procedures.
Do not stop it on your own. Your healthcare provider will tell you when to stop and when to restart treatment.
Spinal or Epidural Procedures
Patients taking Savaysa who receive spinal or epidural anesthesia or undergo a spinal puncture may be at risk of developing a spinal or epidural hematoma.
This collection of blood around the spinal cord can cause long-term or permanent paralysis.
Seek immediate medical attention if you develop back pain, numbness, tingling, muscle weakness, or loss of bladder or bowel control after a spinal procedure.
Drug Interactions
Savaysa can interact with other medications.
Some drugs can increase bleeding risk, while others may reduce the effectiveness of Savaysa.
Tell your healthcare provider about all prescription medications, over-the-counter products, vitamins, supplements, and herbal products you use.
Do not start or stop another medication without checking with your healthcare provider or pharmacist.
Alcohol
Heavy alcohol use can increase the risk of bleeding and may also increase the chance of falls or injuries while taking an anticoagulant.
It is best to discuss alcohol use with your healthcare provider, especially if you drink regularly or have liver problems.
Older Adults
Older adults can use Savaysa, and clinical studies found generally similar effectiveness and safety compared with younger adults.
However, bleeding risk can still increase with age because of changes in kidney function, other medical conditions, or the use of multiple medications.
Your healthcare provider may monitor kidney function and bleeding risk more closely.
Pregnancy
Tell your healthcare provider if you are pregnant, think you may be pregnant, or plan to become pregnant.
Anticoagulants can increase the risk of bleeding during pregnancy. Your healthcare provider will determine whether Savaysa is appropriate based on your need for anticoagulation and your individual risks.
Do not stop Savaysa on your own if you become pregnant.
Breastfeeding
Breastfeeding is not recommended during Savaysa treatment.
It is not known whether edoxaban passes into human breast milk, but because serious bleeding could potentially occur in a nursing infant, current prescribing information advises against breastfeeding while taking Savaysa.
Allergic Reactions
Seek urgent medical attention if you develop signs of a serious allergic reaction, such as:
- Hives
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing
- Severe rash
Regular Monitoring
Savaysa does not usually require routine INR testing like warfarin.
However, your healthcare provider may periodically monitor:
- Kidney function
- Liver function
- Signs of bleeding
- Hemoglobin or blood counts when clinically needed
- Other medications that may interact with Savaysa
Regular follow-up helps make sure the dose remains safe and appropriate.
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