Savaysa

(Edoxaban Tosylate)

Savaysa contains edoxaban, an oral anticoagulant (factor Xa inhibitor) that works by reducing the blood’s ability to clot. By lowering the risk of clot formation, Savaysa helps protect against serious and potentially life-threatening events such as stroke, pulmonary embolism, and other thromboembolic complications.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Savaysa. However, the following is a synopsis of the general guidelines for the use of Savaysa:

• Savaysa is taken by mouth once daily, with or without food.
• Tablets should be swallowed whole with water.
• The dose is based on kidney function, body weight, and other medical conditions.
• For treatment of deep vein thrombosis or pulmonary embolism, Savaysa is usually started after at least 5 days of treatment with a parenteral anticoagulant such as heparin.
• If you miss a dose, take the missed dose as soon as you remember on the same day, then take your next dose at the regular time. Do not take two doses at once.
• Do not stop taking Savaysa without talking to your healthcare provider, as stopping suddenly can increase the risk of stroke or blood clots.

Some mild or common side effects of edoxaban seen in clinical trials include:

• Bruising and bleeding.
• Anemia or low red blood cell counts.
• Skin rash.

Some individuals may experience serious side effects while using Savaysa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe or uncontrolled bleeding.
• Blood in the urine or stools, or black, tarry stools.
• Coughing up blood or vomiting blood or material that looks like coffee grounds.
• Severe headache, dizziness, or weakness may be signs of a hemorrhagic stroke.
• Sudden back pain, numbness, or muscle weakness, especially after spinal puncture or epidural catheter use.
• Allergic reactions, including hives, swelling of the face or throat, or trouble breathing.

These are not all of the possible side effects of Savaysa. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Savaysa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney disease or reduced kidney function.
• Liver disease.
• A history of bleeding problems.
• Antiphospholipid syndrome.
• Mechanical heart valves or moderate to severe mitral stenosis.
• A history of spinal procedures or planned spinal puncture.
• Older adults and patients with low body weight may have an increased risk of bleeding and may require dose adjustments.

Boxed Warning

Savaysa has a boxed warning.

Savaysa should not be used in patients with nonvalvular atrial fibrillation who have a creatinine clearance (CrCl) greater than 95 mL/min, as it may be less effective in reducing the risk of stroke in these patients.

Discontinuing Savaysa increases the risk of stroke. If Savaysa must be stopped for any reason other than serious bleeding, another anticoagulant should be started to reduce the risk of thromboembolism.

Spinal or epidural hematomas may occur in patients treated with Savaysa who receive spinal anesthesia or undergo spinal puncture. These events may result in long-term or permanent paralysis.

Savaysa should not be used in patients with active bleeding. It is also not recommended for patients with mechanical heart valves or those with antiphospholipid syndrome, particularly those who are triple-positive for antibodies.

Savaysa begins working within a few hours after the first dose. Its anticoagulant effects are typically present on the same day of dosing. Because it acts quickly, consistent daily use is important to maintain protection against blood clots.

When Savaysa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen or naproxen increase the risk of bleeding.
• Antiplatelet agents may increase bleeding risk.
• Rifampin may reduce the effectiveness of Savaysa.
• Certain P-gp inhibitors or P-gp inducers, such as quinidine, verapamil, dronedarone, or cyclosporine, may increase edoxaban levels.
• Other anticoagulants increase the risk of major bleeding.
• Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs).
• Amiodarone.
• Apixaban.
• Azithromycin.
• Rivaroxaban.
• Dabigatran.

Savaysa is available as oral tablets in multiple strengths. The prescribed dose depends on kidney function, body weight, and the condition being treated.

If you are using another medicine to thin the blood (eg, heparin, warfarin, Coumadin, Jantoven), your doctor will give you very specific instructions about how to switch to edoxaban.

It should be stored at room temperature, away from the reach of children or pets.

Savaysa is manufactured by Daiichi Sankyo.

No. Savaysa is currently available only as a brand-name medication.

Do not stop taking Savaysa without speaking to your healthcare provider. Stopping treatment suddenly can increase the risk of stroke or blood clots. If Savaysa must be discontinued, your provider may prescribe another anticoagulant.

Savaysa is not generally recommended during pregnancy due to the risk of bleeding and potential harm to the unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. It is not known whether edoxaban passes into breast milk, and your healthcare provider will help determine the safest option.