Generic Name: edoxaban (e-DOX-a-ban)
Brand Name: Savaysa
Savaysa should not be used if your kidneys work well. It may not work as well to prevent stroke in people whose kidneys work well. You may need to take a different anticoagulant if your kidneys work well. Discuss any questions or concerns with your doctor.
Do not stop taking Savaysa without checking with your doctor. This may increase the risk of developing a blood clot, including stroke in certain patients. If you need to stop taking Savaysa, follow your doctor's directions carefully.
Tell your doctor you use Savaysa before you have any type of spinal or epidural procedure. Patients who have these procedures while they use Savaysa are at risk of serious bleeding problems on or near the spine. This could result in long-term or permanent paralysis.
The risk is increased in patients who have a certain type of epidural catheter. It is also increased in patients with a history of traumatic or repeated epidural or spinal puncture, a deformed spine, or spinal surgery. It is also increased in patients who use medicines that may affect blood clotting, such as other anticoagulants (eg, warfarin), aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen).
If you have a spinal or epidural procedure while you use Savaysa, tell your doctor at once if you notice any symptoms of nerve problems (eg, back pain, numbness [especially in the legs and feet], tingling, muscle weakness, paralysis, loss of bowel or bladder control).
Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of Savaysa and your procedure. Discuss any questions or concerns with your doctor.
Savaysa is used for:
Treating blood clots in certain patients. It is also used to reduce the risk of stroke and serious blood clots in certain patients with atrial fibrillation. It may also be used for other conditions as determined by your doctor.
Savaysa is a factor Xa inhibitor. It works by blocking the formation of blood clots.
Do NOT use Savaysa if:
- you are allergic to any ingredient in Savaysa
- you have active bleeding, normal kidney function, certain type of heart valve problem (moderate to severe mitral stenosis), or an artificial heart valve
- you have severe kidney problems or moderate to severe liver problems
- you are taking rifampin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Savaysa:
Some medical conditions may interact with Savaysa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney or liver problems
- if you weigh 132 lb (60 kg) or less
- If you have heart valve problems, a history of bleeding problems, or have an increased risk of bleeding
- if you have recently had or are scheduled to have certain procedures (eg, surgery, including brain, spine, or eye surgery; dental procedures; a spinal or epidural procedure)
Some MEDICINES MAY INTERACT with Savaysa. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abciximab, alteplase, other anticoagulants (eg, enoxaparin, heparin, warfarin), aspirin, bivalirudin, dabigatran, desirudin, eptifibatide, NSAIDs (eg, ibuprofen, ketorolac), platelet inhibitors (eg, clopidogrel, prasugrel, ticlopidine), or tirofiban because the risk of bleeding may be increased
- Rifampin because it may decrease Savaysa's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Savaysa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Savaysa:
Use Savaysa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Savaysa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Savaysa refilled.
- Take Savaysa by mouth with or without food.
- Take as you have been told, even if you feel well.
- To gain the most benefit, do not miss taking doses.
- If you miss a dose of Savaysa, take it as soon as you remember on the same day then go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Savaysa.
Important safety information:
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can.
- Tell your doctor or dentist that you take Savaysa before you receive any medical or dental care, emergency care, or surgery. Savaysa may need to be stopped before certain types of surgery, as directed by your doctor. If Savaysa is stopped, your doctor will tell you when to start taking Savaysa again after your surgery or procedure.
- Savaysa increases the risk of bleeding. This can cause serious and sometimes fatal bleeding. Call your doctor right away if you have symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; or any bleeding that is severe or that you cannot stop).
- Call your doctor right away if you fall or injure yourself, especially if you hit your head. Talk with your doctor even if you feel fine.
- Lab tests may be performed while you use Savaysa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: It is not known if Savaysa can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Savaysa while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Savaysa.
Possible side effects of Savaysa:
All medicines may cause side effects, but many people have no, or minor, side effects. If you have any side effects that continue or become bothersome, check with your doctor. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); symptoms of anemia (eg, unusual paleness, unusual tiredness or weakness); symptoms of bleeding in the brain (eg, sudden, severe headache; one-sided weakness; vision problems; slurred speech; confusion).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Savaysa:
Store Savaysa at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Savaysa out of the reach of children and away from pets.
- If you have any questions about Savaysa, please talk with your doctor, pharmacist, or other health care provider.
- Savaysa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Savaysa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Savaysa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Savaysa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Savaysa.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.