Savaysa

Savaysa is a prescription medication used to reduce the risks of stroke and dangerous blood clots in patients with atrial fibrillation (abnormal heart rhythm) that is not caused by a heart valve problem.

Savaysa also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for 5 to 10 days.

DVT is a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. A potentially deadly condition called PE results when a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow.

Savaysa belongs to a group of drugs called direct factor Xa inhibitors, which are anti-clotting medications. These work by blocking the action of a natural substance that helps blood clots to form.

Savaysa comes in tablet form and is taken once daily.

Common side effects include bleeding and anemia.

Savaysa is a prescription medication used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Savaysa is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for 5 to 10 days.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Daiichi Sankyo, Inc.

Serious side effects have been reported with Savaysa. See the “Savaysa Precautions” section.

Common side effects of Savaysa include:

• bleeding
• anemia
• rash
• abnormal liver function tests

This is not a complete list of Savaysa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other anti-clotting drugs or platelet aggregattion inhibitors such as warfarin (Coumadin, Jantoven) or clopidogrel (Plavix), ticlopidine (Ticlid), or cilostazol (Pletal)
• aspirin or other non-steroidal antiinflammatory drugs (NSAIDs)such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• rifampin

This is not a complete list of Savaysa drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Savaysa, including:

• major bleeding
• stroke

Do not take Savaysa if you:

• are allergic to Savaysa or to any of its ingredients
• have active bleeding
• have a mechanical heart valve and have narrowing of the mitral valve

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Savaysa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Savaysa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Savaysa or to any of its ingredients
• have liver problems
• have kidney problems
• have ever had bleeding problems
• have a mechanical heart valve
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Savaysa falls into category C.There are no well-controlled studies that have been done in pregnant women. Savaysa should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Savaysa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Savaysa.

Take Savaysa exactly as prescribed.

Savaysa comes in tablet form and is taken once daily. It can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Savaysa at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The recommended dose of Savaysa is 60 mg once daily.

If you take too much Savaysa, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Savaysa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Savaysa at room temperature.
• Keep this and all medications out of the reach of children.

• REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN
  • SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF- TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once-daily compared to patients treated with warfarin. In these patients another anticoagulant should be used.
• PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS
  • Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance in the Prescribing Information.
• SPINAL/EPIDURAL HEMATOMA
  • Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
  • Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery.
  • Optimal timing between the administration of SAVAYSA and neuraxial procedures is not known.
  • Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.