Savaysa (Edoxaban)

SAVAYSA comes as a tablet to take by mouth, typically once a day.

This medicine can be taken with or without food.

Your dose will depend on your medical condition and response to treatment.

Try to take SAVAYSA around the same time each day.

Follow the instructions on your prescription label carefully. Don't take more or less SAVAYSA than is recommended.

SAVAYSA Overdose

Symptoms of a SAVAYSA overdose may include:

• Unusual bruising or bleeding
• Bloody urine
• Black, bloody, or tarry stools
• Coughing up blood or a material that looks like coffee grounds

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of SAVAYSA

If you miss a dose of SAVAYSA, take it as soon as you remember on the same day.

But if it's the next day, skip the missed dose and continue with your regular medication schedule.

Don't take extra medicine to make up for a missed dose.

Common Side Effects of SAVAYSA

Tell your doctor if any of the following side effects become severe or don't go away:

• Tiredness or weakness
• Rash
• Mild dizziness

Serious Side Effects of SAVAYSA

Tell your doctor immediately if you experience any of the symptoms listed in the SAVAYSA Warnings section above, or the following serious side effects:

• Easy bruising
• Unusual bleeding or bleeding that won't stop, including nosebleeds and bleeding gums
• Heavy menstrual periods (in women)
• Pain, bruising, or weakness where a needle was injected in your skin
• Pink, brown, or red urine
• Black or bloody stools
• Coughing up blood, or vomit that looks like coffee grounds
• Severe headache
• Severe dizziness or feeling like you might pass out
• Pale skin
• Feeling lightheaded or short of breath
• Severe weakness
• Rapid heart rate
• Trouble concentrating
• Symptoms of anaphylaxis, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Don't suddenly stop using this medicine without first talking to your doctor. Continue to take SAVAYSA even if you feel well, and don't miss any doses.

If you need to stop treatment with SAVAYSA, your healthcare provider may prescribe another blood thinner to help prevent a stroke.

SAVAYSA contains another black box warning because it may cause a serious blood clot around your spinal cord if you have an epidural, spinal anesthesia, or a spinal puncture while taking it.

This blood clot can lead to long-term or permanent paralysis.

Tell your doctor if you currently have, or have ever had:

• Epidural catheters
• Spinal punctures
• A spinal deformity
• Spinal surgery

It's also important to let your healthcare provider know if you're taking any drugs that may affect how your blood clots, including:

• Aggrastat (tirofiban)
• Agrylin (anagrelide)
• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen), Indocin or Tivorbex (indomethacin), ketoprofen, and Aleve, Anaprox, or Naprosyn (naproxen)
• Brilinta (ticagrelor)
• Coumadin or Jantoven (warfarin)
• Effient (prasugrel)
• Heparin
• Integrilin (eptifibatide)
• Persantine (dipyridamole)
• Plavix (clopidogrel)
• Pletal (cilostazol)
• Ticlopidine

Tell your doctor immediately if you experience any of the following symptoms while using SAVAYSA:

• Muscle weakness, especially in the legs or feet
• Numbness or tingling, especially in the legs
• Back pain
• Loss of control of your bladder or bowels

SAVAYSA contains an additional black box warning because it may not work as well in people with normal kidney function (compared with mildly impaired kidney function).

Your healthcare provider will check your kidneys before you start treatment with this medicine.

Don't take SAVAYSA if you have an artificial heart valve or active bleeding.

This drug may cause you to bleed or bruise more easily.

Try to avoid activities that increase your risk of bleeding or injury while using SAVAYSA. Call your doctor right away if you injure yourself — especially if you hit your head.

Let your healthcare provider know you're using this medicine before having any type of medical or dental procedure.

Before starting treatment with SAVAYSA, tell your doctor if you have, or have ever had:

• Kidney disease
• Liver disease
• A bleeding disorder
• Uncontrolled high blood pressure
• A stroke
• Allergies to to any medication

Also, let your doctor know if you weigh 132 pounds or less.

Keep all appointments with your doctor and laboratory during your treatment with SAVAYSA. Your healthcare provider will probably order frequent tests to check your body's response to this medicine.

SAVAYSA can be associated with a low red blood cell count or abnormal liver enzyme tests, and your doctor may wish to order additional tests.

Pregnancy and SAVAYSA

It's not known whether SAVAYSA could harm an unborn baby if taken during pregnancy.

But it may increase the risk of bleeding complications during childbirth.

Tell your doctor if you're pregnant, or might become pregnant, while using SAVAYSA.

It's also not known whether this drug passes into breast milk. Don't breastfeed a baby while taking SAVAYSA.

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the SAVAYSA Warnings section above, and the following:

• Cordarone or Pacerone (amiodarone)
• Lipitor, Caduet, or Liptruzet (atorvastatin)
• Gengraf, Neoral, or Sandimmune (cyclosporine)
• Lanoxin (digoxin)
• Multaq (dronedarone)
• E.E.S., E-Mycin, or Erythrocin (erythromycin)
• Nexium or Vimovo (esomeprazole)
• Nizoral (ketoconazole)
• Quinidine
• Rifadin, Rifamate, Rifater, or Rimactane (rifampin)
• Calan, Covera, Isoptin, Verelan, or Tarka (verapamil)