Xarelto

Xarelto is a prescription medication used to prevent certain types of blood clots and strokes. Xarelto can be used in people who are having hip or knee replacement surgery, and for people with an irregular heart rhythm.

Xarelto , a "blood thinner", belongs to a group of drugs called factor Xa inhibitors. Factor Xa is an enzyme required for blood to clot. Xarelto inhibits factor Xa, slowing down blood clot formation.

This medication comes in tablet form and is usually taken once daily, with or without food. For people taking it for atrial fibrillation (irregular heart rhythm), Xarelto is taken once daily with the evening meal.

Common side effects include itching, muscle spasms, and bleeding.

Xarelto is a prescription medicine used in adults to:

• reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body.
• reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.
• treat and reduce the recurrence of blood clots in the legs [deep vein thrombosis (DVT)].
• treat and reduce the recurrence of blood clots in the lungs [pulmonary embolism (PE)].
• reduce the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

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

• Janssen Pharmaceuticals, Inc.

Xarelto can cause bleeding, which can be serious, and rarely may lead to death. See "Drug Precautions".

Xarelto may cause other side effects. Discuss any side effects with your doctor.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way Xarelto works. Certain medicines may increase your risk of bleeding. 

Especially tell your doctor if you take:

• ketoconazole (Nizoral)
• itraconazole (Onmel, Sporanox)
• ritonavir (Norvir)
• lopinavir/ritonavir (Kaletra)
• indinavir (Crixivan)
• carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
• phenytoin (Dilantin-125, Dilantin)
• phenobarbital (Solfoton)
• rifampin (Rifater, Rifamate, Rimactane, Rifadin)
• St. John's wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

• People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Xarelto lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking Xarelto, you may have increased risk of forming a clot in your blood. Do not stop taking Xarelto without talking to the doctor who prescribes it for you. Stopping Xarelto  increases your risk of having a stroke. If you have to stop taking Xarelto, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
• Xarelto can cause bleeding which can be serious, and rarely may lead to death. This is because Xarelto is a blood thinner medicine that reduces blood clotting. While you take Xarelto you are likely to bruise more easily and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take Xarelto and take other medicines that increase your risk of bleeding.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

• unexpected bleeding or bleeding that lasts a long time
• nose bleeds that happen often
• unusual bleeding from the gums
• menstrual bleeding that is heavier than normal or vaginal bleeding
• bleeding that is severe or you cannot control
• red, pink or brown urine
• bright red or black stools (looks like tar)
• cough up blood or blood clots
• vomit blood or your vomit looks like "coffee grounds"
• headaches, feeling dizzy or weak
• pain, swelling, or new drainage at wound sites

Do not take Xarelto if you:

• currently have certain types of abnormal bleeding. Talk to your doctor before taking Xarelto if you currently have unusual bleeding.
• are allergic to Xarelto or any of the ingredients in it.

Grapefruit and grapefruit juice may interact with Xarelto and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take Xarelto, tell your doctor if you:

• have ever had bleeding problems
• have liver or kidney problems
• have any other medical condition
• are pregnant or planning to become pregnant. It is not known if Xarelto will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Xarelto passes into your breast milk. You and your doctor should decide if you will take Xarelto or breastfeed.

Tell all of your doctors and dentists that you are taking Xarelto. They should talk to the doctor who prescribed Xarelto for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way Xarelto works. Certain medicines may increase your risk of bleeding.

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.

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

It is not known if Xarelto 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 Xarelto.

• Take Xarelto exactly as prescribed by your doctor. Do not change your dose or stop taking Xarelto unless your doctor tells you to.
• For people who have:
  • atrial fibrillation: Take Xarelto 1 time a day with your evening meal. Stopping Xarelto may increase your risk of having a stroke or forming blood clots in other parts of your body.
  • hip or knee replacement surgery: Take Xarelto 1 time a day with or without food.
• Your doctor will decide how long you should take Xarelto. Do not stop taking Xarelto without talking with your doctor first.
• Your doctor may stop Xarelto for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking Xarelto again after your surgery or procedure.
• Do not run out of Xarelto. Refill your prescription of Xarelto before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have Xarelto available to avoid missing any doses.
• If you miss a dose of Xarelto, take it as soon as you remember on the same day.
• If you take too much Xarelto, go to the nearest hospital emergency room or call your doctor right away.

Take Xarelto exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose of Xarelto is individualized. Your doctor will determine the best dose and length of therapy for you based on the reason you require the medicine, and how well your kidneys function, other medicines you are taking, and other factors.

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

• Store Xarelto at room temperature between 59° to 86°F (15° to 30° C).
• Keep Xarelto and all medicines out of the reach of children.

WARNINGS: (A) DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA

A. DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION

Discontinuing Xarelto places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following Xarelto discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation with Xarelto must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant.

B. SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas have occurred in patients treated with Xarelto 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 non-steroidal 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

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 for thromboprophylaxis.