Xarelto

Xarelto 20 mg

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Xarelto

Generic Name: rivaroxaban
Brand Names: Xarelto

What is Xarelto?

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery.

Xarelto is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

Xarelto may also be used for purposes not listed in this medication guide.

Important information

You should not use Xarelto if you have an artificial heart valve, or if you have active or uncontrolled bleeding.

Xarelto can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Do not stop taking Xarelto without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Before taking this medicine

You should not use Xarelto if you are allergic to rivaroxaban, or if you have:

  • an artificial heart valve; or
  • active or uncontrolled bleeding.

Xarelto can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if you have:

  • you have a genetic spinal defect;
  • you have a spinal catheter in place;
  • you have a history of spinal surgery or repeated spinal taps;
  • you have recently had a spinal tap or epidural anesthesia;
  • you are taking an NSAID — Advil, Aleve, Motrin, and others; or
  • you are using other medicines to treat or prevent blood clots.

Xarelto may cause you to bleed more easily, especially if you have:

  • a bleeding disorder that is inherited or caused by disease;
  • hemorrhagic stroke;
  • uncontrolled high blood pressure;
  • stomach or intestinal bleeding or ulcer; or
  • if you take certain medicines such as aspirin, heparin, warfarin (Coumadin, Jantoven), or clopidogrel (Plavix).

To make sure you can safely take Xarelto, tell your doctor if you have kidney or liver disease.

FDA pregnancy category C. It is not known whether Xarelto will harm an unborn baby. However, this medicine could cause bleeding complications during childbirth. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether rivaroxaban passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Xarelto.

How should I take rivaroxaban?

Take Xarelto exactly as prescribed by your doctor. Xarelto is taken either once per day or two times per day, depending on the reason you are using this medication. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

For atrial fibrillation: Take the Xarelto 15-milligram or 20-milligram tablet with your evening meal.

For hip or knee replacement surgery: You may take the Xarelto 10-milligram tablet with or without food.

Tell your doctor if you have trouble swallowing a Xarelto tablet.

Tell any doctor who treats you that you are using Xarelto. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using this medicine for a short time.

Use Xarelto regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not change your dose or stop taking this medication without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take Xarelto 1 time each day: Take the missed dose as soon as you remember. Take your next dose the following day and stay on your once-daily schedule. Do not take extra medicine to make up the missed dose.

If you take Xarelto 2 times each day: Take the missed dose as soon as you remember. You may take 2 doses at the same time to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause excessive bleeding.

What should I avoid?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Xarelto side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Xarelto: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
  • pain, swelling, or drainage from a wound or where a needle was injected in your skin;
  • bleeding from wounds or needle injections, any bleeding that will not stop;
  • headache, dizziness, weakness, feeling like you might pass out;
  • urine that looks red, pink, or brown; or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Xarelto side effects may include:

  • muscle pain;
  • itching; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Xarelto dosing information

Usual Adult Dose of Xarelto for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery:

Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery:
10 mg orally once a day starting 6 to 10 hours after surgery.

Duration of therapy is 35 days for hip replacement surgery and 12 days for knee replacement surgery.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery:

Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery:
10 mg orally once a day starting 6 to 10 hours after surgery.

Duration of therapy is 35 days for hip replacement surgery and 12 days for knee replacement surgery.

Usual Adult Dose for Atrial Fibrillation:

Nonvalvular Atrial Fibrillation:
20 mg orally, once daily with the evening meal.

Usual Adult Dose of Xarelto for Deep Vein Thrombosis:

Treatment of DVT and PE:
Initial dose: 15 mg orally twice daily with food, for first 21 days.
Maintenance dose: 20 mg orally once daily with food, for remaining treatment.

Usual Adult Dose for Pulmonary Embolism:

Treatment of DVT and PE:
Initial dose: 15 mg orally twice daily with food, for first 21 days.
Maintenance dose: 20 mg orally once daily with food, for remaining treatment.

Usual Adult Dose for Deep Vein Thrombosis — Recurrent Event:

Reduction in the Risk of Recurrence of DVT and of PE:
20 mg orally once daily with food.

Usual Adult Dose of Xarelto for Pulmonary Embolism — Recurrent Event:

Reduction in the Risk of Recurrence of DVT and of PE:
20 mg orally once daily with food.

What other drugs will affect Xarelto?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Xarelto, especially:

  • rifampin;
  • St. John’s wort;
  • antifungal medication—itraconazole or ketoconazole;
  • HIV medication—indinavir, lopinavir, ritonavir; or
  • seizure medication—carbamazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with Xarelto, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide

It is possible that some side effects of Xarelto may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rivaroxaban: oral tablet

As well as its needed effects, rivaroxaban (the active ingredient contained in Xarelto) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rivaroxaban, check with your doctor immediately:

More common

  • Back pain
  • bleeding gums
  • bloody stools
  • bowel or bladder dysfunction
  • burning, crawling, itching, numbness, prickling, «pins and needles», or tingling feelings
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • leg weakness
  • nosebleeds
  • numbness
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • vomiting of blood or material that looks like coffee grounds

Less common

  • Fainting
  • pain in the arms or legs
  • wound secretion

Rare

  • Burning while urinating
  • difficult or painful urination

Incidence not known

  • Abdominal or stomach pain or swelling
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • chills
  • clay-colored stools
  • cough or hoarseness
  • dark urine
  • diarrhea
  • fast or irregular heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives, itching, or skin rash
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe headache
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Some rivaroxaban side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common

  • Blisters
  • muscle spasm

For Healthcare Professionals

Applies to rivaroxaban: oral tablet

General

The most common adverse reactions were bleeding complications.[Ref]

The risk of bleeding may be increased in certain patient groups, including patients with uncontrolled severe arterial hypertension and/or concomitant treatment affecting hemostasis.[Ref]

Hematologic

Very common (10% or more): Any bleeding
Common (1% to 10%): Anemia (including postoperative anemia)
Uncommon (0.1% to 1%): Bleeding into a critical organ, bleeding that required reoperation, decreased hemoglobin, decrease in hemoglobin by 2 g/dL (20 g/L) or more, fatal bleeding, non-fatal non-critical organ bleeding, occult blood positive, thrombocythemia, transfusion of 2 or more units of whole blood or packed red blood cells (including extra-surgical site bleeding),
Postmarketing reports: Agranulocytosis[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dyspepsia, gastrointestinal bleeding, gastrointestinal hemorrhage (including rectal hemorrhage), gingival bleeding, nausea, toothache, upper abdominal pain, vomiting
Uncommon (0.1% to 1%): Dry mouth, gastric ulcer hemorrhage, hematochezia, hemorrhagic gastritis, hemorrhoidal hemorrhage, lip hemorrhage, lower abdominal pain, melena, mouth hemorrhage, tongue hemorrhage
Rare (less than 0.1%): Retroperitoneal bleeding[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, syncope
Uncommon (0.1% to 1%): Cerebral and intracranial hemorrhage
Rare (0.01% to 0.1%): Cerebellar hemorrhage, fatal intracranial bleeding, hemorrhagic transformation stroke
Frequency not reported: Intraspinal bleeding, spinal/epidural hematoma
Postmarketing reports: Hemiparesis, subdural hematoma[Ref]

Cardiovascular

Following study drug discontinuation in the ROCKET AF trial, cases of stroke were reported in during the transition from rivaroxaban (the active ingredient contained in Xarelto) to warfarin in nonvalvular atrial fibrillation patients.[Ref]

Common (1% to 10%): Deep vein thrombosis, hematoma, hypertension, hypotension (include procedural hypotension), peripheral edema, tachycardia
Rare (less than 0.1%): Vascular pseudoaneurysm
Frequency not reported: Pericardial and intra-articular bleeding, symptoms of cardiac ischemia such as chest pain or angina pectoris (as a consequence of anemia)[Ref]

Hepatic

Common (1% to 10%): Increase in transaminases
Uncommon (0.1% to 1%): Abnormal hepatic function, increased bilirubin, increased blood alkaline phosphatase, increased gamma glutamyltransferase (GGT)
Rare (less than 0.1%): Increased conjugated bilirubin (with or without concomitant ALT increase), jaundice
Postmarketing reports: Cholestasis, cytolytic hepatitis[Ref]

Renal

Common (1% to 10%): Renal impairment (including increased blood creatinine and blood urea)
Uncommon (0.1% to 1%): Decreased creatinine renal clearance
Frequency not reported: Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, anaphylactic shock, hypersensitivity[Ref]

Dermatologic

Common (1% to 10%): Blister, contusion, cutaneous and subcutaneous hemorrhage, ecchymosis, pruritus (including uncommon cases of generalized pruritus), rash, wound hemorrhage, wound secretion
Uncommon (0.1% to 1%): Allergic dermatitis, urticaria
Postmarketing reports: Angioedema, Stevens-Johnson syndrome[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urogenital tract hemorrhage (including hematuria and menorrhagia), vaginal hemorrhage
Uncommon (0.1% to 1%): Urinary tract infection
Rare (0.01% to 0.1%): Menometrorrhagia, metrorrhagia[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, increased amylase, increased LDH, increased lipase
Rare (less than 0.1%): Localized edema[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, increased muscle tone and cramping, muscle spasm, osteoarthritis, pain in extremity
Uncommon (0.1% to 1%): Hemarthrosis
Rare (less than 0.1%): Muscle hemorrhage
Frequency not reported: Intramuscular bleeding with compartment syndrome[Ref]

Ocular

Common (1% to 10%): Eye hemorrhage (including conjunctival hemorrhage)
Uncommon (0.1% to 1%): Vitreous hemorrhage
Rare (less than 0.1%): Intraocular bleeding[Ref]

Psychiatric

Common (1% to 10%): Anxiety reaction, sleep disorders[Ref]

Respiratory

Common (1% to 10%): Dyspnea, epistaxis, hemoptysis, oropharyngeal pain, sinusitis
Frequency not reported: Pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis[Ref]

Other

Common (1% to 10%): Decreased general strength and energy (including fatigue and asthenia), fever
Uncommon (0.1% to 1%): Feeling unwell (including malaise

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