Rivaroxaban

What is Rivaroxaban?

• Rivaroxaban (Xarelto) is a factor Xa inhibitor used in the prevention of stroke and venous embolism in patients with chronic atrial fibrillation, as well as treatment and prevention of deep venous thromboses and pulmonary embolism.

Rivaroxaban

Rivaroxaban ball-and-stick

Rivaroxaban (Xarelto®) tablets

What are the uses of this medicine?

Xarelto is a prescription medicine used to:

• reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. 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.
• treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
• reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months.
• help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

Xarelto is used with low dose aspirin to:

• reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral artery disease (a condition where the blood flow to the legs is reduced).

How does this medicine work?

• Rivaroxaban (riv" a rox' a ban) is a selective inhibitor of factor Xa, the rate controlling last step in the generation of thrombin, the final intermediate in blood coagulation.
• Inhibiting thrombin prevents the conversion of fibrinogen to fibrin and subsequent cross linking of fibrin monomers, platelet activation and amplification of coagulation.
• Rivaroxaban has been shown to be as effective as warfarin in preventing stroke and systemic embolization in patients with atrial fibrillation, and to decrease the risk of deep vein thrombosis and pulmonary embolism in patients undergoing surgery.
• Rivaroxaban is orally available and provides a reliable anticoagulant effect for which monitoring of INR is not needed.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• currently have certain types of abnormal bleeding.
• are allergic to rivaroxaban or any of the ingredients in Xarelto.

What drug interactions can this medicine cause?

• Avoid concomitant administration of Xarelto with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir).
• Xarelto should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk.
• Avoid concomitant use of Xarelto with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort)
• Avoid concurrent use of Xarelto with other anticoagulants (eg: enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID ) due to increased bleeding risk unless benefit outweighs risk.

Is this medicine FDA approved?

• Rivaroxaban was approved for use in the United States in 2011 and indications are for prevention of stroke and embolism in patients with chronic atrial fibrillation not related to valvular heart disease, as well as prevention and treatment of deep vein thrombosis and pulmonary embolism.

How should this medicine be used?

Recommended dosage: Nonvalvular Atrial Fibrillation:

• For patients with CrCl >50 mL/min: 20 mg orally, once daily with the evening meal
• For patients with CrCl ≤50 mL/min: 15 mg orally, once daily with the evening meal

Treatment of DVT(deep vein thrombosis) and/or PE(pulmonary embolism):

• 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment

Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE:

• 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment

Prophylaxis of DVT Following Hip or Knee Replacement Surgery:

• 10 mg orally once daily with or without food

Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in chronic CAD or PAD:

• 2.5 mg orally twice daily, with or without food, in combination with aspirin (75–100 mg) once daily

Administration:

• Take Xarelto exactly as prescribed by your doctor.
• Do not change your dose or stop taking Xarelto unless your doctor tells you to.
• Your doctor may change your dose if needed.
• If you take Xarelto for:
• atrial fibrillation that is not caused by a heart valve problem:
• Take Xarelto 1 time a day with your evening meal.
• If you miss a dose of Xarelto, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
• blood clots in the veins of your legs or lungs:
• Take Xarelto 1 or 2 times a day as prescribed by your doctor.
• For the 15 mg and 20 mg doses, Xarelto should be taken with food.
• For the 10 mg dose, Xarelto may be taken with or without food.
• Take your Xarelto doses at the same time each day.
• If you miss a dose:
• If you take the 15 mg dose of Xarelto 2 times a day (a total of 30 mg of Xarelto in 1 day): Take Xarelto as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.

• If you take Xarelto 1 time a day: Take Xarelto as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
• hip or knee replacement surgery:
• Take Xarelto 1 time a day with or without food.
• If you miss a dose of Xarelto, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
• reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral artery disease:
• Take Xarelto 2 times a day with or without food.
• If you miss a dose of Xarelto, take your next dose at your regularly scheduled time.
• If you have difficulty swallowing the Xarelto tablet whole, talk to your doctor about other ways to take Xarelto.
• Your doctor will decide how long you should take Xarelto.
• Xarelto may need to be stopped, if possible for one or more days before any surgery or medical or dental procedure. If you need to stop taking Xarelto for any reason, talk to the doctor who prescribed Xarelto to you to find out when you should stop taking it. Do not stop taking Xarelto without first talking to the doctor who prescribes it to you. 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 take too much Xarelto, go to the nearest hospital emergency room or call your doctor right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg

This medicine is available in fallowing brand namesː

• Xarelto

What side effects can this medication cause?

The most common side effects of this medicine include:

• bleeding

Xarelto may cause serious side effects, including:

• Increased risk of blood clots if you stop taking Xarelto
• Increased risk of bleeding

What special precautions should I follow?

• Xarelto can cause serious and fatal bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse the anti-factor Xa activity of rivaroxaban is available.
• Use Xarelto with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery. Promptly evaluate signs and symptoms of blood loss.
• Premature discontinuation of any oral anticoagulant, including Xarelto, increases the risk of thrombotic events. If anticoagulation with Xarelto is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
• Epidural or spinal hematomas have occurred in patients treated with Xarelto who are receiving neuraxial anesthesia or undergoing spinal puncture.
• Xarelto is not for use in people with artificial heart valves.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hemorrhage

Treatment of overdosage:

• Discontinue Xarelto and initiate appropriate therapy if bleeding complications associated with overdosage occur.
• The use of activated charcoal to reduce absorption in case of Xarelto overdose may be considered.
• Due to the high plasma protein binding, rivaroxaban is not dialyzable.
• Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
• An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

Can this medicine be used in pregnancy?

• The limited available data on Xarelto in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.
• Use Xarelto with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: rivaroxaban
• Inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

Who manufactures and distributes this medicine?

• Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ
• Licensed from: Bayer HealthCare AG Leverkusen, Germany

Janssen Pharmaceutical Companies

What should I know about storage and disposal of this medication?

• Store Xarelto at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Rivaroxaban
• FDA Rivaroxaban

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