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XARELTO ® (rivaroxaban)

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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WARNINGS  top of page

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 [see package insert for Dosage and Administration (2.1), Warnings and Precautions (5.1), and Clinical Studies (14.1)].

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

[see package insert Warnings and Precautions (5.2, 5.3) and Adverse Reactions (6.2)].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary see package insert Warnings and Precautions (5.3)].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

(DESCRIPTION) top of page

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XARELTO® (rivaroxaban) safely and effectively. See full prescribing information for XARELTO.

XARELTO (rivaroxaban) tablets, for oral use
Initial U.S. Approval: 2011

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action
XARELTO is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
XARELTO is a factor Xa inhibitor indicated:
(1) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

(2) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery

USE IN SPECIFIC POPULATIONS
Nursing mothers: discontinue drug or discontinue nursing

Renal impairment:
Prophylaxis of DVT: Avoid use in patients with severe impairment (CrCl <30 mL/min).
Use with caution in moderate impairment (CrCl 30 to <50 mL/min)

CONTRAINDICATIONS top of page

CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to XARELTO

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS
Risk of bleeding: XARELTO can cause serious and fatal bleeding. Promptly evaluate signs and symptoms of blood loss.

Pregnancy related hemorrhage: 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.

DRUG INTERACTIONS
Combined P-gp and strong CYP3A4 inhibitors and inducers: Avoid concomitant use.
Prophylaxis of DVT: Anticoagulants: Avoid concomitant use

ADVERSE REACTIONS top of page

ADVERSE REACTIONS

The most common adverse reaction (>5%) was bleeding.

To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION

2.1 Nonvalvular Atrial Fibrillation

For patients with creatinine clearance (CrCl) >50 mL/min, the recommended dose of XARELTO is 20 mg taken orally once daily with the evening meal. For patients with CrCl 15 to 50 mL/min, the recommended dose is 15 mg once daily with the evening meal [see package insert for Use in Specific Populations (8.7)].

Switching from or to Warfarin - When switching patients from warfarin to XARELTO, discontinue warfarin and start XARELTO as soon as the International Normalized Ratio (INR) is below 3.0 to avoid periods of inadequate anticoagulation.

No clinical trial data are available to guide converting patients from XARELTO to warfarin. XARELTO affects INR, so INR measurements made during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue XARELTO and begin both a parenteral anticoagulant and warfarin at the time the next dose of XARELTO would have been taken.

Switching from or to Anticoagulants other than Warfarin - For patients currently receiving an anticoagulant other than warfarin, start XARELTO 0 to 2 hours prior to the next scheduled evening administration of the drug (e.g., low molecular weight heparin or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start XARELTO at the same time.

For patients currently taking XARELTO and transitioning to an anticoagulant with rapid onset, discontinue XARELTO and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next XARELTO dose would have been taken.

2.2 Prophylaxis of Deep Vein Thrombosis
The recommended dose of XARELTO is 10 mg taken orally once daily with or without food. The initial dose should be taken at least 6 to 10 hours after surgery once hemostasis has been established.

-For patients undergoing hip replacement surgery, treatment duration of 35 days is recommended.
-For patients undergoing knee replacement surgery, treatment duration of 12 days is recommended.

2.3 General Dosing Instructions
Hepatic Impairment:
No clinical data are available for patients with severe hepatic impairment. Avoid use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy [see Use in Specific Populations (8.8)].

Renal Impairment:
Nonvalvular Atrial Fibrillation:
Avoid the use of XARELTO in patients with CrCl <15 mL/min. Periodically assess renal function as clinically indicated (i.e., more frequently in situations in which renal function may decline) and adjust therapy accordingly. Discontinue XARELTO in patients who develop acute renal failure while on XARELTO [see Use in Specific Populations (8.7)].

Prophylaxis of Deep Vein Thrombosis:
Avoid the use of XARELTO in patients with severe renal impairment (CrCl <30 mL/min) due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with moderate renal impairment (CrCl 30 to 50 mL/min). Patients who develop acute renal failure while on XARELTO should discontinue the treatment [see Use in Specific Populations (8.7)].

Surgery and Intervention:
If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, XARELTO should be stopped at least 24 hours before the procedure. In deciding whether a procedure should be delayed until 24 hours after the last dose of XARELTO, the increased risk of bleeding should be weighed against the urgency of intervention. XARELTO should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established. If oral medication cannot be taken after surgical intervention, consider administering a parenteral anticoagulant.

Missed Dose:
If a dose of XARELTO is not taken at the scheduled time, administer the dose as soon as possible on the same day.

Use with P-gp and Strong CYP3A4 Inhibitors or Inducers:
Avoid concomitant use of XARELTO with combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan) [see Drug Interactions (7.1)].

Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort)

HOW SUPPLIED top of page

HOW SUPPLIED/STORAGE AND HANDLING

XARELTO (rivaroxaban) Tablets are available in the strengths and packages listed below:

10 mg tablets are round, light red, biconvex film-coated tablets marked with a triangle pointing down above a "10" on one side, and an "Xa" on the other side. The tablets are supplied in the packages listed:
NDC 50458-580-30 Bottle containing 30 tablets
NDC 50458-580-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)

15 mg tablets are round, red, biconvex film-coated tablets with a triangle pointing down above a "15" marked on one side and "Xa" on the other side. The tablets are supplied in the packages listed:
NDC 50458-578-30 Bottle containing 30 tablets
NDC 50458-578-90 Bottle containing 90 tablets
NDC 50458-578-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)

20 mg tablets are triangle-shaped, dark red film-coated tablets with a triangle pointing down above a "20" marked on one side and "Xa" on the other side. The tablets are supplied in the packages listed:
NDC 50458-579-30 Bottle containing 30 tablets
NDC 50458-579-90 Bottle containing 90 tablets
NDC 50458-579-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)

Store at 25° C (77° F) or room temperature; excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].

Keep out of the reach of children.

REFERENCE

Package Insert data: 
Issued: November 2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Finished Product Manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

Licensed from:
Bayer HealthCare AG
51368 Leverkusen, Germany

© Janssen Pharmaceuticals, Inc. 2011

Trademarks are property of their respective owners.

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 50458-580-30
30 Tablets

Xarelto®
(rivaroxaban)
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