Rivaroxaban

XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease ( …

• Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food Treatment of DVT and/or PE : 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 Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily
• Pediatric Patients: See dosing recommendations in the Full Prescribing Information Recommended Dosage
• In Adults Table 1: Recommended Dosage
• In Adults Indication Renal Considerations Calculate CrCl based on actual weight [see Warnings and Precautions and Use in Specific Populations ]
• Dosage Food/Timing [See Clinical Pharmacology ]
• Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation CrCl >50 mL/min 20 mg once daily
• Take with evening meal CrCl ≤50 mL/min Patients with CrCl

2.5 mg tablets: Round, light yellow, and film-coated with a triangle pointing down above a "2.5" marked on one side and "Xa" on the other side 10 mg tablets: Round, light red, biconvex and film-coated with a triangle pointing down above a "10" marked on one side and "Xa" on the other side 15 mg tablets: Round, red, biconvex, and film-coated with a triangle pointing down above a "15" marked on one …

• The safety and effectiveness of XARELTO have been established
• In pediatric patients from birth to less than 18 years
• For the treatment of VTE and the reduction in risk of recurrent VTE
• Use of XARELTO is supported in these age groups by evidence from adequate and well-controlled studies of XARELTO
• In adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, open-label, active-controlled randomized study in 500
• Pediatric patients from birth to less than 18 years of age. …

Of the total number of adult patients in clinical trials for the approved indications of XARELTO (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. In clinical trials the efficacy of XARELTO in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. …

• For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide)
• For the suspension, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)
• Instructions for Patient Use Advise patients to take XARELTO only as directed
• Remind patients to not discontinue XARELTO without first talking to their healthcare professional
• Adults Advise patients with atrial fibrillation to take XARELTO once daily with the evening meal. …

XARELTO is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to XARELTO ( 4 )

Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) Anticoagulants: Avoid concomitant use ( 7.4 ) 7.1 General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters, the latter also known as breast cancer resistance protein (BCRP). Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events. …

Risk of bleeding: XARELTO can cause serious and fatal bleeding ( 5.2 ) Pregnancy-related hemorrhage: Use XARELTO with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery ( 5.7 , 8.1 ) Prosthetic heart valves: XARELTO use not recommended ( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: XARELTO use not recommended ( 5.10 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. …

The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions (5.1) ] Bleeding Risk [see Warnings and Precautions (5.2 , 5.4 , 5.5 , 5.6 , 5.7) ] Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions (5.3) ] The most common adverse reaction (>5%) in adult patients was bleeding ( 6.1 ) The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. …

8.1 Pregnancy Risk Summary 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. The anticoagulant effect of XARELTO cannot be reliably monitored with standard laboratory testing. …

Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. 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 [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] . …

Storage of tablets, granules and reconstituted suspension: Store at room temperature between 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.