Rivaroxaban
Dosing in kidney impairment
Recommended Dosage in Adults [See table below.] CrCl <15 mL/min Avoid Use Prophylaxis of DVT Following: - Hip Replacement Surgery CrCl ≥15 mL/min 10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use - Knee Replacement Surgery [See Dosage and Administration ] .
CrCl ≥15 mL/min 10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding CrCl ≥15 mL/min 10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days Take with or without food CrCl <15 mL/min Avoid Use Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily.
When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food
| Indication | Renal ConsiderationsCalculate CrCl based on actual weight [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]. | Dosage | Food/Timing[See Clinical Pharmacology (12.3)]. |
|---|---|---|---|
| Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation | CrCl >50 mL/min | 20 mg once daily | Take with evening meal |
| CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]. | 15 mg once daily | Take with evening meal | |
| Treatment of DVT and/or PE | CrCl ≥15 mL/min | 15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily | Take with food, at the same time each day |
| CrCl <15 mL/min | Avoid Use | ||
| Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE | CrCl ≥15 mL/min | 10 mg once daily, after at least 6 months of standard anticoagulant treatment | Take with or without food |
| CrCl <15 mL/min | Avoid Use | ||
| Prophylaxis of DVT Following: | |||
| CrCl ≥15 mL/min | 10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established | Take with or without food | |
| CrCl <15 mL/min | Avoid Use | ||
| CrCl ≥15 mL/min | 10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established | Take with or without food | |
| CrCl <15 mL/min | Avoid Use | ||
| Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding | CrCl ≥15 mL/min | 10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days | Take with or without food |
| CrCl <15 mL/min | Avoid Use | ||
| Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD | No dose adjustment needed based on CrCl | 2.5 mg twice daily, plus aspirin (75–100 mg) once daily | Take with or without food |
| Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD | No dose adjustment needed based on CrCl | 2.5 mg twice daily, plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. | Take with or without food |
Dosing in liver impairment
Hepatic Impairment In a pharmacokinetic study, compared to healthy adult subjects with normal liver function, AUC increases of 127% were observed in adult subjects with moderate hepatic impairment (Child-Pugh B). The safety or PK of XARELTO in patients with severe hepatic impairment (Child-Pugh C) has not been evaluated [see Clinical Pharmacology ] .
Avoid the 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. No clinical data are available in pediatric patients with hepatic impairment.
Preparation and administration
Administration Options For adult patients who are unable to swallow whole tablets, XARELTO tablets (all strengths) may be crushed and mixed with applesauce immediately prior to use and administered orally. After the administration of a crushed XARELTO 15 mg or 20 mg tablet, the dose should be immediately followed by food.
Administration with food is not required for the 2.5 mg or 10 mg tablets [see Clinical Pharmacology ] . Administration of XARELTO tablets via nasogastric (NG) tube or gastric feeding tube: After confirming gastric placement of the tube, XARELTO tablets (all strengths) may be crushed and suspended in 50 mL of water and administered via an NG tube or gastric feeding tube.
Since rivaroxaban absorption is dependent on the site of drug release, avoid administration of XARELTO distal to the stomach which can result in reduced absorption and thereby, reduced drug exposure. After the administration of a crushed XARELTO 15 mg or 20 mg tablet, the dose should then be immediately followed by enteral feeding.
Enteral feeding is not required following administration of the 2.5 mg or 10 mg tablets [see Clinical Pharmacology ] . Crushed XARELTO tablets (all strengths) are stable in water and in applesauce for up to 4 hours. An in vitro compatibility study indicated that there is no adsorption of rivaroxaban from a water suspension of a crushed XARELTO tablet to PVC or silicone nasogastric (NG) tubing.
Administration of XARELTO suspension via NG tube or gastric feeding tube : XARELTO oral suspension may be given through NG or gastric feeding tube. After the administration, flush the feeding tube with water. For the treatment or reduction in risk of recurrent VTE in pediatric patients, the dose should then be immediately followed by enteral feeding to increase absorption.
For the thromboprophylaxis in pediatric patients with congenital heart disease who have undergone the Fontan procedure, the dose does not require to be followed by enteral feeding. An in vitro compatibility study indicated that XARELTO suspension can be used with PVC, polyurethane or silicone NG tubing.
Preparation Instructions for Pharmacy of XARELTO for Oral Suspension Do not add flavor as product is already flavored (sweet and creamy). Reconstitute before dispensing: Tap the bottle until all granules flow freely. Add 150 mL of purified water for reconstitution. Shake for 60 seconds. Check that all granules are wetted and the suspension is uniform.
Push the adaptor into bottleneck and recap bottle. The suspension must be used within 60 days. Write the "Discard after" date on the bottle and carton. Dispensing Instructions: Dispense in the original bottle. Dispense the bottle upright with the syringes provided in the original carton. Store reconstituted suspension 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).
Do not freeze. It is recommended the pharmacist counsel the caregiver on proper use. Alert the patient or caregiver to read the Medication Guide and Instructions for Use.