Rivaroxaban Dosage

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Usual Adult Dose for Atrial Fibrillation

Recommended dose: 20 mg orally once a day

Use: Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation

Usual Adult Dose for Deep Vein Thrombosis

Initial dose: 15 mg orally twice a day for first 21 days of therapy
Maintenance dose: 20 mg orally once a day for the remaining duration of treatment.

Usual Adult Dose for Pulmonary Embolism

Initial dose: 15 mg orally twice a day for first 21 days of therapy
Maintenance dose: 20 mg orally once a day for the remaining duration of treatment.

Usual Adult Dose for Deep Vein Thrombosis - Recurrent Event

Recommended dose: 20 mg orally once a day

Use: Reduction in the risk of recurrence following initial 6 months treatment for DVT and/or PE.

Usual Adult Dose for Pulmonary Embolism - Recurrent Event

Recommended dose: 20 mg orally once a day

Use: Reduction in the risk of recurrence following initial 6 months treatment for DVT and/or PE.

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

Initial dose: 10 mg orally once a day starting 6 to 10 hours after surgery

Duration of therapy:
Hip replacement surgery: 35 days
Knee replacement surgery: 12 days

Comments: Treatment may be given as long as hemostasis has been established.

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

Initial dose: 10 mg orally once a day starting 6 to 10 hours after surgery

Duration of therapy:
Hip replacement surgery: 35 days
Knee replacement surgery: 12 days

Comments: Treatment may be given as long as hemostasis has been established.

Renal Dose Adjustments

Reduction in risk of stroke and systemic embolism in nonvalvular atrial fibrillation:
CrCl 15 to 50 mL/min: 15 mg orally once a day
CrCl 14 mL/min or less: Avoid use

Treatment of DVT, PE and reduction in risk of recurrence of DVT or PE:
CrCl 29 mL/min or less: Avoid use

Prophylaxis of DVT following hip or knee replacement surgery:
CrCl 30 to 50 mL/min: Use with caution and close monitoring; promptly evaluate any signs or symptoms of blood loss
CrCl 29 mL/min or less: Avoid use

Discontinue if patients develop acute renal failure while on rivaroxaban.

Liver Dose Adjustments

Moderate to severe liver dysfunction (Child-Pugh B and C) or hepatic disease associated with coagulopathy: Avoid use

Dose Adjustments

SWITCHING TO AND FROM RIVAROXABAN:
-Switching from warfarin to rivaroxaban: Discontinue warfarin and start rivaroxaban as soon as the INR is below 3.0.
-Switching from rivaroxaban to warfarin: Data not available. The manufacturer suggests discontinuing rivaroxaban and beginning both a parenteral anticoagulant and warfarin at the time the next dose of rivaroxaban would have been taken.
-Switching from rivaroxaban to anticoagulants with rapid onset: Discontinue rivaroxaban and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next rivaroxaban dose would have been taken.
-Switching from anticoagulants other than warfarin to rivaroxaban: Start rivaroxaban 0 to 2 hours prior to the next scheduled evening administration of the other anticoagulant and omit the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start rivaroxaban at the same time.

DISCONTINUATION FOR SURGERY AND OTHER INTERVENTIONS:
-Rivaroxaban should be stopped at least 24 hours prior to the procedure.
-Rivaroxaban should be restarted after the procedure as soon as hemostasis has been established.
-Use of a parenteral anticoagulant should be considered if oral medication cannot be taken during or after the surgical intervention.
-If a decision needs to be made whether to delay a procedure until 24 hours after the last dose of rivaroxaban, the increased risk of bleeding should be weighed against the urgency of the intervention.

Precautions

BOXED WARNING(S):
-PREMATURE TREATMENT DISCONTINUATION: There is an increased risk of thrombotic events following premature discontinuation of rivaroxaban therapy. Consider administering another anticoagulant if rivaroxaban is discontinued for reasons other than pathological bleeding or completion of a course of therapy.
-SPINAL/EPIDURAL HEMATOMA: Use of indwelling epidural catheters, drugs that affect hemostasis (NSAIDs, platelet inhibitors, other anticoagulants), history of traumatic or repeated epidural punctures, spinal punctures, spinal deformity, or spinal surgery can increase risk of developing epidural or spinal hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas can result in long-term or permanent paralysis. Monitor for signs and symptoms of neurological impairment. Consider the benefits and risks prior to neuraxial intervention in anticoagulated patients or patients to be anticoagulated for thromboprophylaxis. The optimal timing between administration of rivaroxaban and neuraxial procedures is unknown. Urgent treatment is required if neurological compromise is noted.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available; rivaroxaban is not expected to be dialyzable.

Other Comments

Administration advice:
-The 10 mg tablets can be taken with or without food. The 15 and 20 mg tablets should be taken with food at same time every day.
-When used for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, it is recommended to take the dose with the evening meal.
-Patients unable to swallow tablets: Crush the 15 mg or 20 mg tablets and mix with applesauce immediately prior to use. Follow the administration of the crushed tablets with food.
-Patients with nasogastric (NG) tube or gastric feeding tube: Confirm the gastric placement of the tube. Crush the 15 mg or 20 mg tablets and suspend in 50 mL of water and administer through the NG or gastric feeding tubes. Follow the administration by an enteral feeding. Avoid administration distal to the stomach can result in reduced absorption and drug exposure.

Missed Dose:
-Patients on the 10 mg, 15 mg or 20 mg once a day regimen: Take the missed dose immediately and continue on the following day with the once a day dose as per the regular schedule. The dose should not be doubled within the same day.
-Patients on the 15 mg twice a day regimen: Take immediately to ensure a 30 mg daily dose. Two 15 mg tablets can be taken at the same time. The patient should continue with the regular 15 mg twice a day regimen on the following day.

Storage requirements:
-The crushed tablets are stable in water and applesauce for up to 4 hours.

General:
-In vitro studies showed no adsorption of the rivaroxaban in water suspension to PVC or silicone NG tubing.
-A specific antidote for rivaroxaban is not available.
-INR is not a valid measure of the anticoagulant activity of rivaroxaban.
-Rivaroxaban can contribute to an elevated INR; INR measurements made during coadministration with warfarin may not be useful for determining the appropriate dose of the vitamin K antagonist.

Monitoring:
-General: If monitoring is necessary for bleeding or emergency surgery, prothrombin time (PT) or the anti-Factor Xa are best suited for measuring the anticoagulation effect of rivaroxaban.
-Hematologic: Signs or symptoms of blood loss
-Neurologic: Signs or symptoms suggestive of epidural or spinal hematoma in patients undergoing neuraxial anesthesia or spinal puncture.
-Renal: Renal function
-Therapeutic drug monitoring: Not recommended; reliable monitoring of the anticoagulant effect of rivaroxaban is not possible with standard laboratory testing.

Patient advice:
-You may bruise or bleed more easily while on rivaroxaban therapy.
-Report any unusual bleeding or bruising to your physician.
-If you've had neuraxial anesthesia or spinal puncture, watch for signs and symptoms of epidural hematoma, such as back pain, tingling, numbness, muscle weakness, and stool or urine incontinence.
-This medicine may cause dizziness and fainting. Do not drive or operate machinery if you experience these effects.

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