rivaroxaban(redirected from Bay 59-7939)
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Pregnancy Category: C
Prevention of deep vein thrombosis that may lead to pulmonary embolism following knee or hip replacement surgery.Reduction in risk of stroke/systemic embolism in patients with nonvalvular atrial fibrillationTreatment of and reduction in risk of recurrence of deep vein thrombosis or pulmonary embolism
Acts as selective factor X inhibitor that blocks the active site of factor Xa, inactivating the cascade of coagulation.
Prevention of blood clots and subsequent pulmonary emboli following knee/hip replacement surgery.
Absorption: Well absorbed (80%) following oral administration; absorption occurs in the stomach and decreases as it enters the small intestine.
Metabolism and Excretion: 51% metabolized by the liver; 36% excreted unchanged in urine. Metabolites do not have anticoagulant activity.
Half-life: 5–9 hr.
Time/action profile (anticoagulant effect)
|PO||unknown||2–4 hr†||24 hr|
Contraindicated in: Hypersensitivity;Active major bleeding;Severe renal impairment [CCr <30 mL/min (deep vein thrombosis/pulmonary embolism treatment or prevention); CCr <15 mL/min (atrial fibrillation)];Prosthetic heart valvesModerate to severe hepatic impairment (Child-Pugh B or C) or any liver pathology resulting in altered coagulation; Lactation: Avoid breast feeding;Concurrent use of drugs that are combined P-gp inducers/CYP3A4 inducers or combined P-gp inhibitors/CYP3A4 inhibitors.
Use Cautiously in: Neuroaxial spinal anesthesia or spinal puncture, especially if concurrent with an indwelling epidural catheter, drugs affecting hemostasis, history of traumatic/repeated spinal puncture or spinal deformity (↑ risk of spinal hematoma);Use of feeding tube (proper placement of tube must be documented to ensure absorption); Obstetric: Use only if potential benefit outweighs potential risk.
Adverse Reactions/Side Effects
Central nervous system
- bleeding (life-threatening)
- wound secretion
- extremity pain
- muscle spasm
Drug-Drug interactionRivaroxaban acts as a substrate of these subsets of the CYP450 enzyme system: CYP3A4/5, CYP2J2, and ATP-binding cassette G2 (ABCG2). Drugs that inhibit or induce these systems may alter effectiveness.Concurrent use of drugs that are combined P-gp inhibitors/strong CYP3A4 inhibitors, including ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan may ↑ levels; avoid concomitant useConcurrent use of drugs that are combined P-gp inducers/strong CYP3A4 inducers, including carbamazepine, phenytoin, or rifampin may ↓ levels; avoid concomitant use.Concurrent use with aspirin or NSAIDs may ↑ the risk of bleeding.Concurrent use of clopidogrel or other anticoagulants may ↑ risk of bleeding and should be avoided.St. John's wort ↓ levels of rivaroxaban and should be avoided.
Prevention of Deep Vein Thrombosis Following Knee or Hip Replacement Surgery
Oral (Adults) 10 mg once daily, initiated 6–10 hr post-operatively (when hemostasis is achieved) continued for 35 days after hip replacement or 12 days after knee replacement.
Reduction in Risk of Stroke/Systemic Embolism in Nonvalvular Atrial Fibrillation
Oral (Adults) 20 mg once daily with evening meal.
Renal ImpairmentOral (Adults) CCr 15–50 mL/min—15 mg once daily with evening meal
Treatment of and Reduction in Risk of Recurrence of Deep Vein Thrombosis or Pulmonary Embolism
Oral (Adults) 15 mg twice daily for 21 days, then 20 mg once daily for remainder of treatment period.
Tablets: 10 mg, 15 mg, 20 mg
- Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stools; hematuria; fall in hematocrit or BP; guaiac-positive stools); bleeding from surgical site. Notify health care professional if these occur.
- Monitor patients with epidural catheters frequently for signs and symptoms of neurologic impairment. Epidural catheter should not be removed earlier than 18 hr after last administration of rivaroxaban; next dose should be at least 6 hr after catheter removal.
- Lab Test Considerations: May cause ↑ serum AST, ALT, total bilirubin, and GGT levels.
Potential Nursing DiagnosesIneffective tissue perfusion (Indications)
Risk for injury (Side Effects)
- When switching from warfarin to rivaroxaban, discontinue warfarin and start rivaroxaban as soon as INR <3.0 to avoid periods of inadequate anticoagulation. When switching from anticoagulants other than warfarin to rivaroxaban, start rivaroxaban 0 to 2 hr prior to next scheduled evening dose and omit dose of other anticoagulant. For continuous heparin, discontinue heparin and administer rivaroxaban at same time. When switching from rivaroxaban to warfarin or other anticoagulants, no data is available. May discontinue rivaroxaban and begin both parenteral anticoagulant and warfarin at time of next rivaroxaban dose.
- Discontinue at least 24 hr prior to surgery and other interventions. Restart as soon as hemostasis has been restablished.
- If rivaroxaban must be discontinued for other than bleeding, consider replacing with another anticoagulant; discontinuation increases risk of thrombotic events.
- Oral: Administer first dose 6–10 hr after surgery, once hemostasis has been established. 10-mg tablet may be administered without regard to food; 15-mg and 20-mg tablet should be taken with food.
- If unable to swallow tablet, 15-mg and 20-mg tablets may be crushed, mixed with applesauce, and administered immediately after mixing. Follow dose immediately with food. Tablets are stable in applesauce for up to 4 hr.
- If administering crushed tablet via GI feeding tube, check placement of tube. Rivaroxaban is absorbed from the GI tract, not the small intestine. Suspend crushed tablet in 50 mL water and administer. Follow administration of 15-mg or 20-mg tablet immediately with food.
- Instruct patient to take medication as directed. Take missed doses as soon as remembered that day. If taking 15 mg twice daily, may take two 15-mg tablets to achieve 30 mg daily dose, then return to regular schedule. If taking 10 mg, 15 mg, or 20 mg once daily, take missed dose immediately. Inform health care professional of missed doses at time of checkup or lab tests. Inform patients that anticoagulant effect may persist for 2–5 days following discontinuation. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes. Caution patients not to discontinue medication early without consulting health care professional.
- Advise patient to report any symptoms of unusual bleeding or bruising (bleeding gums; nosebleed; black, tarry stools; hematuria; excessive menstrual flow) and symptoms of spinal or epidural hematoma (tingling; numbness, especially in lower extremities; muscular weakness) to health care professional immediately.
- Instruct patient not to drink alcohol or take other Rx, OTC, or herbal products, especially those containing aspirin or NSAIDs, or to start or stop any new medications during rivaroxaban therapy without advice of health care professional.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Prevention of blood clots and subsequent pulmonary emboli following knee/hip replacement surgery. Duration of treatment is 35 days for patients with hip replacement and 12 days for patients with knee replacement surgery.