rivaroxaban


Also found in: Dictionary, Wikipedia.
Related to rivaroxaban: Apixaban, Pradaxa, Dabigatran

rivaroxaban

(ri-va-rox-a-ban) ,

Xarelto

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: antithrombotics
Pregnancy Category: C

Indications

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

Action

Acts as selective factor X inhibitor that blocks the active site of factor Xa, inactivating the cascade of coagulation.

Therapeutic effects

Prevention of blood clots and subsequent pulmonary emboli following knee/hip replacement surgery.

Pharmacokinetics

Absorption: Well absorbed (80%) following oral administration; absorption occurs in the stomach and decreases as it enters the small intestine.
Distribution: Unknown.
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)

ROUTEONSETPEAKDURATION
POunknown2–4 hr†24 hr
† blood levels

Contraindications/Precautions

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

  • syncope

Dermatologic

  • blister
  • prutitus

Hematologic

  • bleeding (life-threatening)

Local

  • wound secretion

Musculoskeletal

  • extremity pain
  • muscle spasm

Interactions

Drug-Drug interaction

Rivaroxaban 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.

Route/Dosage

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 Impairment

Oral (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.

Availability

Tablets: 10 mg, 15 mg, 20 mg

Nursing implications

Nursing assessment

  • 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 Diagnoses

Ineffective tissue perfusion (Indications)
Risk for injury (Side Effects)

Implementation

  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • 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.
Mentioned in ?
References in periodicals archive ?
In the recently initiated CALLISTO Clinical Research Programme Bayer is exploring the potential benefits of rivaroxaban in patients with cancer.
Janssen) and its development partner, Bayer HealthCare, today announced the first results from CALLISTO, a comprehensive research program that includes nine studies of their non-vitamin K antagonist oral anticoagulant (NOAC) rivaroxaban in people with active cancer.
According to some experts, rivaroxaban and dabigatran are the most promising antithrombotic agents which will add a new milestone to the development of cardiovascular drugs.
Rivaroxaban was discontinued, and the patient was switched to a new anticoagulant, acenocoumarol.
A meta-analysis of efficacy and safety of NOACs across three randomized, controlled trials and more than 44,000 individuals--Apixaban for Reduction of Stroke and Other Thromboembolic Events in Atrial Fibrillation, Randomized Evaluation of Long-Term Anticoagulation Therapy, and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation--showed better efficacy in preventing stroke and systemic embolism than warfarin (Miller, Grandi, Shimony, Filion, & Eisenberg, 2012).
I have heard that despite the writing up on Blue Sphere [a computer record] of the prescription for Rivaroxaban and mechanical prophylaxis, the instruction was not followed.
Rivaroxaban, apixaban and edoxaban are very specific antagonists of activated factor Xa, which directly converts prothrombin to thrombin, thus leading to clot formation.
Similar to rivaroxaban, much of the drug is metabolized in the liver with a cytochrome P450-dependent way and apixaban is also a substrate for transport P-gp (8).
Other studies confirm that APTT is insensitive to high concentrations of dabigatran and rivaroxaban (>150-200 [micro]g/L) owing to its curvilinear response (5, 8).
The CHMP recommendation to approve rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important clinical findings from the pivotal, global Phase III EINSTEIN-PE study.
The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today.
This edition includes new drugs, including Azilsartan Medoxomil, Boceprevir, Clobazam, Ezogabine, Fidaxomicin, Linagliptin, Rilpivirine, Rivaroxaban, Telaprevir, Roflumilast, Ticagrelor, and Vilazodone; updated bisphosphonate, antipsychotic, carbapenem, and proton pump inhibitor group monographs; new combinations such as Emtricitabine/Rilpivirine/Tenofovir; and a revised ophthalmic/otic chapter with additions like glaucoma combinations, mast cell stabilizers, ophthalmic antihistamines, and otic corticosteroids.