Drug Guide
Rivaroxaban
Classification
Therapeutic: Anticoagulant
Pharmacological: Factor Xa inhibitor
FDA Approved Indications
- Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT)
- Treatment of pulmonary embolism (PE)
- Prevention of DVT and PE in patients undergoing knee or hip replacement surgery
Mechanism of Action
Rivaroxaban selectively inhibits factor Xa, thereby impeding thrombin formation and thrombus development.
Dosage and Administration
Adult: Dosing varies based on indication; typically, 20 mg once daily for atrial fibrillation, with dose adjustments based on renal function. For DVT/PE treatment, initial doses may be higher with subsequent reduction. Follow specific prescribing information.
Pediatric: Not approved for pediatric use.
Geriatric: Adjust dose based on renal function and bleeding risk; increased caution advised.
Renal Impairment: Adjust dose or avoid in severe impairment; dose adjustments based on creatinine clearance.
Hepatic Impairment: Contraindicated in severe hepatic impairment; caution in mild to moderate impairment.
Pharmacokinetics
Absorption: Rapid, with peak plasma concentrations in 2-4 hours.
Distribution: Approximately 95% bound to plasma proteins.
Metabolism: Metabolized mainly by CYP3A4/5 and CYP2J2.
Excretion: Excreted via renal and fecal routes.
Half Life: 7-13 hours, depending on age and renal function.
Contraindications
- Active bleeding
- Severe hepatic impairment
- Known hypersensitivity
Precautions
- Use with caution in patients with bleeding disorders, recent surgery, or compromised renal function. Monitor renal function periodically.
Adverse Reactions - Common
- Bleeding (Common)
- Anemia (Uncommon)
Adverse Reactions - Serious
- Major bleeding including intracranial hemorrhage (Rare)
- Thrombocytopenia (Rare)
Drug-Drug Interactions
- Other anticoagulants, antiplatelet drugs, NSAIDs, serotonergic drugs
Drug-Food Interactions
- Limited data, but avoid excessive alcohol intake.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor bleeding signs, renal function, and complete blood counts.
Diagnoses:
- Risk for bleeding
- Risk for thrombosis if therapy is interrupted
Implementation: Administer as prescribed, monitor for bleeding, educate patient on bleeding precautions.
Evaluation: Assess for signs of bleeding, efficacy in preventing thromboembolic events.
Patient/Family Teaching
- Do not discontinue medication without medical advice.
- Report any signs of bleeding or bruising immediately.
- Use of other drugs or supplements should be discussed with healthcare provider.
- Avoid activities that may cause injury.
Special Considerations
Black Box Warnings:
- Risk of bleeding; discontinue at first sign of bleeding.
- Sudden discontinuation increases risk of thrombotic events.
Genetic Factors: N/A
Lab Test Interference: May affect PT and aPTT results but not suitable for monitoring anticoagulation effect.
Overdose Management
Signs/Symptoms: Excessive bleeding, anemia, hypotension, shock.
Treatment: Discontinue drug, provide supportive care, and consider administration of activated charcoal if ingestion is recent. Specific reversal agents like andexanet alfa may be used in severe cases.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable through the expiration date when stored properly.