rivaroxaban: clinical use

Prescribing considerations

• Confirm that the indication, age or weight criteria and formulation match the relevant product licence.
• Assess bleeding and thrombotic risks, renal and hepatic function, interacting medicines, adherence and planned invasive procedures.
• Use Cockcroft–Gault creatinine clearance for renal assessment; estimated glomerular filtration rate may overestimate renal function for direct oral anticoagulants.
• Use particular caution with advanced age, frailty, renal impairment, active cancer, gastrointestinal or genitourinary lesions, uncontrolled hypertension and other medicines affecting haemostasis.
• Rivaroxaban is not recommended for triple-positive antiphospholipid syndrome. Evidence is insufficient for most prosthetic heart valves.

Contraindications and cautions

• Hypersensitivity to rivaroxaban or a formulation excipient.
• Active clinically significant bleeding.
• A lesion or condition carrying a significant risk of major bleeding.
• Concomitant anticoagulation except in specified switching or catheter-related circumstances.
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including Child–Pugh B or C cirrhosis.
• Pregnancy and breastfeeding under the selected product licences.

Monitoring

• Before treatment: full blood count, liver function, urea and electrolytes, serum creatinine with calculated creatinine clearance, body weight and baseline clotting screen.
• Routine INR or dose titration against coagulation tests is not required.
• Review after initiation or a relevant change, then periodically when stable; reassess more often with frailty, advanced age, renal impairment, interacting medicines or intercurrent illness.
• Assess adherence, bleeding or anaemia, thromboembolic symptoms, adverse effects and new prescribed, non-prescription or herbal medicines.
• An unexplained fall in haemoglobin, haematocrit or blood pressure should prompt assessment for occult bleeding.

Clinical pharmacology

Rivaroxaban is an orally active, highly selective direct factor Xa inhibitor. It reduces thrombin generation and thrombus formation; INR is not calibrated to quantify its anticoagulant effect.

Formulation and product differences

• The selected film-coated tablet requires food, must not be divided to provide a partial tablet, and may be crushed when supported by the product instructions.
• The selected hard capsule may be taken without regard to food and opened for immediate mixing with water or apple purée.
• The ready-to-use suspension must be shaken before use and measured with its oral syringe; food requirements depend on the prescribed amount.
• Crushed tablets, opened capsules and suspension may be suitable for gastric-tube delivery, but administration beyond the stomach should be avoided because exposure may be reduced.
• Excipients differ between products; check the individual product information where intolerance, allergy or metabolic effects are relevant.

Capsule

Route: Oral

Strengths: 10 mg, 15 mg, 20 mg

Oral suspension

Route: Oral

Strengths: 1 mg/mL, 5 mg/mL