Haemorrhagic risk: Caution in conditions with increased risk of haemorrhage (congenital or acquired bleeding disorders; uncontrolled severe arterial hypertension; other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications; vascular retinopathy; bronchiectasis or history of pulmonary bleeding). Xelostad 10 administration should be discontinued if severe haemorrhage occurs.
- Caution in patients with creatinine clearance 15 – 29 ml/min. Use is not recommended in patients with creatinine clearance < 15 ml/min.
- In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations Xelostad 10 is to be used with caution.
Interaction with other medicinal products:
- The use of Xelostad 10 is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors.
- Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as nonsteroidal anti-inflammatory medicinal products NSAIDs), acetylsalicylic acid (ASA) and platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).
Safety and efficacy of Xelostad 10 have not been studied in patients with prosthetic heart valves. Treatment with Xelostad 10 is not recommended for these patients.
Rivaroxaban has not been studied in interventional clinical trials in patients undergoing hip fracture surgery to evaluate efficacy and safety.
Spinal/epidural anaesthesia or puncture:
- Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis. Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g. numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary.
- At least 18 hours should elapse after the last administration of rivaroxaban before removal of an epidural catheter. Following removal of the catheter, at least 6 hours should elapse before the next rivaroxaban dose is administered. If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Dosing recommendations before and after invasive procedures and surgical intervention other than elective hip or knee replacement surgery:
- If an invasive procedure or surgical intervention is required, Xelostad 10 should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
- If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention.
- Xelostad 10 should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician.
Elderly population: Increasing age may increase haemorrhagic risk.
Dermatological reactions: Rivaroxaban should be discontinued at the first appearance of a severe skin rash (e.g. spreading, intense and/or blistering), or any other sign of hypersensitivity in conjunction with mucosal lesions.
Xelostad 10 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.Patients should be aware of how they react to drug before driving or operating machinery.
Xelostad 10 is contraindicated during pregnancy and lactation.
Patients should be aware of how they react to drug before driving or operating machinery.