Rivarox-20 Special Precautions

Patients with prosthetic valves: Safety and efficacy of rivaroxaban, have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that rivaroxaban 20 mg provides adequate anticoagulation in this patient population.
Patients with high risk triple positive antiphospholipid syndrome: Rivaroxaban is not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome and are persistently triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies) as treatment with rivaroxaban is associated with an increased rate of recurrent thrombotic events compared with vitamin K antagonists (VKA).
Concomitant medication: Rivaroxaban is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (e.g. ketoconazole) or HIV protease inhibitors (e.g. ritonavir). These drugs are strong inhibitors of both CYP 3A4 and P-gp. Therefore, these drugs may increase rivaroxaban plasma concentrations to a clinically relevant degree (2.6-fold on average) which may lead to an increased bleeding risk. The Azole antimycotic fluconazole, a moderate CYP 3A4 inhibitor has however less effect on rivaroxaban exposure and can be co-administered.
DVT and PE Treatment in renal impairment: Rivaroxaban is to be used with caution in patients with moderate renal impairment receiving co-medications leading to increased rivaroxaban plasma concentrations.
SPAF, DVT and PE treatment in renal impairment: In patients with severe renal impairment rivaroxaban plasma levels may be significantly elevated (1.6-fold on average) which may lead to an increased bleeding risk.
Due to limited clinical data rivaroxaban should be used with caution in patients with CrC <30-15 mL/min.
No clinical data are available for patients with severe renal impairment. Therefore use of rivaroxaban is not recommended in these patients.
Patients with severe renal impairment or increased bleeding risk and patients receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors are to be carefully monitored for signs of bleeding complications after initiation of treatment.
Bleeding risk: Rivaroxaban like other antithrombotic should be used with caution in patients with an increased bleeding risk such as: Congenital or acquired bleeding disorders; Uncontrolled severe arterial hypertension; Active ulcerative gastrointestinal disease; Recent gastrointestinal ulcerations; Vascular retinopathy; Recent intracranial or intracerebral haemorrhage; Intraspinal or intracerebral vascular abnormalities; Recent brain, spinal or ophthalmological surgery; Bronchiectasis or history of pulmonary bleeding.
Care should be taken if patients are treated concomitantly with drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other antithrombotics, or selective serotonin reuptake inhibitors (SSRI), and serotonin norepinephrine reuptake inhibitors (SNRls). For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered. Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site.
Surgery and intervention: If an invasive procedure or surgical intervention is required, rivaroxaban should be stopped at least 24 hours before the intervention, if possible and based on clinical judgment of the physician.
If the procedure cannot be delayed, the increased risk of bleeding should be assessed against the urgency of the intervention.
Rivaroxaban 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.
Neuraxial (epidural/spinal) Anesthesia: When neuraxial (epidural/spinal) anesthesia or spinal puncture is performed patients treated with antithrombotic for prevention of thromboembolic complications are at risk for development of an epidural or spinal hematoma which may result in long-term paralysis.
The risk of these events is even further increased by use of indwelling epidural catheters or the concomitant use of drugs affecting haemostasis. The risk may also be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological deficits are noted, urgent diagnosis and treatment is necessary.
The physician should consider the potential benefit versus the risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
An epidural catheter should not be withdrawn earlier than 18 hours in young adult patients and 26 hours in elderly patients after the last administration of rivaroxaban.
Rivaroxaban should be administered at earliest 6 hours after the removal of the catheter. If traumatic puncture occurs the administration of rivaroxaban should be delayed for 24 hours.
DVT and PE treatment in Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy: Rivaroxaban is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of rivaroxaban have not been established in these clinical situations.
Effects on ability to drive or use machines: Syncope and dizziness have been reported and may affect the ability to drive and use machines. Patients experiencing these adverse reactions should not drive or use machines.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.