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Xarelto®

Use of Concomitant Medications
The use of rivaroxaban is not recommended in patients receiving concomitant systemic treatment with azole antifungals (eg, ketoconazole) or HIV protease inhibitors (eg, ritonavir). These drugs are potent inhibitors of CYP3A4 and P-glycoprotein. Thus, these drugs may increase the plasma concentration of rivaroxaban to clinically significant levels (2.6-fold on average), which may lead to an increased risk of bleeding (see sections "Precautions", "Interactions with other drugs") .

However, the azole antifungal drug fluconazole, a moderate inhibitor of CYP3A4, has a less pronounced effect on the exposure of rivaroxaban and can be used concomitantly with it (see section "Interactions with other drugs").

Renal dysfunction

Rivaroxaban should be used with caution in patients with moderate renal impairment (CrCl 30-49 ml/min) receiving concomitant medications that may lead to increased plasma concentrations of rivaroxaban (see sections “With caution”, “Interaction with other drugs”). means").

In patients with severe renal impairment (CrCl < 30 ml/min), plasma concentrations of rivaroxaban may be significantly increased (1.6 times on average), which may lead to an increased risk of bleeding. Therefore, due to the presence of this underlying disease, such patients have an increased risk of developing both bleeding and thrombosis. Due to limited clinical data, rivaroxaban should be used with caution in patients with CrCl 15-29 ml/min.

There are no clinical data on the use of rivaroxaban in patients with severe renal impairment (CrCl <15 ml/min). Therefore, the use of Xarelto® is not recommended in such patients {see. sections “Contraindications”, “Method of administration and dosage”, “Pharmacological properties”). Patients with severe renal impairment (CrCl 15–29 mL/min), an increased risk of bleeding, or those receiving concomitant systemic treatment with azole antifungals or HIV protease inhibitors should be closely monitored for signs of bleeding after initiation of treatment.

Risk of bleeding

As with other anticoagulants, patients taking Xarelto should be carefully monitored for signs of bleeding.

In case of severe bleeding, Xarelto® should be discontinued.

In clinical studies, mucocutaneous bleeding (namely, bleeding from the nose, gums, gastrointestinal tract, genitourinary tract, including abnormal vaginal or increased menstrual bleeding) and anemia were observed more frequently during long-term treatment with rivaroxaban compared to VKA treatment. Thus, in addition to proper clinical monitoring, laboratory testing of hemoglobin/hematocrit may be useful in identifying occult bleeding and quantifying the clinical significance of overt bleeding that would be considered acceptable.

Xarelto®, like other antithrombotic agents, should be used with caution in patients at increased risk of bleeding, including:

patients with a congenital or acquired tendency to bleeding;
patients with uncontrolled severe arterial hypertension;
patients with gastric and duodenal ulcers in the acute stage;
patients who have recently suffered from gastric and duodenal ulcers;
patients with vascular retinopathy;
patients who have recently suffered intracranial or intracerebral hemorrhage;
patients with pathology of the blood vessels of the brain or spinal cord;
patients who have recently undergone surgery on the brain, spinal cord, or eyes;
patients with a history of bronchiectasis or pulmonary hemorrhage.

Caution should be exercised if the patient is concomitantly receiving medications that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, other antithrombotics, or selective serotonin reuptake inhibitors (SSRIs) and selective serotonin norepinephrine reuptake inhibitors (SNRIs). ) (see section “Interaction with other drugs”).

In patients at risk of developing gastric and duodenal ulcers, appropriate preventive treatment can be prescribed.

If there is an unexplained decrease in hemoglobin or blood pressure, it is necessary to look for the source of bleeding.

Rivaroxaban therapy does not require routine monitoring of its exposure.

However, measuring rivaroxaban concentrations using a calibrated test to quantify anti-Xa activity may be useful in exceptional cases where information about rivaroxaban exposure can be used to make clinically relevant decisions, such as in cases of overdose or emergency surgery.

Patients with artificial heart valves

Based on data from a randomized controlled clinical trial comparing Xarelto® therapy with antiplatelet therapy, Xarelto® is not recommended for the prevention of thrombosis in patients who have undergone recent transcatheter aortic valve replacement. The safety and effectiveness of Xarelto® have not been studied in patients with any other prosthetic heart valves or in patients undergoing other heart valve procedures; therefore, there is no data to support the use of Xarelto® 20 mg (15 mg in patients with moderate and severe renal impairment with ClCr 15-49 ml/min) provides a sufficient anticoagulant effect in these categories of patients.

Patients at high risk of triple positive antiphospholipid syndrome

The use of Xarelto® is not recommended in patients with a history of thrombosis who have been diagnosed with persistent triple positive antiphospholipid syndrome (the presence of lupus anticoagulant, antibodies to cardiolipin and antibodies to beta-2-glycoprotein I), since therapy with rivaroxaban is accompanied by an increased incidence of recurrent thrombotic events compared with vitamin K antagonist (VKA) therapy.

Patients with non-valvular atrial fibrillation who underwent PCI with stenting

There are data from an international clinical trial, the primary purpose of which was to evaluate safety in patients with non-valvular atrial fibrillation who underwent PCI with stenting. Data on effectiveness in this population are limited (see section "Dosage and Administration"). There are no data available for such patients with a history of stroke/transient ischemic attack.

Patients with hemodynamically unstable pulmonary embolism (PE) and patients requiring thrombolysis or thrombectomy

Rivaroxaban is not recommended as an alternative to unfractionated heparin in patients with hemodynamically unstable pulmonary embolism or in patients who may require thrombolysis or thrombectomy, since the safety and effectiveness of Xarelto in these clinical situations has not been established.

Surgical operations and interventions

If an invasive procedure or surgery is necessary, Xarelto® should be discontinued at least 24 hours before the procedure and based on the doctor's opinion.

If the procedure cannot be delayed, the increased risk of bleeding should be weighed against the need for urgent intervention.

Xarelto® should be restarted after an invasive procedure or surgery, provided that appropriate clinical indicators and adequate hemostasis are present (see section "Pharmacological properties").

Spinal anesthesia

When performing epidural/spinal anesthesia or spinal puncture in patients receiving platelet aggregation inhibitors to prevent thromboembolic complications, there is a risk of developing an epidural or spinal hematoma, which can lead to prolonged paralysis. The risk of these events is further increased by the use of an indwelling epidural catheter or concomitant therapy with drugs that affect hemostasis. Traumatic epidural or spinal puncture or repeat puncture may also increase the risk.

Patients should be monitored for signs and symptoms of neurological impairment (eg, numbness or weakness of the legs, bowel or bladder dysfunction). If neurological disorders are detected, urgent diagnosis and treatment are necessary.

The physician should weigh the potential benefit against the relative risk before performing spinal surgery in patients receiving anticoagulants or who are scheduled to receive anticoagulants for the purpose of preventing thrombosis. There is no clinical experience with the use of rivaroxaban in dosages of 15 mg and 20 mg in the situations described.

To reduce the potential risk of bleeding associated with concomitant use of rivaroxaban and epidural/spinal anesthesia or spinal puncture, the pharmacokinetic profile of rivaroxaban should be considered. Insertion or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is assessed as weak.

However, the exact time to achieve a sufficiently low anticoagulant effect in each patient is unknown. Based on general pharmacokinetic characteristics, the epidural catheter is removed after at least 2 times the elimination half-life, i.e. no earlier than 18 hours after the last dose of Xarelto® for young patients and no earlier than 26 hours for older patients. Xarelto® should be prescribed no earlier than 6 hours after removal of the epidural catheter.

In the event of a traumatic puncture, the administration of Xarelto® should be postponed for 24 hours.

Skin reactions

Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during post-marketing surveillance. At the first appearance of a severe skin rash (eg, if it spreads, intensifies and/or blisters), or if other mucosal hypersensitivity symptoms occur, Xarelto therapy should be discontinued.

Women of reproductive age

Xarelto® should only be used by women of childbearing age if they are using effective contraception.

Corrected QT interval prolongation

There was no effect of Xarelto® on the duration of the QT interval.

Safety data obtained from nonclinical studies

With the exception of effects associated with enhanced pharmacological action (bleeding), analysis of preclinical data obtained in pharmacological safety studies did not reveal any specific hazard to humans.