NAME OF THE MEDICINAL PRODUCT
Rivarospire 10 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban micronized.
For a full list of excipients, see section 6.1.
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Posology and method of administration
The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established.
The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery.
• For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended.
• For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
If a dose is missed the patient should take Rivarospire immediately and then continue the following day with once daily intake as before.
Rivarospire can be taken with or without food.
No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) or moderate renal impairment (creatinine clearance 30 - 49 ml/min) (see section 5.2).
Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased in this patient population, therefore, Rivarospire is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min (see sections 4.4 and 5.2).
Rivarospire is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see sections 4.3 and 5.2). Rivarospire may be used with caution in cirrhotic patients with moderate hepatic impairment (Child Pugh B) if it is not associated with coagulopathy (see sections 4.4 and 5.2).
No dose adjustment is necessary in patients with other hepatic diseases.
No dose adjustment.
No dose adjustment.
No dose adjustment.
The safety and efficacy of Rivarospire in children 0 to 18 years have not been established. No data are available. Therefore, Rivarospire is not recommended for use in children below 18 years of age.
Method of administration
For oral use.
Hypersensitivity to the active substance or to any of the excipients.
Clinically significant active bleeding.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2).
Pregnancy and lactation (see section 4.6).
Pregnancy and lactation
No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility. Pregnancy
There are no adequate data from the use of rivaroxaban in pregnant women. Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
No data on the use of rivaroxaban in breast feeding women are available. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from therapy.
Effects on ability to drive and use machines
Syncope and dizziness have been reported in the post-operative setting and may affect the ability to drive and use machines, these adverse reactions have been reported to be uncommon (see section 4.8). Patients experiencing these adverse reactions should not drive or use machines.
Overdose following administration of rivaroxaban may lead to haemorrhagic complications due to its pharmacodynamic properties.
A specific antidote antagonising the pharmacodynamic effect of rivaroxaban is not available.
The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered.
Should bleeding occur, management of the haemorrhage may include the following steps:
• delay of next rivaroxaban administration or discontinuation of treatment as appropriate. Rivaroxaban has mean terminal half-lives between 7 and 11 hours (see section 5.2).
• appropriate symptomatic treatment, e.g. mechanical compression, surgical interventions, fluid replacement and haemodynamic support, blood product or component transfusion should be considered.
If life-threatening bleeding cannot be controlled by the above measures, administration of recombinant factor VIIa may be considered. However, there is currently no experience with the use of recombinant factor VIIa in individuals receiving rivaroxaban. The recommendation is based on limited non-clinical data. Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (e.g. desmopressin, aprotinin, tranexamic acid, aminocaproic acid) in individuals receiving rivaroxaban. Due to the high plasma protein binding rivaroxaban is not expected to be dialysable.