Rivacryst Dosage/Direction for Use

Posology: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery (10 mg only): 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 Rivacryst immediately and then continue the following day with once daily intake as before.
Prevention of stroke and systemic embolism in adults (15 mg and 20 mg only): The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
Therapy with Rivacryst should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see Precautions).
If a dose is missed the patient should take Rivacryst immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE in adults: The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma). Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE.
When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily. In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Rivacryst 10 mg once daily, a dose of Rivacryst 20 mg once daily should be considered.
The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see Precautions). (See Table 9.)

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If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Rivacryst immediately to ensure intake of 30 mg Rivacryst per day. In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day.
If a dose is missed during the once daily treatment phase, the patient should take Rivacryst immediately, and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose.
Converting from Vitamin K Antagonists (VKA) to Rivacryst: Prevention of stroke and systemic embolism in adults (15 mg and 20 mg only): VKA treatment should be stopped and Rivacryst therapy should be initiated when the International Normalised Ratio (INR) is ≤ 3.0; Treatment of DVT, PE and prevention of recurrence in adults: VKA treatment should be stopped and Rivacryst therapy should be initiated once the INR is ≤ 2.5.
When converting patients from VKAs to Rivacryst, International Normalised Ratio (INR) values will be falsely elevated after the intake of Rivacryst. The INR is not valid to measure the anticoagulant activity of Rivacryst, and therefore should not be used (see Interactions).
Converting from Rivacryst to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Rivacryst to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivacryst can contribute to an elevated INR.
In patients converting from Rivacryst to VKA, VKA should be given concurrently until the INR is ≥ 2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing. While patients are on both Rivacryst and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Rivacryst. Once Rivacryst is discontinued INR testing may be done reliably at least 24 hours after the last dose (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Converting from parenteral anticoagulants to Rivacryst: For adult patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Rivacryst 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Converting from Rivacryst to parenteral anticoagulants: Discontinue Rivacryst and give the first dose of parenteral anticoagulant at the time the next Rivacryst dose would be taken.
Special populations: Renal impairment: Adults: Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased. Therefore, Rivacryst is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min (see Precautions and Pharmacology: Pharmacokinetics under Actions).
For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery (10 mg only), 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 Pharmacology: Pharmacokinetics under Actions).
For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (10 mg only), no dose adjustment from the recommended dose is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) (see Pharmacology: Pharmacokinetics under Actions).
In patients with moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15-29 ml/min) renal impairment the following dose recommendations apply: For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (15 mg and 20 mg only), the recommended dose is 15 mg once daily (see Pharmacology: Pharmacokinetics under Actions); For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE: patients should be treated with 15 mg twice daily for the first 3 weeks. Thereafter, when the recommended dose is 20 mg once daily, a reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patient's assessed risk for bleeding outweighs the risk for recurrent DVT and PE. The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see Precautions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.
No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) (see Pharmacology: Pharmacokinetics under Actions) (15 mg and 20 mg only).
Hepatic impairment: Rivacryst is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Elderly population: No dose adjustment (see Pharmacology: Pharmacokinetics under Actions).
Body weight: No dose adjustment (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose adjustment (see Pharmacology: Pharmacokinetics under Actions).
Patients undergoing cardioversion (15 mg and 20 mg only): Rivacryst can be initiated or continued in patients who may require cardioversion.
For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Rivacryst treatment should be started at least 4 hours before cardioversion to ensure adequate anticoagulation (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). For all patients, confirmation should be sought prior to cardioversion that the patient has taken Rivacryst as prescribed. Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Patients with non-valvular atrial fibrillation who undergo PCI (percutaneous coronary intervention) with stent placement (15 mg and 20 mg only): There is limited experience of a reduced dose of 15 mg Rivacryst once daily (or 10 mg Rivacryst once daily for patients with moderate renal impairment [creatinine clearance 30 - 49 ml/min]) in addition to a P2Y12 inhibitor for a maximum of 12 months in patients with non-valvular atrial fibrillation who require oral anticoagulation and undergo PCI with stent placement (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Paediatric population (10 mg only): The safety and efficacy of Rivacryst Tablets 10 mg in children aged 0 to 18 years have not been established. No data are available. Therefore, Rivacryst Tablets 10 mg are not recommended for use in children below 18 years of age.
Method of administration: Adults: Rivacryst is for oral use.
The tablets can be taken with or without food (see Interactions and Pharmacology: Pharmacokinetics under Actions) (10 mg only).
The tablets are to be taken with food (see Pharmacology: Pharmacokinetics under Actions) (15 mg and 20 mg only).
Crushing of tablets: For patients who are unable to swallow whole tablets, Rivacryst tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally. After the administration of crushed Rivacryst Tablets 15 mg or 20 mg, the dose should be immediately followed by food.
The crushed tablet may also be given through gastric tubes (see Pharmacology: Pharmacokinetics under Actions and Special precautions for disposal under Cautions for Usage).