Rivaxored Dosage/Direction for Use

Posology: 10 mg: 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 Rivaxored immediately and then continue the following day with once daily intake as before.
15 mg and 20 mg: Prevention of stroke and systemic embolism: The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
Therapy with Rivaxored 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 Rivaxored 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: 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, as indicated in the table as follows. (See Table 1.)

Click on icon to see table/diagram/image

The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see Precautions). Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
If a dose is missed during the 15 mg twice daily treatment phase (day 1-21), the patient should take Rivaxored immediately to ensure intake of 30 mg Rivaxored 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 (day 22 and onwards), the patient should take Rivaxored 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 Rivaxored: When converting patients from VKAs to Rivaxored, International Normalized Ratio (INR) values will be falsely elevated after the intake of Rivaxored. The INR is not valid to measure the anticoagulant activity of Rivaxored, and therefore should not be used (see Interactions).
15 mg and 20 mg: For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Rivaxored therapy should be initiated when the International Normalized Ratio (INR) is ≤3.0.
For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Rivaxored therapy should be initiated once the INR is ≤2.5.
Converting from Rivaxored to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Rivaxored to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaxored can contribute to an elevated INR.
In patients converting from Rivaxored 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 Rivaxored and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Rivaxored. Once Rivaxored 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 Rivaxored: For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Rivaxored 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 Rivaxored to parenteral anticoagulants: Give the first dose of parenteral anticoagulant at the time the next Rivaxored dose would be taken.
Special populations: Renal impairment: Limited clinical data for patients with severe renal impairment (creatinine clearance 15-29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased. Therefore, Rivaxored 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).
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) (for 10 mg) (see Pharmacology: Pharmacokinetics under Actions).
15 mg and 20 mg: In patients with moderate (creatinine clearance 30-49 ml/min) or severe (creatinine clearance 15-29 ml/min) renal impairment the following dosage recommendations apply: For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, 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, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.
Hepatic impairment: Rivaxored 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).
Paediatric population: The safety and efficacy of Rivaxored in children aged 0 to 18 years have not been established. No data are available. Therefore, Rivaxored is not recommended for use in children below 18 years of age.
15 mg and 20 mg: Patients undergoing cardioversion: Rivaxored can be initiated or continued in patients who may require cardioversion.
For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Rivaxored 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 Rivaxored 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: There is limited experience of a reduced dose of 15 mg Rivaxored once daily (or 10 mg Rivaxored 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).
Method of administration: For oral use.
10 mg: Rivaxored can be taken with or without food (see Interactions and Pharmacology: Pharmacokinetics under Actions).
15 mg and 20 mg: The tablets are to be taken with food (see Pharmacology: Pharmacokinetics under Actions).
For patients who are unable to swallow whole tablets, Rivaxored tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally. After the administration of crushed Rivaxored 15 mg or 20 mg film-coated tablets, the dose should be immediately followed by food.
The crushed Rivaxored tablet may also be given through gastric tubes after confirmation of the correct gastric placement of the tube. The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water. After the administration of crushed Rivaxored 15 mg or 20 mg film-coated tablets, the dose should then be immediately followed by enteral feeding (see Pharmacology: Pharmacokinetics under Actions).