Vebroz Dosage/Direction for Use

Treatment and prevention of recurrent DVT and PE - Dosage and method of administration: Treatment and prevention of recurrent DVT and PE: Method of administration: Oral use.
Treatment and prevention of recurrent DVT and PE: Recommended usual dose: The recommended dose for the initial treatment of acute DVT and PE is Rivaroxaban 15 mg twice daily for the first three weeks followed by Rivaroxaban 20 mg once daily for the continued treatment and the prevention of recurrent DVT and PE.
Following completion of at least 6 months treatment for DVT or PE, Rivaroxaban 10 mg once daily or Rivaroxaban 20 mg once daily is recommended based on an individual assessment of the risk of recurrent DVT or PE against the risk for bleeding. (See Table 9.)

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10 mg: VTE prevention - Dosage and method of administration: VTE prevention: Method of administration: Oral use.
VTE prevention: Recommended usual dose: The recommended dose for VTE prevention in major orthopedic surgery is one 10 mg tablet once daily.
VTE prevention: Duration of treatment: After major hip surgery patients should be treated for 5 weeks.
After major knee surgery patients should be treated for 2 weeks.
VTE prevention: Method and frequency of administration: One 10 mg tablet of Rivaroxaban should be taken once daily.
Rivaroxaban 10 mg tablets may be taken with or without food.
The initial dose should be taken within 6-10 hours after surgery provided that hemostasis has been established. For patients who are unable to swallow whole tablets, Rivaroxaban tablet may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally.
The crushed Rivaroxaban tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Rivaroxaban. The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water.
VTE prevention: Missed dose: If a dose is missed the patient should take the 10 mg Rivaroxaban dose immediately and continue on the following day with the once daily intake as before.
Additional information on special populations: Patients with hepatic impairment: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases.
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity. No clinical data are available for patients with severe hepatic impairment.
Patients with renal impairment: No dose adjustment is required if Rivaroxaban is administered in patients with mild or moderate renal impairment.
Limited clinical data for patients with severe renal impairment indicate that Rivaroxaban plasma levels are significantly increased in this patient population.
Therefore, Rivaroxaban must be used with caution in these patients.
Use of Rivaroxaban is not recommended in patients with CrC <15 ml/min.
Converting from Vitamin K Antagonists (VKA) to Rivaroxaban: When converting patients from VKAs to Rivaroxaban, INR values will be falsely elevated after the intake of Rivaroxaban. The INR is not valid to measure the anticoagulant activity of Rivaroxaban, and therefore should did to measure the anticoagulant seivity of Riva not be used.
Converting from Rivaroxaban to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Rivaroxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaroxaban can contribute to an elevated INR.
In patients converting from Rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥ 2.0. For the first two days of the conversion period, standard VKA dosing should be used followed by VKA dosing guided by INR testing. While patients are on both Rivaroxaban and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of Rivaroxaban. Once Rivaroxaban is discontinued INR testing may be done reliably 24 hours after the last dose.
Converting from parenteral anti-coagulants to Rivaroxaban: For patients currently receiving a parenteral anticoagulant, start Rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral drug (e.g. LMWH) or at the time of discontinuation of a continuously administered parenteral drug (e.g. intravenous unfractionated heparin).
Converting from Rivaroxaban to parenteral anti-coagulants: Discontinue Rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next Rivaroxaban dose would be taken.
Children and adolescents (from birth to 16 or 18 years depending on local law): Safety and efficacy have not been established in children and adolescents below l8 years.
Geriatric patients: No dose adjustment is required based on age.
Gender: No dose adjustment is required based on gender.
Body weight: No dose adjustment is required based on body weight.
Ethnic differences: No dose adjustment is required based on ethnic differences.
Treatment and prevention of recurrent DVT and PE: Duration of treatment: Therapy should be continued as long as the VTE risk persist.
15 mg and 20 mg: SPAF - Dosage and method of administration: SPAF: Method of administration: Oral use.
SPAF: Recommended usual dose: The recommended dose is 20 mg once daily.
For patients with moderate renal impairment (creatinine clearance (CrC): <50-30 mL/min) the recommend dose is 15 mg once daily.
SPAF: Method and frequency of administration: One 20 mg tablet of Rivaroxaban should be taken once daily.
For patients with moderate renal impairment (CrC: <50-30 mL/min) one 15 mg tablet of Rivaroxaban should be taken once daily.
Rivaroxaban 15 mg tablets and Rivaroxaban 20 mg tablets should be taken with food.
For patients who are unable to swallow whole tablets, Rivaroxaban tablet may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally. After the administration of crushed 15 mg or Rivaroxaban 20 mg tablets, the dose should be immediately followed by food.
The crushed Rivaroxaban tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Rivaroxaban. 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 Rivaroxaban 15 mg or 20 mg tablets, the dose should then be immediately followed by enteral feeding.
SPAF: Missed Dose: If a dose is missed the patient should take Rivaroxaban immediately and continue with the once daily intake as recommended on the following day.
The dose should not be doubled to make up for a missed dose within the same day.
SPAF: Maximum daily dose: The recommended maximum daily dose is 20 mg.
SPAF: Additional information on special populations: SPAF: Patients with hepatic impairment: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases.
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity. No clinical data are available for patients with severe hepatic impairment.
SPAF: Patients with renal impairment: No dose adjustment is required if Rivaroxaban is administered in patients with mild renal impairment.
For patients with moderate renal impairment the recommended dose is 15 mg once daily.
Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma levels are significantly increased in this patient population. Therefore, Rivaroxaban 15 mg must be used with caution in these patients.
Use of Rivaroxaban is not recommended in patients with CrC <15 ml/min.
SPAF: Converting from Vitamin K Antagonists (VKA) to Rivaroxaban: VKA treatment should be stopped and Rivaroxaban therapy should be initiated when the INR is ≤ 3.0.
When converting patients from VKAs to Rivaroxaban, INR values will be falsely elevated after the intake of Rivaroxaban. The INR is not valid to measure the anticoagulant activity of Rivaroxaban, and therefore should not be used.
SPAF: Converting from Rivaroxaban to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Rivaroxaban to VKA.
Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
It should be noted that Rivaroxaban can contribute to an elevated INR.
In patients converting from Rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0. For the first two days of the conversion period, standard VKA dosing should be used followed by VKA dosing guided by INR testing. While patients are on both Rivaroxaban and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of Rivaroxaban. Once Rivaroxaban is discontinued INR testing may be done reliably 24 hours after the last dose.
SPAF: Converting from parenteral anti-coagulants to Rivaroxaban: For patients currently receiving a parenteral anticoagulant, start Rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral drug (e.g. LMWH) or at the time of discontinuation of a continuously administered parenteral drug (e.g. intravenous unfractionated heparin).
SPAF: Converting from Rivaroxaban to parenteral anti-coagulants: Discontinue Rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next Rivaroxaban dose would be taken.
SPAF: Cardioversion: Rivaroxaban can be initiated or continued in patients who may require cardioversion.
For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Rivaroxaban treatment should be started at least 4 hours before cardioversion to ensure adequate anticoagulation.
SPAF: Patients who undergo PCI (percutaneous coronary intervention) with stent placement: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement should receive reduced dose of 15 mg Rivaroxaban once daily (or 10 mg Rivaroxaban once daily for patients with moderate renal impairment [CrCI: <50-30 ml/min]) in addition to a P2Y12 inhibitor. This treatment regimen is recommended for a maximum of 12 months after PCI with stent placement.
After completion of the antiplatelet therapy, rivaroxaban dosage should be increased to the standard dose for patients with non-valvular atrial fibrillation.
SPAF: Children and adolescents (from birth to 16 or 18 years depending on local law): Safety and efficacy have not been established in children and adolescents below 18 years.
SPAF: Geriatric patients: No dose adjustment is required based on age.
SPAF: Gender: No dose adjustment is required based on gender.
SPAF: Body weight: No dose adjustment is required based on body weight.
SPAF: Ethnic differences: No dose adjustment is required based on ethnic differences.
Treatment and prevention of recurrent DVT and PE: Method and frequency of administration: During the initial 3 weeks of acute treatment 15 mg of Rivaroxaban should be taken twice daily.
After the initial 3 weeks treatment Rivaroxaban should be continued at 20 mg once daily.
After at least 6 months treatment Rivaroxaban should be taken at 10 mg once daily or 20 mg once daily.
Rivaroxaban 15 mg tablets and Rivaroxaban 20 mg tablets should be taken with food.
For patients who are unable to swallow whole tablets, Rivaroxaban tablet may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally. After the administration of crushed Rivaroxaban 15 mg or Rivaroxaban 20 mg tablets, the dose should be immediately followed by food.
The crushed Rivaroxaban tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Rivaroxaban. 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 Rivaroxaban 15 mg or 20 mg tablets, the dose should then be immediately followed by enteral feeding.
Treatment and prevention of recurrent DVT and PE: Missed Dose: It is essential to adhere to the dosage schedule provided.
If a dose is missed during the 15 mg twice daily treatment phase the patient should take Rivaroxaban immediately to ensure intake of 30 mg Rivaroxaban 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 Rivaroxaban immediately to ensure intake of the recommended daily dose. The patient should continue with the regular once daily dose as recommended on the following day.
Treatment and prevention of recurrent DVT and PE: Maximum daily dose: The recommended maximum daily dose is 30 mg during the first 3 weeks of treatment. In the following treatment phase the recommended maximum daily dose is 20 mg.
Treatment and prevention of recurrent DVT and PE: Additional information on special populations: Treatment and prevention of recurrent DVT and PE: Patients with hepatic impairment: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases.
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity.
No clinical data are available for patients with severe hepatic impairment.
Treatment and prevention of recurrent DVT and PE: Patients with renal impairment: No dose adjustment is required if Rivaroxaban is administered in patients with mild or moderate renal impairment.
Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma levels are significantly increased in this patient population. Therefore Rivaroxaban must be used with caution in these patients.
Use of Rivaroxaban is not recommended in patients with CrC: <15 ml/min.
Treatment and prevention of recurrent DVT and PE: Converting from Vitamin K Antagonists (VKA) to Rivaroxaban: VKA treatment should be stopped and Rivaroxaban therapy should be initiated once the INR is ≤ 2.5. When converting patients from VKAs to Rivaroxaban, INR values will be falsely elevated after the intake of Rivaroxaban. The INR is not valid to measure the anticoagulant activity of Rivaroxaban, and therefore should not be used.
Treatment and prevention of recurrent DVT and PE: Converting from Rivaroxaban to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Rivaroxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaroxaban can contribute to an elevated INR.
In patients converting from Rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0. For the first two days of the conversion period, standard VKA dosing should be used followed by VKA dosing guided by INR testing.
While patients are on both Rivaroxaban and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of Rivaroxaban). Once Rivaroxaban is discontinued INR testing may be done reliably 24 hours after the last dose.
Treatment and prevention of recurrent DVT and PE: Converting from parenteral anti-coagulants to Rivaroxaban: For patients currently receiving a parenteral anticoagulant, start Rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral drug (e.g. LMWH) or at the time of discontinuation of a continuously administered parenteral drug (e.g. intravenous unfractionated heparin).
Treatment and prevention of recurrent DVT and PE: Converting from Rivaroxaban to parenteral anti-coagulants: Discontinue Rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next Rivaroxaban dose would be taken.
Treatment and prevention of recurrent DVT and PE: Children and adolescents (from birth to 16 or 18 years depending on local law): Safety and efficacy have not been established in children and adolescents below 18 years.
Treatment and prevention of recurrent DVT and PE: Geriatric patients: No dose adjustment is required based on age.
Treatment and prevention of recurrent DVT and PE: Gender: No dose adjustment is required based on gender.
Treatment and prevention of recurrent DVT and PE: Body weight: No dose adjustment is required based on body weight.
Treatment and prevention of recurrent DVT and PE: Ethnic differences: No dose adjustment is required based on ethnic differences.