Xarelto Dosage/Direction for Use

VTE Treatment: Recommended Dose: Initial Treatment of Acute DVT: 15 mg twice daily for the 1st 3 weeks followed by 20 mg once daily for the continued treatment and the prevention of recurrent DVT and PE.
VTE Prevention in Major Orthopedic Surgery: Recommended Dose: 10 mg taken once daily. Duration of Treatment: After major hip surgery: 5 weeks; major knee surgery: 2 weeks.
Rivaroxaban may be taken with or without food. The initial dose should be taken 6-10 hrs after surgery provided that hemostasis has been established. If a dose is missed, the patient should take rivaroxaban immediately and continue on the following day with the once-daily intake as before.
Special Populations: Elderly >65 years, Gender and Body Weight: No dose adjustment is required for these patient populations (see Pharmacokinetics under Actions).
Children (From Birth to 16 or 18 years Depending on Local Law): No clinical data available in children.
Patients with Impaired Liver Function: 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 (see Pharmacology: Pharmacokinetics under Actions).
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 (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Patients with Impaired Renal Function: No dose adjustment is required if rivaroxaban is administered in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions).
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 CrCl <15 mL/min (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Ethnic Differences: No dose adjustment is required based on ethnic differences (see Pharmacokinetics under Actions).
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 recommended dose is 15 mg once daily.
SPAF: Method and frequency of administration: One 20 mg tablet of Xarelto should be taken once daily.
For patients with moderate renal impairment (CrC: <50-30 mL/min) one 15 mg tablet of Xarelto should be taken once daily.
Xarelto 15 mg tablets and Xarelto 20 mg tablets should be taken with food.
For patients who are unable to swallow whole tablets, Xarelto 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 Xarelto 15 mg or Xarelto 20 mg tablets, the dose should be immediately followed by food.
The crushed Xarelto tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Xarelto. 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 Xarelto 15 mg or 20 mg tablets, the dose should then be immediately followed by enteral feeding (see 'Pharmacology: Pharmacokinetics under Actions').
SPAF: Missed Dose: If a dose is missed the patient should take Xarelto 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: Xarelto is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk (see 'Contraindications').
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 (see 'Contraindications').
SPAF: Patients with renal impairment: No dose adjustment is required if Xarelto 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, Xarelto 15 mg must be used with caution in these patients (see 'Precautions').
Use of Xarelto is not recommended in patients with CrC <15 mL/min (see 'Precautions').
SPAF: Converting from Vitamin K Antagonists (VKA) to Xarelto: VKA treatment should be stopped and Xarelto therapy should be initiated when the INR is ≤ 3.0. When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see 'Interactions').
SPAF: Converting from Xarelto to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Xarelto can contribute to an elevated INR.
In patients converting from Xarelto 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 Xarelto and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably 24 hours after the last dose (see 'Interactions').
SPAF: Converting from parenteral anti-coagulants to Xarelto: For patients currently receiving a parenteral anticoagulant, start Xarelto 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 Xarelto to parenteral anti-coagulants: Discontinue Xarelto and give the first dose of parenteral anticoagulant at the time that the next Xarelto dose would be taken.
SPAF: Cardioversion: Xarelto can be initiated or continued in patients who may require cardioversion.
For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Xarelto 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 Xarelto once daily (or 10 mg Xarelto once daily for patients with moderate renal impairment [CrCl: <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 (see 'Precautions' and 'Pharmacology: Pharmacodynamics under Actions'). 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 - 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 Xarelto 15 mg twice daily for the first three weeks followed by Xarelto 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, Xarelto 10 mg once daily or Xarelto 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 6.)

Click on icon to see table/diagram/image

Treatment and prevention of recurrent DVT and PE: Method and frequency of administration: During the initial 3 weeks of acute treatment 15 mg of Xarelto should be taken twice daily. After the initial 3 weeks treatment Xarelto should be continued at 20 mg once daily.
After at least 6 months treatment Xarelto should be taken at 10 mg once daily or 20 mg once daily.
Xarelto 15 mg tablets and Xarelto 20 mg tablets should be taken with food.
For patients who are unable to swallow whole tablets, Xarelto 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 Xarelto 15 mg or Xarelto 20 mg tablets, the dose should be immediately followed by food.
The crushed Xarelto tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Xarelto. 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 Xarelto 15 mg or 20 mg tablets, the dose should then be immediately followed by enteral feeding (see 'Pharmacology: Pharmacokinetics under Actions').
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 Xarelto immediately to ensure intake of 30 mg Xarelto 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 Xarelto 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: Xarelto is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk (see 'Contraindications').
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 (see 'Contraindications').
Treatment and prevention of recurrent DVT and PE: Patients with renal impairment: No dose adjustment is required if Xarelto 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 Xarelto must be used with caution in these patients (see 'Precautions').
Use of Xarelto is not recommended in patients with CrC: <15 mL/min (see 'Precautions').
Treatment and prevention of recurrent DVT and PE: Converting from Vitamin K Antagonists (VKA) to Xarelto: VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.
When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see 'Interactions').
Treatment and prevention of recurrent DVT and PE: Converting from Xarelto to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Xarelto can contribute to an elevated INR.
In patients converting from Xarelto 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 Xarelto and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably 24 hours after the last dose (see 'Interactions').
Treatment and prevention of recurrent DVT and PE: Converting from parenteral anti-coagulants to Xarelto: For patients currently receiving a parenteral anticoagulant, start Xarelto 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 Xarelto to parenteral anti-coagulants: Discontinue Xarelto and give the first dose of parenteral anticoagulant at the time that the next Xarelto 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.