"Sept. 8, 2011 -- An FDA advisory panel has voted to recommend approval of a new blood thinner to prevent strokes and dangerous blood clots in patients with the heart rhythm disorder atrial fibrillation.
In a vote of nine to two, with "...
Reduction Of Risk Of Stroke And Systemic Embolism In Nonvalvular Atrial Fibrillation an
There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled[see Clinical Studies].
Treatment Of Deep Vein Thrombosis
Treatment Of Pulmonary Embolism
XARELTO is indicated for the treatment of pulmonary embolism (PE).
Reduction In The Risk Of Recurrence Of Deep Vein Thrombosis And Of Pulmonary Embolism
Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery
XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
DOSAGE AND ADMINISTRATION
|Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation||CrCl > 50 mL/min: 20 mg once daily with the evening meal|
|CrCl 15 to 50 mL/min: 15 mg once daily with the evening meal|
|Treatment of DVT
Treatment of PE
|15 mg twice daily with food, for first 21 days
Δ after 21 days, transition to Δ
20 mg once daily with food, for remaining treatment
|Reduction in the Risk of Recurrence of DVT and of PE||20 mg once daily with food|
|Prophylaxis of DVT Following Hip or Knee Replacement Surgery||Hip replacement: 10 mg once daily for 35 days|
|Knee replacement: 10 mg once daily for 12 days|
Important Food Effect Information
The 15 mg and 20 mg XARELTO tablets should be taken with food, while the 10 mg tablet can be taken with or without food[see CLINICAL PHARMACOLOGY].
In the nonvalvular atrial fibrillation efficacy study XARELTO was taken with the evening meal.
Switching To And From XARELTO
Switching from Warfarin to XARELTO
When switching patients from warfarin to XARELTO, discontinue warfarin and start XARELTO as soon as the International Normalized Ratio (INR) is below 3.0 to avoid periods of inadequate anticoagulation.
Switching from XARELTO to Warfarin
No clinical trial data are available to guide converting patients from XARELTO to warfarin. XARELTO affects INR, so INR measurements made during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue XARELTO and begin both a parenteral anticoagulant and warfarin at the time the next dose of XARELTO would have been taken.
Switching from XARELTO to Anticoagulants other than Warfarin
For patients currently taking XARELTO and transitioning to an anticoagulant with rapid onset, discontinue XARELTO and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next XARELTO dose would have been taken[see DRUG INTERACTIONS].
Switching from Anticoagulants other than Warfarin to XARELTO
For patients currently receiving an anticoagulant other than warfarin, start XARELTO 0 to 2 hours prior to the next scheduled evening administration of the drug (e.g., low molecular weight heparin or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start XARELTO at the same time.
Nonvalvular Atrial Fibrillation
For patients with creatinine clearance (CrCl) > 50 mL/min, the recommended dose of XARELTO is 20 mg taken orally once daily with the evening meal. For patients with CrCl 15 to 50 mL/min, the recommended dose is 15 mg once daily with the evening meal [see Use In Specific Populations].
Treatment Of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), And Reduction In The Risk Of Recurrence Of DVT And Of PE
The recommended dose of XARELTO for the initial treatment of acute DVT and/or PE is 15 mg taken orally twice daily with food for the first 21 days. After this initial treatment period, the recommended dose of XARELTO is 20 mg taken orally once daily with food, at approximately the same time each day. The recommended dose of XARELTO for reduction in the risk of recurrence of DVT or PE is 20 mg taken orally once daily with food at approximately the same time each day[see Clinical Studies].
Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery
The recommended dose of XARELTO is 10 mg taken orally once daily with or without food. The initial dose should be taken 6 to 10 hours after surgery provided that hemostasis has been established [see Discontinuation for Surgery and other Interventions].
- For patients undergoing hip replacement surgery, treatment duration of 35 days is recommended.
- For patients undergoing knee replacement surgery, treatment duration of 12 days is recommended.
Discontinuation For Surgery And Other Interventions
If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, XARELTO should be stopped at least 24 hours before the procedure to reduce the risk of bleeding an [see WARNINGS AND PRECAUTIONS]. In deciding whether a procedure should be delayed until 24 hours after the last dose of XARELTO, the increased risk of bleeding should be weighed against the urgency of intervention. XARELTO should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established, noting that the time to onset of therapeutic effect is short[see WARNINGS AND PRECAUTIONS]. If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
If a dose of XARELTO is not taken at the scheduled time, administer the dose as soon as possible on the same day as follows:
- For patients receiving 15 mg twice daily: The patient should take XARELTO immediately to ensure intake of 30 mg XARELTO per day. In this particular instance, 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.
- For patients receiving 20 mg, 15 mg or 10 mg once daily: The patient should take the missed XARELTO dose immediately.
For patients who are unable to swallow whole tablets, 10 mg, 15 mg or 20 mg XARELTO tablets may be crushed and mixed with applesauce immediately prior to use and administered orally. After the administration of a crushed XARELTO 15 mg or 20 mg tablet, the dose should be immediately followed by food [see CLINICAL PHARMACOLOGY].
Administration via nasogastric (NG) tube or gastric feeding tube: After confirming gastric placement of the tube, 10 mg, 15 mg or 20 mg XARELTO tablets may be crushed and suspended in 50 mL of water and administered via an NG tube or gastric feeding tube. Since rivaroxaban absorption is dependent on the site of drug release, avoid administration of XARELTO distal to the stomach which can result in reduced absorption and thereby, reduced drug exposure. After the administration of a crushed XARELTO 15 mg or 20 mg tablet, the dose should then be immediately followed by enteral feeding [see CLINICAL PHARMACOLOGY].
Crushed 10 mg, 15 mg or 20 mg XARELTO tablets are stable in water and in applesauce for up to 4 hours. Anin vitro compatibility study indicated that there is no adsorption of rivaroxaban from a water suspension of a crushed XARELTO tablet to PVC or silicone nasogastric (NG) tubing.
Dosage Forms And Strengths
- 10 mg tablets: Round, light red, biconvex and film-coated with a triangle pointing down above a “10” marked on one side and “Xa” on the other side
- 15 mg tablets: Round, red, biconvex, and film-coated with a triangle pointing down above a “15” marked on one side and “Xa” on the other side
- 20 mg tablets: Triangle-shaped, dark red, and film-coated with a triangle pointing down above a “20” marked on one side and “Xa” on the other side
Storage And Handling
XARELTO (rivaroxaban) Tablets are available in the strengths and packages listed below:
- 10 mg tablets are round, light red, biconvex film-coatan ed tablets marked with a triangle pointing down above a “10” on one side, and “Xa” on the other side. The tablets are supplied in the packages listed:
NDC 50458-580-30 Bottle
containing 30 tablets
NDC 50458-580-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
- 15 mg tablets are round, red, biconvex film-coated tablets with a triangle pointing down an above a “15” marked on one side and “Xa” on the other side. The tablets are supplied in the packages listed:
NDC 50458-578-30 Bottle
containing 30 tablets
NDC 50458-578-90 Bottle containing 90 tablets
NDC 50458-578-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
- 20 mg tablets are triangle-shaped, dark red film-coated tablets with a triangle pointing down above a “20” marked on one side and “Xa” on the other side. The tablets are supplied in the packages listed:
NDC 50458-579-30 Bottle containing 30 tablets
NDC 50458-579-90 Bottle containing 90 tablets
NDC 50458-579-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
Starter Pack for treatment of deep vein thrombosis and treatment of pulmonary embolism: NDC 50458-584-51 30-day starter blister pack containing 51 tablets: 42 tablets of 15 mg and 9 tablets of 20 mg
Store at 25 °C (77°F) or room temperature; excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.
Finished Product Manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 or Bayer Pharma AG 51368 Leverkusen, Germany. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Licensed from: Bayer HealthCare AG 51368 Leverkusen, Germany. Revised: June 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/25/2015
Additional Xarelto Information
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