Xarelto (rivaroxaban)
Xarelto® is a blood thinner that treats and prevents blood clots and lowers the risk of stroke in patients who have atrial fibrillation. It is a prescription medication in the Direct Xa Inhibitor drug class available in 10mg, 15mg, and 20mg tablets. Currently, there is no generic version available in the United States.
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Questions & Answers
Question
Will Xarelto have any negative side effects on newborns and nursing mothers?
Question
The medication can cause an increase in thrombotic occurrences.
Question
What is the percentage of patients with spinal deformity that experience side effects as a result of taking Xarelto?
Question
I was advised by my primary physician refrain from taking Warfarin will taking Xarelto.
Side Effects & Adverse Reactions
The U.S. Food and Drug Administration-approved labeling for XARELTO (rivaroxaban) contains the following warnings and precautions:
1. Increased risk of thrombotic events after premature discontinuation.
A patient should not stop taking XARELTO or any anticoagulant pill unless an adequate alternative medication has been prescribed, the patient has completed prescribed therapy or the patient is suffering from a serious and potentially fatal bleeding episode. It should be noted that, in clinical trials involving patients with nonvalvular atrial fibrillation, an increased risk of stroke was observed as patients switched from XARELTO to warfarin.2. Risk of bleeding.
XARELTO raises the risk of serious and potentially fatal bleeding events. In clinical trials, bleeding complications were the most commonly reported adverse reaction. A hemorrhage, or bleeding from ruptured blood vessels, is a type of a bleeding complication that can lead to stroke or death. The bleeding events reported in XARELTO clinical trials include:- Intracranial hemorrhage ñ Bleeding within the skull, or cranium, which may lead to brain cell/nerve damage, stroke or death. †Headaches, blurred vision, slurred speech, confusion and feelings of numbness, tingling or loss of control of one side of the body or face are signs of intracranial bleeding. Most XARELTO bleeding events involve this type of bleeding.
- Intraspinal hemorrhage ñ Bleeding within the spinal cord may lead to paralysis. A patient using XARELTO should seek medical help if he or she experiences weakness or loss of sensation in the limbs or experiences difficulties with urination.
- Gastrointestinal bleeding ñ Bleeding may occur in the upper (esophagus, stomach, upper portion of small intestine) or lower (large intestine, anus, rectum, bowels and lower portion of the small intestine) GI tracts. Signs of this bleeding include blood in the stool or urine, dark (tar-like) stool or vomiting blood (which looks like coffee grounds).
- Intraocular (eye)
- Pericardial (tissue surrounding the heart)
- Intra-articular (joints)
- Intramuscular (muscles)
- Retroperitoneal (abdomen).
3. Spinal/epidural anesthesia or puncture.
Pooling of blood (hematoma) may occur when spinal or epidural anesthesia is administered to a patient who is using XARELTO. The result may be long-term or permanent paralysis. For this reason, use of the anesthesia or the use of an epidural catheter should only take place when the anticoagulant effect of XARELTO is at its lowest. Also, a patient should be closely monitored for complications that include:- Back pain
- Numbness, tingling or weakness in the lower limbs
- Loss of bowel or bladder function.
4. Use in patients with renal impairment.
The use of an anticoagulant such as XARELTO is a concern with a patient suffering from renal impairment due to the fact that a patient may experience a loss of kidney function (or the filtering of waste products from the blood). Acute renal failure may be fatal.5. Use in patients with hepatic impairment.
A patient ís risk of experiencing a severe and potentially deadly bleeding episode while using XARELTO may be increased if the patient suffers from reduced functioning of the liver.6. Use with P-gp and strong CYP3A4 inhibitors or inducers.
XARELTO should not be used by patients who are also taking medications that either reduce or increase certain enzymes, including:- Ketoconazole and itraconazole (commonly prescribed antifungal medications)
- Lopinavir/ritonavir (a drug used to treat HIV infection)
- Conivaptan (a medication used to treat low blood sodium levels)
- Carbamazepine and phenytoin (anti-convulsants)
- Rifampin (a tuberculosis medication)
- St. Johnís wort (an herb often taken to treat depression).
7. Risk of pregnancy-related hemorrhage.
Doctors should fully weight the potential benefits of XARELTO use by pregnant women against the possible risks to the mother and fetus. In particular, the anticoagulant effect of XARELTO cannot be monitored through standard lab tests, and risks of severe bleeding may arise due to the inability to reverse the drugís anticoagulant effect.Patients with prosthetic heart valves.
The FDA has approved the use of XARELTO for the treatment of patients with non-heart valve-related atrial fibrillation. The manufacturer warns that no study has been undertaken of how XARELTO affects patients with artificial heart valves.9. Acute pulmonary embolism in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
XARELTO should not be administered to a patient with a blood clot in the lungs who is experiencing a significant drop in blood pressure and who will undergo emergency treatment for the condition. Sponsored by: Salvi, Schostok & Pritchard P.C.Legal Issues
In recent years, Xarelto has been marketed as a convenient alternative to Coumadin (warfarin). Xarelto users are free of the need for regular blood testing and dietary restrictions, several TV and print ads have touted. However, many believe these ads have failed to adequately warn consumers of the risks associated with Xarelto, including the risk of serious and potentially fatal gastrointestinal hemorrhaging and other excessive internal bleeding. Additionally, unlike a warfarin user, no antidote such as vitamin K injections exists to help a Xarelto user who experiences a bleeding emergency.
As a result, patients and those who have lost loved ones who were prescribed Xarelto have filed lawsuits in courts across the country against the companies behind Xarelto: Bayer HealthCare and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson). The lawsuits tend to allege that the Xarelto manufacturers failed to properly warn patients and doctors of the potential internal bleeding risks (and lack of an antidote) associated with the blood-thinning medication.
Individual Xarelto lawsuits that have been filed in federal courts have been transferred and consolidated in the U.S. District Court for the Eastern District of Louisiana. This helps to reduce the costs and time involved in pre-trial litigation. Lawsuits are also being filed in state courts.
The lawsuits are generally seeking compensatory damages (including compensation for all medical expenses) and punitive damages (which are meant to punish and deter grossly negligent or willful misconduct).
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
There is current no usage information for this drug.
History
There is currently no drug history available for this drug.
Other Information
Rivaroxaban, a FXa inhibitor, is the active ingredient in XARELTO Tablets with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is: Rivaroxaban is a pure Senantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media.Each XARELTO tablet contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 10 mg tablets is OpadryÆ Pink and for XARELTO 15 mg tablets is OpadryÆ Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is OpadryÆ II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.
Sources
Xarelto Manufacturers
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Cardinal Health
![Xarelto (Rivaroxaban) Tablet, Film Coated [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Xarelto | Cardinal Health
Indication DosageReduction in Risk of Stroke in Nonvalvular Atrial Fibrillation (2.3)
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 (2.4)
Treatment of PE (2.4)15 mg twice daily with food, for first 21 days
▼after 21 days, transition to ▼
20 mg once daily with food, for remaining treatment
Reduction in the Risk of Recurrence of DVT and of PE (2.4)
20 mg once daily with food
Prophylaxis of DVT Following Hip or Knee Replacement Surgery (2.5)
Hip replacement:
10 mg once daily for 35 days
Knee replacement:
10 mg once daily for 12 days
2.1 Important Food Effect InformationThe 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 (12.3)].
In the nonvalvular atrial fibrillation efficacy study XARELTO was taken with the evening meal.
2.2 Switching to and from XARELTOSwitching 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 (7.3)].
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.
2.3 Nonvalvular Atrial FibrillationFor 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 (8.7)].
2.4 Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PEThe 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 (14.2)].
2.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement SurgeryThe 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 Dosage and Administration (2.6)].
• 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. 2.6 Discontinuation for Surgery and other InterventionsIf 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 [see Warnings and Precautions (5.2)]. 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 (5.1)]. If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
2.7 Missed DoseIf 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. 2.8 Administration OptionsFor 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 Dosage and Administration (2.1, 2.3, 2.4) and Clinical Pharmacology (12.3)].
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 (12.3)].
Crushed 10 mg, 15 mg or 20 mg XARELTO tablets are stable in water and in applesauce for up to 4 hours. An in 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.
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Janssen Pharmaceuticals, Inc.
Xarelto | Janssen Pharmaceuticals, Inc.
Indication Dosage Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation (2.3) 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 (2.4)
Treatment of PE (2.4) 15 mg twice daily with food, for first 21 days ▼after 21 days, transition to ▼ 20 mg once daily with food, for remaining treatment Reduction in the Risk of Recurrence of DVT and of PE (2.4) 20 mg once daily with food Prophylaxis of DVT Following Hip or Knee Replacement Surgery (2.5) Hip replacement: 10 mg once daily for 35 days Knee replacement: 10 mg once daily for 12 days 2.1 Important Food Effect InformationThe 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 (12.3)].
In the nonvalvular atrial fibrillation efficacy study XARELTO was taken with the evening meal.
2.2 Switching to and from XARELTOSwitching 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 (7.3)].
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.
2.3 Nonvalvular Atrial FibrillationFor 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 (8.7)].
2.4 Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PEThe 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 (14.2)].
2.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement SurgeryThe 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 Dosage and Administration (2.6)].
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. 2.6 Discontinuation for Surgery and other InterventionsIf 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 [see Warnings and Precautions (5.2)]. 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 (5.1)]. If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
2.7 Missed DoseIf 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. 2.8 Administration OptionsFor 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 Dosage and Administration (2.1, 2.3, 2.4) and Clinical Pharmacology (12.3)].
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 (12.3)].
Crushed 10 mg, 15 mg or 20 mg XARELTO tablets are stable in water and in applesauce for up to 4 hours. An in 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.
![Xarelto (Rivaroxaban) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0e105f6-28f3-45ee-83bd-7d458835242b&name=image-01.jpg)
![Xarelto (Rivaroxaban) Tablet, Film Coated Xarelto (Rivaroxaban) Kit [Janssen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&name=xarelto-06.jpg)
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