Use In Patients With Hepatic Impairment
No clinical data are available for adult patients with severe hepatic impairment.
Avoid use of Xarelto in patients with moderate and severe hepatic impairment or with any hepatic disease associated with coagulopathy since drug exposure and bleeding risk may be increased .
No clinical data are available in pediatric patients with hepatic impairment.
Xarelto For Reducing The Risk Of Certain Complications From Blood Clots In People With Pad
Xarelto is FDA-approved to reduce the risk of certain complications from blood clots in people with peripheral artery disease .
Xarelto is taken in combination with aspirin. And it can be given to people whove recently had surgery to help with symptoms of PAD.
With PAD, you have narrowed arteries in your legs. This condition increases your risk of having blood clots. These clots can lead to heart attack, stroke, lack of blood flow in limbs, and possible need for amputation .
Xarelto is an anticoagulant . It reduces your risk of blood clots, which also reduces your risk of certain complications from blood clots.
Effectiveness for reducing the risk of certain complications of blood clots in people with PAD
One clinical study found that when Xarelto was taken with aspirin for 23 months, it was more effective than aspirin alone in reducing the risk of heart attack and stroke in people with PAD.
In fact, compared with people who took aspirin alone, people who took Xarelto plus aspirin were 29% less likely to have:
- heart attack
- death from a cardiovascular event
- limb injury due to reduced blood flow
Stay Safe While Taking Your Blood Thinner
You can be bleeding but not see any blood. For example, if you fall and hit your head, bleeding can occur inside your skull. Or, if you hurt your arm during a fall and then notice a large purple bruise, this means you are bleeding under your skin.
Because you are taking a blood thinner, you should try not to hurt yourself and cause bleeding. You need to be careful when you use knives, scissors, razors, or any sharp object that can make you bleed.
You also need to avoid activities and sports that could cause injury. Swimming and walking are safe activities. If you would like to start a new activity that will increase the amount of exercise you get every day, talk to your doctor.
You can still do many things that you enjoy. If you like to work in the yard, you still can. Just be sure to wear sturdy shoes and gloves to protect yourself. If you like to ride your bike, be sure you wear a helmet.
|Tell others.Keep a current list of all the medicines you take. Ask your doctor about whether you should wear a medical alert bracelet or necklace. If you are badly injured and unable to speak, the bracelet lets health care workers know that you are taking a blood thinner.|
To prevent injury indoors:
Xarelto For Reducing The Risk Of Stroke And Blood Clots In People With A
A-fib is a type of irregular heartbeat. It can disrupt the flow of blood around your body and increase your risk of having a blood clot. Blood clots can sometimes be dangerous. For example, a blood clot that travels to your brain can cause a stroke.
Xarelto is an anticoagulant . It lowers your risk of having strokes and blood clots.
Effectiveness for reducing the risk of stroke and blood clots in people with A-fib
In this study, 3.8% of people taking Xarelto had a stroke or blood clot. In comparison, 4.3% of patients taking warfarin had a stroke or blood clot.
Treatment Of Deep Vein Thrombosis And/or Pulmonary Embolism
EINSTEIN Deep Vein Thrombosis and EINSTEIN Pulmonary Embolism Studies
Xarelto for the treatment of DVT and/or PE was studied in EINSTEIN DVT and EINSTEIN PE , multi-national, open-label, non-inferiority studies comparing Xarelto to enoxaparin 1 mg/kg twice daily for at least five days with VKA and then continued with VKA only after the target INR was reached. Patients who required thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent and patients with creatinine clearance < 30 mL/min, significant liver disease, or active bleeding were excluded from the studies. The intended treatment duration was 3, 6, or 12 months based on investigator’s assessment prior to randomization.
In the EINSTEIN DVT and EINSTEIN PE studies, 49% of patients had an idiopathic DVT/PE at baseline. Other risk factors included previous episode of DVT/PE , recent surgery or trauma , immobilization , use of estrogen-containing drug , known thrombophilic conditions , or active cancer .
In the EINSTEIN DVT and EINSTEIN PE studies, Xarelto was demonstrated to be non-inferior to enoxaparin/VKA for the primary composite endpoint of time to first occurrence of recurrent DVT or non-fatal or fatal PE . In each study the conclusion of non-inferiority was based on the upper limit of the 95% confidence interval for the hazard ratio being less than 2.0.
Table 20 displays the overall results for the primary composite endpoint and its components for EINSTEIN DVT and EINSTEIN PE studies.
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What Are The Side Effects Of Xarelto
Get emergency medical help if you have signs of an allergic reaction: hives difficult breathing swelling of your face, lips, tongue, or throat.
Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.
Rivaroxaban can cause you to bleed more easily.
- easy bruising or bleeding
- pain, swelling, new drainage, or excessive bleeding from a wound or where a needle was injected in your skin
- any bleeding that will not stop
- headaches, dizziness, weakness, feeling like you might pass out
- urine that looks red, pink, or brown or
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Bleeding is the most common side effect of rivaroxaban.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Dosage For Reducing The Risk Of Recurrent Dvt Or Pe
Xarelto is used to reduce your risk of having another DVT or PE if:
- youve had at least 6 months of treatment for a DVT or PE with another anticoagulant drug, and
- youre still at risk of getting another blood clot
The usual dosage of Xarelto for reducing the risk of another DVT or PE is 10 mg taken once a day.
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What To Do In Case You Take Too Much Xarelto
Call your doctor if you think youve taken too much Xarelto. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or, go to the nearest emergency room.
Before you start Xarelto, discuss the medication with your doctor. Here are some examples of questions to help get you started:
- Can I take acetaminophen with Xarelto?
- How can I expect to feel if I stop taking Xarelto?
- If Xarelto isnt working for me, can my doctor increase my dose?
- What should I do if I become pregnant while taking this medication?
If youd like to learn more about common treatments for atrial fibrillation , read this article. You can also learn about treatment and recovery from deep vein thrombosis or pulmonary embolism . If youre taking Xarelto after surgery, you may want to read about how to prevent blood clots after surgery.
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Report A Janssen Product Quality Complaint
You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a product quality complaint.
Report a Janssen COVID-19 Vaccine Product Quality Complaint
Report a Product Quality Complaint to Janssen at 1-800-565-4008 or 1-908-455-9922 .
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Administration And Dosing Information
Xarelto comes in three different dosage forms and strengths, including 10-, 15- and 20-milligram tablets. The 10- and 15-milligram tablets are both round and red, with the weaker strength exhibiting a lighter red hue. The 20-milligram tablets are triangle-shaped and dark red.
For patients with atrial fibrillation , Xarelto is typically taken once a day with an evening meal. A patient taking Xarelto for the treatment of AF should never stop taking the medication without first talking to their doctor, as it can increase the risk of the individual having a stroke or forming blood clots in other parts of the body.
The recommended dose of Xarelto for the treatment of 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.
In patients taking Xarelto for prevention of deep vein thrombosis , which could result in pulmonary embolism following certain surgical procedures, the recommended daily dose is 10 milligrams taken once a day, with or without food. The initial dose should be taken at six to 10 hours after surgery once the patient has been stabilized .
Will I Need To Use This Drug Long Term
You might, but it depends on why youre taking Xarelto. The length of time Xarelto treatment is used is based on why youre taking the drug. Typical treatment lengths are as follows:
- If youre taking Xarelto after having a knee replacement, youll take the drug for 12 days after your surgery.
- If youre taking Xarelto after having a hip replacement, youll take the drug for 35 days after your surgery.
- If youre taking Xarelto because you were admitted to a hospital for an acute illness, youll take the drug for 31 to 39 days.
- If youre taking Xarelto to treat a deep vein thrombosis or pulmonary embolism , youll take the drug for 6 to 12 months.
However, when its prescribed to prevent blood clots or their complications, Xarelto is meant to be used as a long-term treatment. If you and your doctor determine that Xarelto is safe and effective for you, youll likely take it long term for these purposes.
With CAD, you have narrowed arteries in your heart. With PAD, you have narrowed arteries in your legs. Both of these conditions increase your risk of having blood clots that can cause a heart attack or stroke.
Using a combination of Xarelto and aspirin is more effective for preventing heart attack and stroke in people with CAD or PAD than using aspirin alone.
The recommended dosage of aspirin for this use is 75 mg to 100 mg taken once a day.
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Should I Take My Xarelto Doses With Food
The strength of Xarelto youre prescribed will determine whether you take the drug with food.
If youre prescribed the 2.5-milligram or 10-mg Xarelto tablets, youll take your doses with or without food. If youre prescribed the 15-mg or 20-mg Xarelto tablets, youll take each dose with food.
The dosage of Xarelto youre prescribed may depend on several factors. These include:
- the type and severity of the condition youre using Xarelto to treat
- other conditions you may have
Your reason for taking Xarelto and the strength youre prescribed will help determine how you take the drug.
Youll likely take Xarelto either once or twice each day.
For most conditions treated with a once-daily dose of Xarelto, you can take your dose at any time of day. Try to take it at the same time each day to keep consistent levels of the drug in your body.
If youre taking Xarelto because you have atrial fibrillation , you should take your once-daily dose with your evening meal.
For conditions that require taking Xarelto twice per day, you should take one dose in the morning and one in the evening. Generally, youll separate your morning and evening doses by about 12 hours. Try to take your doses at the same times each day.
If youre taking the 2.5-mg or 10-mg Xarelto tablets, you can take your dose with or without food. But if youre taking the 15-mg or 20-mg Xarelto tablets, you should take each dose with food.
If you have questions about how to take Xarelto, talk with your doctor.
Dosage Forms And Strengths
- 2.5 mg tablets: Round, light yellow, and film-coated with a triangle pointing down above a “2.5” marked on one side and “Xa” on the other side
- 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
- For oral suspension: white to off-white granules once reconstituted, provide flavored white to off-white opaque liquid with a concentration of 1 mg/mL.
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Xarelto For Preventing Vte In People Who Are Ill
Xarelto is FDA-approved to prevent venous thromboembolism in people who are admitted to a hospital with an acute medical illness. The drug is approved for this use in people who have an increased risk of blood clots, but who dont have a high risk of bleeding.
A VTE is a blood clot that forms in one of your veins . VTEs can travel throughout your body, including to your lungs. Youre at an increased risk of having a VTE if youre on bedrest or you cant move around very much.
Other risk factors for VTE include:
- having had a blood clot in the past
- a history of cancer
- a history of heart failure
- being 75 years of age or older
Xarelto is an anticoagulant . Its taken to prevent blood clots during your hospital stay. Youll also take it for a while after youre discharged from the hospital.
Effectiveness for preventing VTE in people who are ill
One clinical study compared treatment with Xarelto to treatment with enoxaparin for preventing VTE in people who were admitted to a hospital.
In this study, Xarelto was more effective than enoxaparin followed by a placebo in preventing blood clots in people admitted to the hospital.
After 10 days of treatment, 2.7% of people taking either Xarelto or enoxaparin had a blood clot.
Study Affirms Concomitant Use Associated With Major Hemorrhage
byNicole Lou, Staff Writer, MedPage Today June 8, 2020
One particular macrolide antibiotic was tied to higher bleeding risk in people taking direct oral anticoagulants , a study found.
Compared with azithromycin, patients prescribed a course of clarithromycin had a greater risk of 30-day hospital admission or emergency department visit with major hemorrhage , according to Manish Sood, MD, of The Ottawa Hospital in Ontario, and colleagues reporting online in JAMA Internal Medicine.
“These findings were consistent when a more broad-based definition for hemorrhage was used that included receipt of a blood transfusion, after excluding individuals with a history of H. pylori infection, using alternative methods of controlling for confounding , and limited to patients with known kidney function,” the authors noted.
A self-controlled case series analysis — comparing periods of exposure and non-exposure to antibiotics in people who had a hemorrhage — also found that these bleeds were associated with periods of clarithromycin use .
“Thus, the concurrent use of clarithromycin and DOACs poses a significant drug-drug interaction. Clinicians need to consider the risk of hemorrhage, the indication and microbial susceptibility of the infection being treated, and whether viable alternatives are readily available,” Sood’s group concluded.
Monitoring of DOAC levels may be necessary when patients use these drugs with clarithromycin, they suggested.
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How Does Xarelto Compare With Alternative Drugs Such As Pradaxa And Plavix
These medications are all taken by mouth. But they have different dosages, and different possible side effects and interactions. Before starting Xarelto, Pradaxa, or Plavix, talk with your doctor about the best treatment plan for you.
What Does Xarelto Cost
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use. To find current prices for Xarelto in your area, visit GoodRx.com.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Xarelto manufacturers website to see if they have support options. And you can check out this article to learn more about saving money on prescriptions.
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