Xarelto

• Xarelto^®

Xarelto is a prescription medication used to prevent certain types of blood clots and strokes. Xarelto can be used in people who are having hip or knee replacement surgery, and for people with an irregular heart rhythm.

Xarelto , a "blood thinner", belongs to a group of drugs called factor Xa inhibitors. Factor Xa is an enzyme required for blood to clot. Xarelto inhibits factor Xa, slowing down blood clot formation.

This medication comes in tablet form and is usually taken once daily, with or without food. For people taking it for atrial fibrillation (irregular heart rhythm), Xarelto is taken once daily with the evening meal.

Common side effects include itching, muscle spasms, and bleeding.

Xarelto is a prescription medicine used in adults to:

• reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body.
• reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.
• treat and reduce the recurrence of blood clots in the legs [deep vein thrombosis (DVT)]
• treat and reduce the recurrence of blood clots in the lungs [pulmonary embolism (PE)]

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Xarelto can cause bleeding, which can be serious, and rarely may lead to death. See "Drug Precautions".

Xarelto may cause other side effects. Discuss any side effects with your doctor.

• People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Xarelto lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking Xarelto, you may have increased risk of forming a clot in your blood. Do not stop taking Xarelto without talking to the doctor who prescribes it for you. Stopping Xarelto  increases your risk of having a stroke. If you have to stop taking Xarelto, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
• Xarelto can cause bleeding which can be serious, and rarely may lead to death. This is because Xarelto is a blood thinner medicine that reduces blood clotting. While you take Xarelto you are likely to bruise more easily and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take Xarelto and take other medicines that increase your risk of bleeding.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

• unexpected bleeding or bleeding that lasts a long time
• nose bleeds that happen often
• unusual bleeding from the gums
• menstrual bleeding that is heavier than normal or vaginal bleeding
• bleeding that is severe or you cannot control
• red, pink or brown urine
• bright red or black stools (looks like tar)
• cough up blood or blood clots
• vomit blood or your vomit looks like "coffee grounds"
• headaches, feeling dizzy or weak
• pain, swelling, or new drainage at wound sites

Do not take Xarelto if you:

• currently have certain types of abnormal bleeding. Talk to your doctor before taking Xarelto if you currently have unusual bleeding.
• are allergic to Xarelto or any of the ingredients in it.

Grapefruit and grapefruit juice may interact with Xarelto and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

You should not use this medicine if you have an artificial heart valve, or if you have active or uncontrolled bleeding.

Rivaroxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Do not stop taking rivaroxaban without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

If you take rivaroxaban 1 time each day: Take the missed dose as soon as you remember. Take your next dose the following day and stay on your once-daily schedule. Do not take extra medicine to make up the missed dose.

If you take rivaroxaban 2 times each day: Take the missed dose as soon as you remember. You may take 2 doses at the same time to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause excessive bleeding.

Anticoagulant; an oral, direct, activated factor X (Xa) inhibitor.1 2 3 4 5 7 8 9 12 16 17 18 20 32 33

Rivaroxaban is used to treat and prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip or knee replacement surgery while you are unable to walk. It is during this time that blood clots are most likely to form.

Rivaroxaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problem (eg, nonvalvular atrial fibrillation).

Rivaroxaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rivaroxaban in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivaroxaban in the elderly. However, elderly patients are more likely to have bleeding and blood clotting problems and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving rivaroxaban.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Carbamazepine
• Celecoxib
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Collagenase, Clostridium histolyticum
• Conivaptan
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Darunavir
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Duloxetine
• Edoxaban
• Eliglustat
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenofibrate
• Fenofibric Acid
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibuprofen
• Iloprost
• Indinavir
• Indomethacin
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reteplase, Recombinant
• Rifampin
• Ritonavir
• Rofecoxib
• Selexipag
• Sertraline
• Sibutramine
• Simeprevir
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Telaprevir
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Treprostinil
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood vessel problems or
• Catheter insertion in the spine or
• Liver disease, moderate and severe or
• Stomach or intestinal ulcer or bleeding or
• Stroke, recent or history of or
• Surgery (eg, eye, brain, spine), recent or history of—Use with caution. The risk of bleeding may be increased.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Major bleeding, active or
• Prosthetic heart valve—Should not be used in patients with this condition.

• 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

NDC 50458-580-30
30 Tablets

Xarelto®
(rivaroxaban)
Tablets
10 mg

Dispense the accompanying
Medication Guide to each patient.

janssen

Rx only

You should not use Xarelto if you are allergic to rivaroxaban, or if you have:

• an artificial heart valve; or

• active or uncontrolled bleeding.

Xarelto can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if you have:

• you have a genetic spinal defect;

• you have a spinal catheter in place;

• you have a history of spinal surgery or repeated spinal taps;

• you have recently had a spinal tap or epidural anesthesia;

• you are taking an NSAID - Advil, Aleve, Motrin, and others; or

• you are using other medicines to treat or prevent blood clots.

Xarelto may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;

• hemorrhagic stroke;

• uncontrolled high blood pressure;

• stomach or intestinal bleeding or ulcer; or

• if you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), or clopidogrel (Plavix), or certain antidepressants.

To make sure you can safely take Xarelto, tell your doctor if you have kidney or liver disease.

It is not known whether Xarelto will harm an unborn baby. However, this medicine could cause bleeding complications during childbirth. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rivaroxaban passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Xarelto.

Usual Adult Dose of Xarelto for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery:

Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery:
10 mg orally once a day starting 6 to 10 hours after surgery.

Duration of therapy is 35 days for hip replacement surgery and 12 days for knee replacement surgery.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery:

Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery:
10 mg orally once a day starting 6 to 10 hours after surgery.

Duration of therapy is 35 days for hip replacement surgery and 12 days for knee replacement surgery.

Usual Adult Dose for Atrial Fibrillation:

Nonvalvular Atrial Fibrillation:
20 mg orally, once daily with the evening meal.

Usual Adult Dose of Xarelto for Deep Vein Thrombosis:

Treatment of DVT and PE:
Initial dose: 15 mg orally twice daily with food, for first 21 days.
Maintenance dose: 20 mg orally once daily with food, for remaining treatment.

Usual Adult Dose for Pulmonary Embolism:

Treatment of DVT and PE:
Initial dose: 15 mg orally twice daily with food, for first 21 days.
Maintenance dose: 20 mg orally once daily with food, for remaining treatment.

Usual Adult Dose for Deep Vein Thrombosis - Recurrent Event:

Reduction in the Risk of Recurrence of DVT and of PE:
20 mg orally once daily with food.

Usual Adult Dose of Xarelto for Pulmonary Embolism - Recurrent Event:

Reduction in the Risk of Recurrence of DVT and of PE:
20 mg orally once daily with food.

Xarelto limits the ability of the blood to clot and is effective at treating or preventing conditions where the risk of blood clotting is high (such as atrial fibrillation, DVT, PE); however, it may cause severe bleeding and there is currently no antidote to reverse this bleeding.

• Take the 15mg and 20mg tablets with food. The 10mg tablet can be taken with or without food. May be taken with the evening meal.
• Take exactly as directed by your doctor. If you miss a dose and you take Xarelto once daily, take as soon as you remember, but do not double up the dose if you don't remember until the next day.
• Tablets may be crushed and mixed with applesauce immediately prior to use in people who have difficulty swallowing. Follow up the dose with food.
• Avoid any activities that may increase your risk of bleeding or injury. Be careful when shaving or brushing your teeth.
• Do not stop suddenly without your doctor's advice as this increases the risk of blood clots.
• Report any unusual bleeding or bruising to your doctor, such as nosebleeds, bleeding gums, heavy menstrual bleeding, urine that looks pink or brown, blood in your stools, or bleeding that will not stop. Also, tell your doctor if you feel dizzy or weak or feel like you may pass out.
• Advise all doctors and dentists that you are taking Xarelto before any invasive or dental procedure is scheduled.
• Xarelto may also increase your risk of bleeding from a minor fall or bump on the head. Contact your doctor if you experience an injury or have bleeding that will not stop. Call 911 if you experience severe or unstoppable bleeding, pink or brown urine, red or black tar-like stools, coughing or vomiting up blood or blood clots (may look like coffee grounds). Also seek urgent medical help with any symptoms of a stroke (such as sudden dizziness, headache or loss of vision; difficulty with speech or slurring of your words, one-sided facial drooping) or signs of a blood clot (sudden, severe shortness of breath; pain, heat or swelling in a limb).
• Always check with your doctor or pharmacist that Xarelto is compatible with other medications (including herbal remedies or products bought over the counter) before taking them.
• Do not stop taking Xarelto suddenly. Your doctor will advise you on how to discontinue Xarelto when or if you no longer require it.