Xarelto

Uses

What is Xarelto® (rivaroxaban) used for?

Xarelto® is commonly used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery.

Xarelto® is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

Xarelto® may also be used for purposes not listed in this medication guide.

How should I take Xarelto® (rivaroxaban)?

Take Xarelto® exactly as prescribed by your doctor. Xarelto® is taken either once per day or two times per day, depending on the reason you are using this medication. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. Carefully follow your doctor’s dosing instructions.

Tell your doctor if you have trouble swallowing a Xarelto® tablet.

Tell any doctor who treats you that you are using Xarelto®. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using this medicine for a short time.

Use Xarelto® regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

How do I store Xarelto® (rivaroxaban)?

Xarelto® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Xarelto® in the bathroom or the freezer. There may be different brands of Xarelto® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Xarelto® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Xarelto® (rivaroxaban)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Xarelto® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Xarelto® if you have:

• An artificial heart valve
• 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 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.
• 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
• If you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), or clopidogrel (Plavix), or certain antidepressants.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Xarelto® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Xarelto®. Xarelto® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Xarelto® (rivaroxaban)?

Common side effects may include:

• Muscle pain
• Itching
• Pain in your arms or legs

Call your doctor at once if you have:

• Easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding)
• Pain, swelling, or drainage from a wound or where a needle was injected in your skin
• Bleeding from wounds or needle injections
• Any bleeding that will not stop
• Headache, dizziness, weakness, feeling like you might pass out
• Urine that looks red, pink, or brown
• Bloody or tarry stools
• Coughing up blood or vomit that looks like coffee grounds
• A spinal blood clot – back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control

Get emergency medical help if you have any signs of an allergic reaction to Xarelto® hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Xarelto® (rivaroxaban)?

Xarelto® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• Erythromycin
• Rifampin
• St. John’s wort
• Antifungal medication – itraconazole or ketoconazole
• HIV medication – indinavir, lopinavir, ritonavir
• Seizure medication – carbamazepine, phenobarbital, phenytoin

Does food or alcohol interact with Xarelto® (rivaroxaban)?

Xarelto® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Xarelto® (rivaroxaban)?

Xarelto® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Health conditions that may interact with this drug are:

• Kidney disease
• Liver disease

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Xarelto® (rivaroxaban).

What is the dose of Xarelto® (rivaroxaban) for an adult?

Usual Adult Dose 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 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 for Pulmonary Embolism – Recurrent Event:

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

What is the dose of Xarelto® (rivaroxaban) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Xarelto® (rivaroxaban) available?

Xarelto® is available in the following dosage forms and strengths:

• Tablet, film coated: rivaroxaban 10mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Xarelto®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.