Xarelto ( Rivaroxaban )

What is Xarelto?

Xarelto belongs to a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.

Xarelto is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).

This medicine is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation, (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) that is not caused by heart valve disease.

Xarelto is also used to prevent DVT and PE in adults who are having hip replacement or knee replacement surgery or in people who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around or other risk factors.

It is also used along with aspirin to lower the risk of a heart attack, stroke, or death in adults with coronary artery disease (narrowing of the blood vessels that supply blood to the heart) or peripheral arterial disease (poor circulation in the blood vessels that supply blood to the arms and legs).

Xarelto is also used to treat and prevent DVT and PE from happening again in children and certain infants who have received at least 5 days of initial anticoagulation (blood thinner) treatment.

Xarelto is sometimes used to lower your risk of a DVT or PE coming back after you have received treatment for blood clots for at least 6 months.

Xarelto is also used to prevent DVT and PE after heart surgery in children 2 years of age or older who have congenital heart disease (abnormality in the heart that develops before birth).

Warnings

Do not stop taking Xarelto without your doctor’s advice. Stopping it suddenly can increase your risk of blood clots or stroke.

Some drugs can increase your risk of bleeding when used with Xarelto. Tell your doctor about all other medicines you use.

Call your doctor at once if you or your child have signs of bleeding such as: headaches, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, vomit that looks like coffee grounds or any bleeding that will not stop.

Xarelto can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking Xarelto.

You should not use Xarelto if you have an artificial heart valve.

Before taking this medicine

You should not use Xarelto if you are allergic to rivaroxaban or any of the ingredients in Xarelto tablets, or if you have active or uncontrolled bleeding.

Rivaroxaban can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop.

Rivaroxaban can cause a serious blood clot if you undergo a procedure such as a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause permanent or long-term paralysis.

To make sure Xarelto is safe for you, tell your doctor if you have ever had::

• a history of problems with your spine or a spinal surgery;
• a history of difficult or repeated spinal taps;
• a thin tube (catheter) placed in your back to give you certain medicine;
• bleeding problems;
• an artificial heart valve;
• antiphospholipid syndrome, an immune system disorder that increases the risk of blood clots;
• taken NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and other medicines that prevent blood from clotting; or
• liver or kidney disease.

Taking Xarelto during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about the risks.

How should I take Xarelto?

Take Xarelto exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not change your dose or stop taking this medication without your doctor’s advice. Stopping suddenly can increase your risk of blood clots or stroke.

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.

For some conditions, Xarelto should be taken with food. Whether you take the medicine with or without food may also depend on the tablet strength you take. Follow your doctor’s dosing instructions very carefully.

If you cannot swallow a Xarelto tablet whole, crush it and mix the medicine with a small amount of applesauce. Swallow the mixture right away without chewing. If you are taking the 15 mg or 20 mg tablet, the dose should be immediately followed by food.

Follow your healthcare provider’s instructions about giving Xarelto through a feeding tube if needed.

Doses are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.

If your child is taking the tablet, make sure it is swallowed whole. Xarelto should not be split to provide a smaller dose. Talk to your doctor about switching to the oral suspension (liquid).

If your child vomits within 30 minutes of taking the oral suspension (liquid), give a new full dose. If your child vomits more than 30 minutes after taking the oral suspension (liquid), do not give another dose. Give the next dose as scheduled.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Store at room temperature away from moisture and heat. Do not freeze the oral suspension (liquid).

What happens if I miss a dose?

If you take Xarelto 1 time each day: Take the medicine as soon as you remember, and then go back to your regular schedule. Do not take two doses in the same day.

If you take the 15-milligram tablet 2 times each day: Take the missed dose on the same day you remember it. You may take the missed morning dose with the evening dose. Take your next dose at the regular time and stay on your two times a day schedule.

If you take the 2.5-milligram tablet 2 times each day: Skip the missed dose and take your next dose at the regular time. Do not use two doses at one time.

If your child takes Xarelto 2 times each day: give the missed morning dose as soon as you remember. You may give the missed morning dose with the evening dose. If you miss an evening dose, skip the missed dose and then go back to the regular schedule.

If your child takes Xarelto 3 times each day: skip the missed dose and give the next dose at the regular time. Do not give two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

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

An overdose may cause excessive bleeding.

What should I avoid while taking Xarelto?

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Xarelto side effects

Get emergency medical help if you have signs of an allergic reaction to Xarelto: 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, tingling, muscle weakness in your lower body, or loss of bladder or bowel control.

Rivaroxaban can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

• bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual bleeding);
• pain, swelling, new drainage, or excessive bleeding from a wound;
• 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.

Common Xarelto side effects may include:

• bleeding;
• vomiting;
• cough; or
• stomach or gut inflammation.

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.

What other drugs will affect Xarelto?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect rivaroxaban, especially:

• ketoconazole;
• ritonavir;
• erythromycin, rifampin;
• carbamazepine, phenytoin;
• St. John’s wort;
• medicine used to prevent blood clots – enoxaparin, warfarin, alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may interact with rivaroxaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ingredients

Active ingredient: rivaroxaban

Inactive ingredients tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
The proprietary film coating mixture for XARELTO 2.5 mg tablets is Opadry Light Yellow and contains: ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide.
The proprietary film coating mixture for XARELTO 10 mg tablets is Opadry Pink and contains: ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide.
The proprietary film coating mixture for XARELTO 15 mg tablets is Opadry Red and contains: ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide.
The proprietary film coating mixture for XARELTO 20 mg tablets is Opadry II Dark Red and contains: ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

Inactive ingredients for oral suspension: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor, and xanthan gum.

Manufacturer

Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Licensed from: Bayer HealthCare AG 51368 Leverkusen, Germany.