Xarelto

For knee replacement surgery or hip replacement surgery, the usual dose of Xarelto (Rivaroxaban) is 10 mg taken by mouth, once daily with or without food. Xarelto (Rivaroxaban) is generally started within 6 to 10 hours after the surgery. For hip replacement surgery, the treatment should continue for 35 days. For knee replacement surgery, the treatment should continue for 14 days.

To treat blood clots in the veins of the legs or prevent recurrent blood clots in the lungs or veins of your legs, the recommended starting dose is 15 mg taken two times a day, with food, for 3 weeks. After 3 weeks, the recommended dose is 20 mg taken once a day. The treatments should continue until your physician decides otherwise. After 6 months of treatment for blood clots in the lungs or legs, the dose to continue to prevent blood clots from forming again is 10 mg or 20 mg taken once daily. Your doctor will decide on the dose, depending on your risk of experiencing a new blood clot.

For stroke and clot prevention for people with atrial fibrillation, the usual dose is 20 mg taken by mouth, once daily with food.

To prevent stroke, heart attack, risk of sudden death, or clots blocking blood flow to the legs or arms for people with coronary artery disease, or for people with symptomatic peripheral artery disease the usual dose is 2.5 mg taken by mouth twice daily. One of these doses should be taken at the same time as low-dose ASA.

If you are taking 15 mg or 20 mg at a time, it is suggested that you take Xarelto (Rivaroxaban) with or immediately after food. If you cannot swallow tablets whole, Xarelto (Rivaroxaban) may be crushed and mixed with a small amount of applesauce immediately before taking the medication.

For infants and children under the age of 18 years, Xarelto (Rivaroxaban) oral suspension may be used for the treatment of blood clots in the legs or lungs, or to prevent recurrence of clots in the legs or lungs. The dose is based on body weight. Your doctor will calculate the correct dose and the number of times per day it needs to be given. Xarelto (Rivaroxaban) should be given with feeding or with food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Xarelto (Rivaroxaban) exactly as prescribed by your doctor. If you miss a dose of Xarelto (Rivaroxaban) and you are taking the medication once daily, take it as soon as possible and continue with your regular schedule. If you are taking Xarelto (Rivaroxaban) 2.5 mg two times a day, skip the missed dose and continue with your normal schedule. Do not take two doses at once to make up for the missed dose.

If you are taking Xarelto (Rivaroxaban) 15 mg two times a day, take the dose as soon as you remember and continue with your normal schedule. If it is time for your next dose already take 2 tablets (30 mg total) at once, then continue with your normal dosing schedule. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If your child takes Xarelto (Rivaroxaban) suspension twice daily and has missed the morning dose, take the dose as soon as you remember and continue with your normal schedule. If it is already time for the evening dose, you may give the forgotten dose together with the evening dose. A missed evening dose can only be given if you remember on the same evening.

If your child takes Xarelto (Rivaroxaban) suspension three times daily and has missed a dose, skip the missed dose and continue with your regular dosing schedule. Do not take an extra dose to make up for the missed dose.

If you or your child vomits after taking a dose of Xarelto (Rivaroxaban), and it is less than 30 minutes since taking the dose, take another dose. If you or your child vomit and it is more than 30 minutes since you took the dose, do not take another dose. Take your next dose at its regular time.

Store Xarelto (Rivaroxaban) tablets at room temperature and keep them out of the reach of children. Xarelto (Rivaroxaban) suspension may be stored at room temperature or in the refrigerator for 14 days after being prepared. If storing in the refrigerator, allow it to warm to room temperature before administering it to your child.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may reduce your blood clotting ability. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

2.5 mg
Each round, biconvex, film-coated, light yellow, immediate-release tablet of 6 mm diameter, with the Bayer Cross on one side and "2.5" and a triangle on the other side, contains 2.5 mg of Xarelto (Rivaroxaban). Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate; film coating: ferric oxide yellow, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

10 mg
Each round, biconvex, light red, film-coated tablet, marked with the Bayer Cross on one side and "10" and a triangle on the other side, contains Xarelto (Rivaroxaban) 10 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

15 mg
Each round, biconvex, red, film-coated tablet, marked with the Bayer Cross on one side and "15" and a triangle on the other side contains Xarelto (Rivaroxaban) 15 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

20 mg
Each round, biconvex, brown-red, film-coated tablet, marked with the Bayer Cross on one side and "20" and a triangle on the other side contains Xarelto (Rivaroxaban) 20 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.

Granules for Oral Suspension
Following reconstitution, each mL of the oral suspension contains 1 mg of Xarelto (Rivaroxaban). Nonmedicinal ingredients: citric acid, anhydrous, flavour sweet and creamy, hypromellose 5 cp, mannitol, microcrystalline cellulose and carmellose sodium (syn.: microcrystalline cellulose and carboxymethylcellulose sodium), sodium benzoate, sucralose, and xanthan gum.

Supplied as 2.625 g bottle and 5.25 g bottle.

Do not take Xarelto (Rivaroxaban) if you:

• are allergic to Xarelto (Rivaroxaban) or any ingredients of the medication
• are bleeding actively or have a high risk of bleeds
• are pregnant or breast-feeding
• are taking certain medications such as ketoconazole, itraconazole, Voriconazole, posaconazole, or ritonavir
• are taking other anticoagulants (blood thinners, e.g., Warfarin, Heparin, low molecular weight heparin, Apixaban)
• have a body lesion at risk of bleeding, including bleeding in the brain within the last 6 months, or bleeding in your stomach or gut
• have liver disease associated with an increased risk of bleeding

There may be an interaction between Xarelto (Rivaroxaban) and any of the following:

• acetylsalicylic acid (ASA)
• Anagrelide
• other anticoagulant medications (e.g., apixaban, dabigatran, Edoxaban, Fondaparinux, heparin, and low-molecular weight heparins [e.g., Enoxaparin, Dalteparin], warfarin)
• Apalutamide
• "azole" antifungal medications (e.g., ketoconazole, itraconazole, voriconazole)
• Carbamazepine
• Celecoxib
• Clopidogrel
• Cobicistat
• Deferasirox
• Dipyridamole
• Dronedarone
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• garlic
• ginger
• ginkgo biloba
• ginseng
• HIV protease inhibitors (e.g., darunavir, indinavir, ritonavir)
• lumacaftor and Ivacaftor
• macrolides (e.g., erythromycin, clarithromycin)
• medications to break down blood clots (e.g., alteplase, defibrotide, streptokinase, urokinase)
• mifepristone
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Obinutuzumab
• omega-3 fatty acids
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Prasugrel
• primidone
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Dabrafenib, Dasatinib, imatinib, Lapatinib, Sunitinib)
• red clover
• rifampin
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; (e.g., Citalopram, Escitalopram, Fluoxetine, Paroxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• siltuximab
• St. John's wort
• Ticagrelor
• Ticlopidine
• Tocilizumab
• Verapamil
• vitamin E

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xarelto (Rivaroxaban). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

HEALTH CANADA ADVISORY

December 20, 2018

Health Canada has issued new restrictions concerning the use of Xarelto (Xarelto (Rivaroxaban)). To read the full Health Canada Advisory, visit Health Canada's web site at healthycanadians.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xarelto (Rivaroxaban).

Heart valve disease: Xarelto (Rivaroxaban) is not recommended for people who have artificial heart valves or have had artificial aortic valve replacement.

Increased bleeding risk: If you have conditions that are associated with an increased risk of bleeding (e.g., bleeding problems; uncontrolled very high blood pressure; a problem with the blood vessels in the back of the eye called retinopathy; current or past ulcer of the stomach or intestines; recent stroke; or recent surgery of the brain, spinal column, or eye), discuss with your doctor how Xarelto (Rivaroxaban) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xarelto (Rivaroxaban), and whether any special monitoring is needed.

Kidney Disease: Decreased kidney function or kidney disease can cause Xarelto (Rivaroxaban) to build up in the body, causing side effects. If you have kidney disease, discuss with your doctor how Xarelto (Rivaroxaban) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xarelto (Rivaroxaban), and whether any special monitoring is needed.

Lactose: Xarelto (Rivaroxaban) contains lactose. People with certain rare problems associated with lactose or galactose intolerance (e.g., Lapp lactase deficiency, glucose-galactose malabsorption) should not take Xarelto (Rivaroxaban).

Liver disease: If you have liver disease or decreased liver function, discuss with your doctor how Xarelto (Rivaroxaban) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xarelto (Rivaroxaban), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Spinal or epidural injection or catheters: If you have a spinal or epidural catheter, discuss with your doctor how Xarelto (Rivaroxaban) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xarelto (Rivaroxaban), and whether any special monitoring is needed.

Surgery: Inform all health care professionals involved in your care that you are taking Xarelto (Rivaroxaban). Xarelto (Rivaroxaban) may need to be stopped temporarily before dental or surgical procedures to reduce your risk of bleeding heavily during or after the procedure.

Pregnancy: Xarelto (Rivaroxaban) should not be used during pregnancy. If you become pregnant while taking Xarelto (Rivaroxaban), contact your doctor immediately.

Breast-feeding: Xarelto (Rivaroxaban) may pass into breast milk. If you are breast-feeding and are taking Xarelto (Rivaroxaban), it may affect your baby. Xarelto (Rivaroxaban) should not be taken while breast-feeding.

Children: The safety and effectiveness of using Xarelto (Rivaroxaban) for conditions other than the treatment of blood clots in the legs or lungs, or to prevent the recurrence of clots in the legs or lungs have not been established for children less than 18 years of age.

Seniors: The side effects of Xarelto (Rivaroxaban) may be more noticeable in seniors. People who are over 65 years old should discuss with their doctor how Xarelto (Rivaroxaban) may affect them and whether any special monitoring is needed.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food.