Rivaroxaban (Xarelto) for preventing stroke in people with atrial fibrillation

Published in Medicine Update

Date published: About this date

Health and medicines information in this article may have changed since the date published. This information does not replace advice from a health professional.

This Medicine Update is for people with atrial fibrillation who are taking, or thinking about taking, rivaroxaban.

Summary

Rivaroxaban is a once-daily tablet that can be used to help prevent strokes in people with a heart condition called atrial fibrillation.

People with atrial fibrillation are more likely to develop a blood clot in their heart. If the blood clot then moves through the blood vessels to the brain it can cause a stroke.

Rivaroxaban reduces the tendency of blood to clot and, therefore, the risk of having a stroke. It belongs to a group of medicines called anticoagulants. Rivaroxaban is an alternative to warfarin, the most commonly used anticoagulant for people with atrial fibrillation.

Rivaroxaban doesn’t treat the irregular rapid heartbeat of atrial fibrillation. Your doctor will prescribe other medicines or treatments for this.

If you are deciding about rivaroxaban, you’ll need to think about the potential harms as well as the possible benefits:

  • As with all anticoagulant medicines, there is a risk of bleeding. Some serious bleeds may be life-threatening, so if you take an anticoagulant you should know how to recognise the signs of bleeding and when to get immediate medical attention.
  • If you do have a serious bleed when taking rivaroxaban, there is currently no specific antidote and it may take longer to treat than if you are taking warfarin.
  • People taking rivaroxaban do not require regular blood tests or dose adjustment as they do with warfarin — there are no blood tests to monitor its effects on blood clotting.
  • Because rivaroxaban is a new medicine, the full range of potential side effects is not yet known.

Tell your pharmacist, dentist, nurse, specialist, and any other health professionals if you are taking rivaroxaban.

Rivaroxaban is currently not subsidised by the PBS when it is prescribed for stroke prevention in atrial fibrillation, but it is available as a private prescription at full cost.

Contents


What rivaroxaban is

The active ingredient of this medicine is rivaroxaban (pronounced riv-ah-ROCKS-ah-ban).

It is also known by the brand name Xarelto.

It is a type of medicine called an anticoagulant. Anticoagulants reduce the tendency of blood to form clots (coagulate).


What rivaroxaban is for

Rivaroxaban is used to help prevent a stroke in people with atrial fibrillation – an irregular, rapid heartbeat that can increase the risk of having a stroke.

How does atrial fibrillation contribute to your risk of stroke?

The irregular heartbeats of atrial fibrillation can lead to blood clots forming in your heart. If one of these blood clots moves from your heart into your bloodstream, it can block a blood vessel to the brain and cause a stroke.

It’s important to note that rivaroxaban doesn’t treat the irregular rapid heartbeat of atrial fibrillation. Your doctor will prescribe other medicines or treatments for this.

Rivaroxaban can also be used:


What does rivaroxaban do?

Like other anticoagulants, rivaroxaban works by decreasing the tendency of your blood to form a clot, or coagulate. This reduces the chance of clots forming and then blocking the blood vessels to your brain.

Anticoagulants are sometimes called blood thinners but they actually work by increasing the time it takes for blood to clot.


Who can take rivaroxaban

You can be prescribed rivaroxaban to prevent a stroke if:

  • you have atrial fibrillation,
    and
  • your atrial fibrillation is not due to heart valve disease or heart valve replacement surgery,
    and
  • your doctor finds that you have one or more of the other risk factors for stroke.

Other factors that can increase your risk of stroke are:

  • heart failure
  • high blood pressure
  • being over 75 years of age
  • diabetes
  • a previous stroke or systemic embolism.

Do not take rivaroxaban if you are at high risk of bleeding because you:

  • have or have recently had a serious bleeding episode (e.g. in the stomach or brain)
  • have severely reduced kidney function
  • have a liver problem that affects blood clotting
  • are taking other medicines that can strongly interact with rivaroxaban (see Check before taking any other medicine).

Do not take rivaroxaban if you are pregnant or breastfeeding.

Rivaroxaban may not be suitable for you if you have another medical condition that increases your likelihood of bleeding. This includes:

  • uncontrolled high blood pressure
  • recent surgery (particularly brain, spine or eye surgery)
  • any bleeding disorder or history of problems with bleeding (e.g. current or recent stomach ulcers).

Your doctor will need to take this into consideration before prescribing rivaroxaban.


How to take rivaroxaban

If you are taking rivaroxaban to prevent stroke, you will need to take one tablet once a day with food.

If you forget to take your rivaroxaban tablet at the usual time, take it as soon as you remember. Do not take more than one tablet in a single day as this will increase your chance of bleeding.

For most people, the usual dose is 20 mg. If you have mild to moderate kidney problems, a lower strength 15 mg tablet is recommended. Your doctor will prescribe the most appropriate dose for you.

Rivaroxaban tablets can be put into dosette boxes or Webster-paks.

How long will I need to take rivaroxaban for?

Rivaroxaban for the prevention of stroke is likely to be a long-term treatment.

You should not stop taking rivaroxaban unless advised by your doctor. Stopping could put you back at risk of developing a blood clot and having a stroke.


Important side effects of rivaroxaban to consider

As with other anticoagulant medicines, the most common side effect of rivaroxaban is bleeding (see Serious bleeding is a risk with all anticoagulants).

Some serious bleeds may be life-threatening.

Ask your health professional about the possible side effects of this medicine before you take it. Always tell them about any changes to your condition if you're taking a new medicine.

To report possible side effects call the NPS Adverse Medicine Events (AME) Line on 1300 134 237.

People with questions about their medicines or seeking general information about side effects can call NPS Medicines Line on 1300 633 424.

Both these services are available Monday to Friday, 9am to 5pm AEST.

Signs and symptoms of bleeding include:

  • unexplained or severe bruising
  • red or dark brown urine
  • red or black bowel motions
  • dark or blood-stained vomit
  • coughing up blood
  • bleeding from cuts, wounds and scrapes that takes longer than normal to stop
  • nosebleeds that occur more frequently or take longer than normal to stop
  • trouble breathing or swallowing
  • severe or unusual headache
  • unexplained tiredness, pale skin, dizziness or fainting
  • unexplained pain, numbness or swelling in an arm or leg.

If you experience any of these signs and symptoms of bleeding, contact your doctor immediately or go to the emergency department at your nearest hospital.

Not all types of bleeding are obvious, especially internal bleeding. Get immediate medical attention if you have a serious fall or injury — particularly if you hit your head — as it may result in internal bleeding that you don’t notice.

As rivaroxaban is a new medicine not all potential side effects are known

Rivaroxaban has been tested in clinical trials, but as it has only been used on a limited number of people for a few years, the full range of potential side effects and who is likely to be affected by them may not yet be known. You should be aware of this and see your doctor straight away if you have any changes in your health or unusual symptoms after starting rivaroxaban.

For a more complete list of possible side effects, see the consumer medicine information (CMI) leaflet for Xarelto (rivaroxaban) through our Medicine Finder.


What else you should know about rivaroxaban

Do not stop taking rivaroxaban without talking to your doctor. Stopping could put you back at risk of developing a blood clot and having a stroke.

Check before taking any other medicine

Because of the high risk of bleeding, rivaroxaban should not be taken with certain other medicines including:

  • itraconazole (Sporanox) and ketoconazole tablets (Nizoral) for fungal infections
  • antiviral medicines used for HIV or AIDS.

Other medicines can also interact with rivaroxaban. You may not need to avoid these entirely, but the doses may need to be changed or you may need to be monitored regularly.

Tell your doctor or pharmacist if you are taking:

  • pain relief or anti-inflammatory medicines, such as:
     – aspirin (e.g. Aspro Clear, Disprin, Solprin)
     – celecoxib (Celebrex)
     – diclofenac (e.g. Fenac, Voltaren)
     – ibuprofen (e.g. Advil, Nurofen)
     – naproxen (e.g. Naprogesic)

Use a medicines list to help keep track of the medicines you are taking. Take it with you each time you visit a health professional, or if you go into hospital.

Get your NPS Medicines List or download the free iPhone app.

  • other medicines used to reduce blood clotting, such as:
     – apixaban (Eliquis)
     – aspirin (e.g. Cartia, Solprin)
     – clopidogrel (e.g. Iscover, Plavix)
     – dabigatran (Pradaxa)
     – dalteparin (Fragmin)
     – enoxaparin (Clexane)
     – fondaparinux (Arixtra)
     – warfarin (Coumadin, Marevan)
  • medicines used to treat epilepsy, such as:
     – carbamazepine (Tegretol)
     – phenytoin (Dilantin)
  • an antibiotic called rifampin or rifampicin (Rifadin)
  • the herbal remedy St John’s wort.

Headache, pain or fever can be treated with paracetamol (e.g. Panadol) as this does not interact with rivaroxaban.

Rivaroxaban does not appear to interact with foods.

Let other health professionals know that you take rivaroxaban

Be sure to tell your pharmacist, dentist, nurse, specialist, and any other health professionals that you’re taking rivaroxaban. They may need to talk to the doctor who prescribed rivaroxaban for you, particularly if you will be having surgery.


Other medicines for preventing stroke caused by atrial fibrillation

Warfarin has been used to prevent stroke for over 50 years. It is very effective, but when you first start taking warfarin, it may take some time to get the dose right.

If you take warfarin, you need to have regular blood tests – called INR tests – to monitor its effect. Your warfarin dose may need to be adjusted based on your results to keep your INR in the target range.

Your INR is affected by many other medicines as well as certain foods. If you are taking warfarin you can still eat most things, but you do need to be careful not to make big changes to how much you eat of certain foods. Read more about INR monitoring.

Dabigatran (Pradaxa) is another newer anticoagulant medicine that can be used for preventing stroke caused by atrial fibrillation. As it is a new medicine, long-term evidence about the risks and benefits is not available. Read more about dabigatran for stroke prevention.

Aspirin is less effective than warfarin or other anticoagulants such as rivaroxaban. It may be an option for some people with atrial fibrillation, but usually only for those at a low risk of stroke or who can’t take warfarin.


How to decide between the different anticoagulant medicines

Ask your doctor to help you weigh up the potential benefits and harms of warfarin and the newer oral anticoagulant medicines – dabigatran (Pradaxa) and rivaroxaban (Xarelto) – based on your individual situation and lifestyle.

When deciding between the different anticoagulant medicines, keep in mind that doctors are familiar with using warfarin and that the benefits and side effects of this established treatment are well known. Rivaroxaban and dabigatran are new medicines, and less is known about their longer-term effects and how to manage any serious bleeding that may occur when taking them.

Dabigatran, rivaroxaban and warfarin are all effective for preventing stroke

In clinical trials, rivaroxaban and dabigatran prevented slightly more strokes overall than warfarin. However, because warfarin is very effective, the improvement with the newer oral anticoagulant medicines was small, and not all groups of people benefitted.

Serious bleeding is a risk with all anticoagulants

In clinical trials comparing dabigatran or rivaroxaban with warfarin, the number of people who had a serious bleed each year was similar – between 3 or 4 out of every 100 people (3% to 4%).

Serious bleeding needs urgent treatment because it may be life-threatening (see Signs and symptoms of bleeding).

For people taking warfarin, vitamin K in a tablet or injection can be given as an antidote to reverse the effect of warfarin if the bleeding won’t stop.

There is currently no specific antidote for rivaroxaban or dabigatran if serious bleeding occurs

This means that if you do have a bleed when you are taking rivaroxaban or dabigatran, it may be more difficult to stop than if you were taking warfarin.

But remember, you should only be prescribed dabigatran, rivaroxaban or warfarin if the benefit is thought to outweigh your risk of serious bleeding.

Some may find the newer oral anticoagulant medicines more convenient

Fewer medicines interact with rivaroxaban or dabigatran than with warfarin. And, unlike warfarin, there are no dietary restrictions with these newer anticoagulant medicines.

As warfarin’s effect can sometimes vary, it’s important to have regular blood tests to make sure that it’s working well. There are no tests to check the effect of rivaroxaban or dabigatran on blood clotting, so people taking these medicines do not need to have regular blood tests.

Some people find these tests inconvenient. But others like the opportunity to discuss their progress with their health professional and check how the warfarin is working.

People managing well on warfarin need not change

In clinical trials, people who took their warfarin regularly and had stable blood test (INR) results appeared to gain no advantage from the newer anticoagulant medicines in terms of a reduced risk of stroke. So, if you are doing well on warfarin therapy, then changing medicines may not be the best option.


Rivaroxaban availability

Rivaroxaban is currently not subsidised through the Pharmaceutical Benefits Scheme (PBS) when it is prescribed for stroke prevention in atrial fibrillation, but it is available for this purpose as a private prescription at full cost.

Some doctors are participating in a Product Familiarisation Program where some of their patients have rivaroxaban provided by the pharmaceutical company.

This Medicine Update is about using rivaroxaban to prevent a stroke in people with atrial fibrillation.

Rivaroxaban is subsidised under the Pharmaceutical Benefits Scheme (PBS) when it is prescribed:

  • after hip or knee replacement surgery to prevent blood clots forming in the legs
  • to treat an existing deep vein thrombosis (DVT), or prevent DVT recurring.
Read more about taking rivaroxaban after hip or knee surgery.

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