Xarelto (Rivaroxaban)

How does it work?

Xarelto tablets contain the active ingredient rivaroxaban, which is a type of medicine called an anti-thrombotic. It is used to stop blood clots forming within the blood vessels.

Blood clots usually only form to stop bleeding that has occurred as a result of injury to tissue in the body. The blood clotting process is complicated. When blood begins to clot, a cascade of chemicals is activated within the body, resulting in the formation of an enzyme called thrombin.

Thrombin is central to the complete process of blood clotting. It causes a protein called fibrinogen to be converted into another called fibrin. Fibrin binds blood cells called platelets together, and this forms the blood clot. This is the body’s natural way of repairing itself.

Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus and can be dangerous because the clot may detach and travel in the bloodstream. The clot may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism.

Some people have an increased tendency for blood clots to form within the blood vessels. This is usually due to a disturbance in the blood flow within the blood vessels. For example, fatty deposits on the walls of the blood vessels (atherosclerosis) can disrupt the blood flow, giving a tendency for platelets to clump together and start off the clotting process.

After hip or knee replacement surgery there is also a risk of blood clots forming in the blood vessels. This risk is increased by being immobile for long periods of time following the surgery, as a result of slowed blood flow in the leg and pelvic veins. A clot that forms in the veins of the leg is called a deep vein thrombosis. These dangerous blood clots can travel to the lungs, causing a serious condition called a pulmonary embolism.

People with a type of fast irregular heartbeat called atrial fibrillation (AF) are also at risk of blood clots forming, both within the heart and in the blood vessels. This is because the abnormal heart rhythm disrupts blood flow in the blood vessels. Clots in the heart can detach and travel to the brain, causing a stroke. Clots can also travel in and block other blood vessels around the body.

Rivaroxaban is used to prevent and treat these types of blood clots. It works by binding to a substance called factor Xa, which prevents the formation of thrombin. This stops the formation of fibrin, the essential component of blood clots.

What is it used for?

  • Preventing dangerous blood clots in the veins in adults who have had total hip or knee replacement surgery.
  • Treating blood clots in the veins of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
  • Preventing recurrent deep vein thrombosis and pulmonary embolism.
  • Preventing the formation of blood clots that can cause a stroke or blockage of other blood vessels in the body in people with a type of irregular heartbeat called atrial fibrillation (AF). This medicine is licensed to prevent blood clots in people with AF who have one or more of the following additional risk factors:
    • age over 75 years
    • a history of stroke or mini stroke (TIA)
    • heart failure
    • high blood pressure
    • diabetes.

How do I take it?

  • Xarelto tablets should be taken with food. They should be swallowed with a drink of water.
  • The dose prescribed and how often the medicine needs to be taken depends on the reason for taking the medicine. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
  • If this medicine is being used to prevent blood clots following hip or knee replacement surgery, treatment should be started six to ten hours after the surgery, though this may be delayed if there are any complications with bleeding after surgery.
  • The tablets are usually taken once daily for 14 days following a knee replacement and for 35 days following a hip replacement.
  • For treating a DVT or pulmonary embolism, the tablets are usually taken twice a day for three weeks. After this the dose is reduced to once a day for as long as your doctor considers necessary. This will depend on the cause of the initial blood clot and how likely you are to get another.
  • For preventing blood clots in people with AF the tablets are usually taken once daily on a long-term basis.
  • Do not stop taking this medicine until you have been advised to by your doctor.

Warning!

  • This medicine may make you feel dizzy or faint. You should not drive or operate machinary until you know how this medicine affects you and are sure you can do so safely.
  • As this medicine prevents blood clotting, the most common side effects associated with treatment involve bruising or bleeding. Not all people will experience side effects. However, you should let your doctor know straight away if you notice any sign of bruising or bleeding while you are taking this medicine. This includes nosebleeds or bleeding from the gums, as well as any signs of blood in your urine, or any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.
  • It is important that you tell any health professional treating you, including your dentist, that you are taking this medicine. If you are due to have any surgery it is also important to talk to your doctor in advance about your medicine. Your doctor may want you to stop taking your Xarelto for 24 hours before the surgery. Follow the instructions given by your doctor.

Use with caution in

  • Moderate to severely decreased kidney function.
  • Liver disorders such as cirrhosis of the liver.
  • People with an increased tendency to bleed, for example due to blood clotting disorders such as haemophilia, or the conditions listed below.
  • People with low numbers of blood cells called platelets in their blood (thrombocytopenia).
  • People with active or recent ulcerative diseases of the intestines, eg peptic ulcers or ulcerative colitis.
  • People with uncontrolled very high blood pressure (hypertension).
  • People who have recently had brain, spinal or eye surgery.
  • People who have recently had bleeding inside the skull or brain (intracranial or intracerebral haemorrhage).
  • People who have a problem with the blood vessels at the back of the eye (vascular retinopathy).
  • People with abnormalities of the blood vessels in the brain or spinal cord.
  • People who are coughing up blood or who have a history of bleeding in the lungs.
  • People having spinal or epidural anaesthesia or injection into the spine.
  • People who have an indwelling catheter in their spine for pain relief after surgery.
  • People taking medicines that may increase the risk of bleeding, for example anticoagulants such as warfarin, antiplatelets such as aspirin or clopidogrel, or non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac or ibuprofen (see end of factsheet for more examples).

Not to be used in

  • People with active severe or dangerous bleeding.
  • People with liver disease associated with blood clotting problems and an increased risk of bleeding.
  • Pregnancy.
  • Breastfeeding.
  • This medicine is not recommended for people having surgery for a hip fracture.
  • This medicine is not recommended for people with an artificial heart valve.
  • This medicine is not recommended for children and adolescents less than 18 years of age, as its safety and efficacy have not been established in this age group.
  • Xarelto tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine during pregnancy has not been established. The manufacturer states that this medicine should not be used during pregnancy because of the risk of bleeding and potential risk of harm to a developing baby.
  • Women who could get pregnant should use an effective contraception method while taking this medicine to avoid getting pregnant. Seek medical advice from your doctor.
  • It is not known if rivaroxaban passes into breast milk. This medicine should therefore not be used during breastfeeding. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

  • Dizziness.
  • Fainting.
  • Headache.
  • Nosebleeds (epistaxis).
  • Bruising.
  • Collection of blood outside the blood vessels (haematoma).
  • Weeping or bleeding of the wound after an operation.
  • Bleeding in the eyes.
  • Bleeding gums.
  • Heavy menstrual periods.
  • Blood in the urine.
  • Bleeding from the rectum.
  • Bleeding in the gut.
  • Anaemia.
  • Disturbances of the gut, such as constipation, diarrhoea, abdominal pain, indigestion, feeling sick or vomiting.
  • Skin reactions such as itching, rash.
  • Increased heart rate (tachycardia).
  • Low blood pressure.
  • Feeling weak or fatigued.
  • Fever.
  • Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Dry mouth.
  • Generally feeling unwell.
  • Coughing up blood.
  • Bleeding in a joint.
  • Bleeding inside the skull.
  • Bleeding under the skin.
  • Abnormal liver function.
  • Decreased kidney function.
  • Jaundice.
  • Nettle-type rash (urticaria).
  • Excessive fluid retention in the body tissues, resulting in swelling (oedema).
  • Increased numbers of platelets in the blood (thrombocythemia).
  • Allergic dermatitis.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

  • Bleeding in a muscle.

Unknown frequency

  • Kidney failure.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The medicines listed below increase the blood level of rivaroxaban, which could increase the risk of bleeding. Rivaroxaban is not recommended for people taking these medicines:

  • antifungal medicines such as ketoconazole, itraconazole, posaconazole and voriconazole (fluconazole has less of an effect and can be used with caution).
  • HIV protease inhibitors such as atazanavir, nelfinavir, ritonavir, saquinavir and indinavir.

The antibiotics clarithromycin and telithromycin may increase the blood level of rivaroxaban in people with kidney problems, which could increase the risk of bleeding. These medicines should be used with caution in people with kidney problems who are taking Xarelto.

There may also be an increased risk of bleeding if any of the following medicines that are used to prevent blood clotting are used in combination with rivaroxaban:

  • acenocoumarol
  • aspirin
  • bivalirudin
  • clopidogrel
  • dabigatran
  • danaparoid
  • dipyridamole
  • fondaparinux
  • heparins or low-molecular weight heparins
  • lepirudin
  • phenindione
  • thrombolytic agents (clot-busters), eg alteplase, streptokinase
  • glycoprotein IIb/IIIa receptor antagonists, eg abciximab, eptifibatide and tirofiban
  • warfarin.

There may be an increased risk of bleeding if non-steroidal anti-inflammatory drugs used to relieve pain and inflammation (NSAIDs, eg diclofenac, ibuprofen, naproxen) are taken in combination with this medicine. You should only take this type of painkiller on the advice of your doctor.

The following medicines may reduce the amount of rivaroxaban in the blood, which could make it less effective at preventing blood clots:

  • carbamazepine
  • phenytoin
  • rifampicin
  • the herbal remedy St.John’s wort (Hypericum perforatum).

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain rivaroxaban as the active ingredient.