Xarelto (Rivaroxaban) - patient information, description, dosage and directions.
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.
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.
Preventing dangerous blood clots in the veins in adults who have had total hip or knee replacement surgery.
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.
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.
Liver disorders such as cirrhosis of the liver.
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 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 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).
People with liver disease associated with blood clotting problems and an increased risk of bleeding.
This medicine is not recommended for people with an artificial heart valve.
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.
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.
Collection of blood outside the blood vessels (haematoma).
Weeping or bleeding of the wound after an operation.
Skin reactions such as itching, rash.
Increased numbers of platelets in the blood (thrombocythemia).
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 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.
There are currently no other medicines available in the UK that contain rivaroxaban as the active ingredient.