Xarelto Rivaroxaban

Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and therefore reducing the blood's tendency to form clots.

Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. The Xa factor inhibition disrupts the intrinsic and extrinsic pathways of the coagulation cascade of the blood, inhibiting both thrombin formation and thrombus formation. Rivaroxaban inhibits thrombin (activated factor II) and no effects on platelets have been demonstrated.

Xarelto contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels in the body if you suffer from a form of irregular heart rhythm, called non-valvular atrial fibrillation.
• Treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from reappearing in the blood vessels of the legs and/or from the lungs.

Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist again.

You must take Xarelto with food.

Swallow the tablets, preferably with water.

If you have trouble swallowing the tablet whole, ask your doctor about other ways to take Xarelto. The tablet can be crushed and mixed with water or applesauce immediately before taking it. Then take food.

If necessary, your doctor can also give you the crushed Xarelto tablet through a gastric tube.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels in the body

The recommended dose is one Xarelto 20 mg tablet once a day.

If you have kidney problems, the dose can be decreased to one Xarelto 15 mg tablet once a day.

If you need to have a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with a stent insertion), there is limited evidence of reducing the dose to one Xarelto 15 mg tablet once daily ( or one Xarelto 10 mg tablet once a day if your kidneys are not working properly) in addition to an antiplatelet medication such as clopidogrel.

To treat blood clots in the leg veins and in the blood vessels of the lungs, and to prevent blood clots from recurring.

The recommended dose is one Xarelto 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Xarelto 20 mg tablet once a day.

After at least 6 months of blood clot treatment, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day.

If you have kidney problems and take one Xarelto 20 mg tablet once a day, your doctor may decide to reduce the treatment dose to one Xarelto 15 mg tablet once a day after 3 weeks if the risk of bleeding is greater than the risk of having another blood clot.

When to take Xarelto.

Take the tablets every day until your doctor tells you to. Try to take the tablets at the same time each day to remember what time you should take them. The doctor will decide how long you should continue taking the treatment.

To prevent blood clots from forming in the brain (stroke) or other blood vessels: If it is necessary to normalize the heartbeat through a procedure called cardioversion, take Xarelto at the times your doctor has prescribed.

Like all medicines, Xarelto can cause side effects, although not everybody gets them.

Like other similar medications (antithrombotics), Xarelto can cause bleeding that can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Possible side effects that may be signs of bleeding

Tell your doctor immediately if you experience any of the following symptoms:

prolonged or excessive bleeding

exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may be signs of bleeding.

Your doctor may decide to keep you under closer observation or change your treatment.

Possible side effects that may be signs of a severe skin reaction. Tell your doctor immediately if you experience skin reactions such as:

Intense spreading skin rashes, blisters, or lesions on the mucosa, eg, in the mouth or eyes (Stevens-Johnson syndrome / toxic epidermal necrolysis). The frequency of this adverse effect is very rare (up to 1 in 10,000).

Reaction to medications that cause a rash, fever, inflammation of the internal organs, hematological abnormalities, and systemic disease (DRESS syndrome). The frequency of this adverse effect is very rare (up to 1 in 10,000).

Possible side effects that may be signs of a severe allergic reaction

Tell your doctor immediately if you experience any of the following side effects:

• Swelling of the face, lips, mouth, tongue or throat; difficulty to swallow; hives and difficulty breathing; a sudden drop in blood pressure. The frequencies of these side effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and infrequent (angioedema and allergic edema; may affect up to 1 in 100 people).

Common side effects (may affect up to 1 in 10 people)

• decreased red blood cells which can cause paleness and weakness or difficulty breathing
• bleeding from the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a body tissue or cavity (bruise, bruises)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after an operation
• oozing of blood or fluid from a surgical wound
• swelling of the extremities
• limb pain
• impaired kidney function (may be seen in tests done by the doctor)
• fever
• stomach pain, indigestion, dizziness or lightheadedness, constipation, diarrhea
• low blood pressure (symptoms may be dizzy or lightheaded when standing up)
• general decrease in strength and energy (weakness, tiredness), headache, dizziness,
• rash, itchy skin
• blood tests may show an increase in some liver enzymes

Uncommon side effects (may affect up to 1 in 100 patients)

• bleeding in the brain or inside the skull
• bleeding in a joint, causing pain and swelling
• thrombocytopenia (low number of platelets, cells that help blood to clot)
• allergic reaction, including allergic skin reaction
• disturbance of liver function (can be seen in tests carried out by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or the number of platelets
• An increase in cardiac frequency
• dry mouth
• hives

Rare side effects (may affect up to 1 in 1,000 patients)

• bleeding in a muscle
• cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• Accumulation of blood (hematoma) in the groin after a complication of cardiac surgery in which a catheter is inserted into the artery of the leg (pseudoaneurysm)

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