Xarelto®: Summary of Product Characteristics
See the full Xarelto Summary of Product Characteristics (SPC) as approved by the European Commission.
Essential Information
Xarelto 10 mg film-coated tablets.
(Refer to full SmPC before prescribing.)
Composition:
Active ingredient: 10 mg rivaroxaban.
Excipients: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate, macrogol 3350, titanium dioxide (E171), iron oxide red (E172).
Indication:
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients; clinically significant active bleeding; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding.
Warnings and Precautions:
Not recommended: in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors; in patients with severe renal impairment (creatinine clearance <15 ml/min); due to lack of data: in patients below 18 years of age, in patients undergoing hip fracture surgery, in patients concomitantly treated with dronedarone.
Use with caution: in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis or with strong CYP3A4 inducers; in patients with increased bleeding risk; when neuraxial anaesthesia or spinal/epidural puncture is employed. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine, if clinically indicated rivaroxaban levels can be measured by calibrated quantitative anti-Factor Xa tests. Xarelto contains lactose.
Undesirable effects:
Common: anaemia, dizziness, headache, syncope, eye haemorrhage, tachycardia, hypotension, haematoma, epistaxis, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, pain in extremity, urogenital tract haemorrhage, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion.
Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, haemoptysis, dry mouth, hepatic function abnormal, urticaria, cutaneous and subcutaneous haemorrhage, haemarthrosis, renal impairment, feeling unwell, localised oedema. Increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT.
Rare: jaundice, muscle haemorrhage, bilirubin conjugated increased.
Frequency not known: pseudoaneurysm following percutaneous intervention, compartment syndrome or (acute) renal failure secondary to a bleeding.
Classification for supply:
Medicinal product subject to medical prescription.
Marketing Authorisation Holder:
Bayer Pharma AG, D-13342 Berlin, Germany
Further information available from:
medinfo@bayerhealthcare.com
Version:
EU/5
Composition:
Active ingredient: 10 mg rivaroxaban.
Excipients: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate, macrogol 3350, titanium dioxide (E171), iron oxide red (E172).
Indication:
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients; clinically significant active bleeding; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding.
Warnings and Precautions:
Not recommended: in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors; in patients with severe renal impairment (creatinine clearance <15 ml/min); due to lack of data: in patients below 18 years of age, in patients undergoing hip fracture surgery, in patients concomitantly treated with dronedarone.
Use with caution: in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis or with strong CYP3A4 inducers; in patients with increased bleeding risk; when neuraxial anaesthesia or spinal/epidural puncture is employed. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine, if clinically indicated rivaroxaban levels can be measured by calibrated quantitative anti-Factor Xa tests. Xarelto contains lactose.
Undesirable effects:
Common: anaemia, dizziness, headache, syncope, eye haemorrhage, tachycardia, hypotension, haematoma, epistaxis, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, pain in extremity, urogenital tract haemorrhage, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion.
Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, haemoptysis, dry mouth, hepatic function abnormal, urticaria, cutaneous and subcutaneous haemorrhage, haemarthrosis, renal impairment, feeling unwell, localised oedema. Increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT.
Rare: jaundice, muscle haemorrhage, bilirubin conjugated increased.
Frequency not known: pseudoaneurysm following percutaneous intervention, compartment syndrome or (acute) renal failure secondary to a bleeding.
Classification for supply:
Medicinal product subject to medical prescription.
Marketing Authorisation Holder:
Bayer Pharma AG, D-13342 Berlin, Germany
Further information available from:
medinfo@bayerhealthcare.com
Version:
EU/5
Xarelto 15 mg / 20 mg film-coated tablets
(Refer to full SmPC before prescribing.)
Composition:
Active ingredient: 15 mg / 20 mg rivaroxaban.
Excipients: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate, macrogol 3350, titanium dioxide (E171), iron oxide red (E172).
Indication:
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Contraindications:
Hypersensitivity to the active substance or any of the excipients; clinically significant active bleeding; lesion or condition at significant risk of major bleeding; concomitant treatment with any other anticoagulant agent except under the circumstances of switching therapy to or from rivaroxaban or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding.
Warnings and Precautions:
Clinical surveillance in line with anticoagulation practice is recommended throughout treatment. Xarelto should be discontinued if severe haemorrhage occurs. Not recommended: in patients with severe renal impairment (creatinine clearance <15 ml/min); in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors; in patients with increased bleeding risk; due to lack of data: in patients below 18 years of age, in patients with prosthetic heart valves, in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; in patients concomitantly treated with dronedarone. Use with caution: in conditions with increased risk of haemorrhage; in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis or with strong CYP3A4 inducers. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations. Specific dose recommendations apply for patients with moderate to severe renal impairment and, in the case of DVT/PE-patients, only if the patient’s assessed risk of bleeding outweighs the risk for recurrent DVT and PE. Xarelto contains lactose.
Undesirable effects:
Common: anaemia, dizziness, headache, syncope, eye haemorrhage, hypotension, haematoma, epistaxis, haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage, renal impairment, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion.
Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, syncope, tachycardia, dry mouth, hepatic function abnormal, urticaria, haemarthrosis, feeling unwell, localised oedema. increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT.
Rare: jaundice, muscle haemorrhage, localized oedema, bilirubin conjugated increased, vascular pseudoaneurysm (uncommon in prevention therapy in ACS following percutaneous intervention).
Frequency not known: compartment syndrome or (acute) renal failure secondary to a bleeding.
Classification for supply:
Medicinal product subject to medical prescription.
Marketing Authorisation Holder:
Bayer Pharma AG, D-13342 Berlin, Germany
Further information available from:
medinfo@bayerhealthcare.com
Version:
EU/3.1
Composition:
Active ingredient: 15 mg / 20 mg rivaroxaban.
Excipients: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate, macrogol 3350, titanium dioxide (E171), iron oxide red (E172).
Indication:
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Contraindications:
Hypersensitivity to the active substance or any of the excipients; clinically significant active bleeding; lesion or condition at significant risk of major bleeding; concomitant treatment with any other anticoagulant agent except under the circumstances of switching therapy to or from rivaroxaban or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding.
Warnings and Precautions:
Clinical surveillance in line with anticoagulation practice is recommended throughout treatment. Xarelto should be discontinued if severe haemorrhage occurs. Not recommended: in patients with severe renal impairment (creatinine clearance <15 ml/min); in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors; in patients with increased bleeding risk; due to lack of data: in patients below 18 years of age, in patients with prosthetic heart valves, in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; in patients concomitantly treated with dronedarone. Use with caution: in conditions with increased risk of haemorrhage; in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis or with strong CYP3A4 inducers. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations. Specific dose recommendations apply for patients with moderate to severe renal impairment and, in the case of DVT/PE-patients, only if the patient’s assessed risk of bleeding outweighs the risk for recurrent DVT and PE. Xarelto contains lactose.
Undesirable effects:
Common: anaemia, dizziness, headache, syncope, eye haemorrhage, hypotension, haematoma, epistaxis, haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage, renal impairment, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion.
Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, syncope, tachycardia, dry mouth, hepatic function abnormal, urticaria, haemarthrosis, feeling unwell, localised oedema. increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT.
Rare: jaundice, muscle haemorrhage, localized oedema, bilirubin conjugated increased, vascular pseudoaneurysm (uncommon in prevention therapy in ACS following percutaneous intervention).
Frequency not known: compartment syndrome or (acute) renal failure secondary to a bleeding.
Classification for supply:
Medicinal product subject to medical prescription.
Marketing Authorisation Holder:
Bayer Pharma AG, D-13342 Berlin, Germany
Further information available from:
medinfo@bayerhealthcare.com
Version:
EU/3.1
- Subcutaneous
- Introduced beneath the skin.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
