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; pregnancy and lactation.
Warnings and Precautions:
not recommended: in patients concomitantly treated systemically 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), and due to lack of data in patients below 18 years of age or undergoing hip fracture surgery.
Careful monitoring for signs of bleeding required in: patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with moderate renal impairment (creatinine clearance 30 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; cirrhotic patients with moderate hepatic impairment (Child Pugh B) not associated with coagulopathy; patients treated concomitantly with medicinal products affecting haemostasis; patients with congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, active ulcerative gastrointestinal disease, recent gastrointestinal ulcerations, vascular retinopathy, recent intracranial or intracerebral haemorrhage, intraspinal or intracerebral vascular abnormalities, recent brain, spinal or ophthalmological surgery; in patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered.
Use with caution: in patients treated concomitantly with strong CYP3A4 inducers or with fluconazole; when neuraxial anaesthesia or spinal/epidural puncture is employed. Xarelto contains lactose.
Undesirable effects:
Common: post-procedural haemorrhage, nausea, fever, peripheral oedema, increased GGT, increase in transaminases.
Uncommon: anaemia, thrombocythaemia, dizziness, headache, tachycardia, haematoma, gastrointestinal tract haemorrhage, urogenital tract haemorrhage, hypotension, nose bleed, constipation, diarrhoea, abdominal and gastrointestinal pain, dyspepsia, dry mouth, vomiting, pruritus, rash, contusion, pain in extremity, renal impairment, localised oedema, decreased general strength and energy, increase in: lipase, amylase, blood bilirubin, LDH, alkaline phosphatase; wound secretion.
Rare: dermatitis allergic, syncope, hepatic function abnormal, urticaria, feeling unwell, bilirubin conjugated increased.
Frequency not known: hypersensitivity, bleeding into a critical organ, adrenal haemorrhage, conjunctival haemorrhage, haemoptysis, pseudoaneurysm formation following percutaneous intervention, jaundice, compartment syndrome, renal failure/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/4
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; pregnancy and lactation.
Warnings and Precautions:
not recommended: in patients concomitantly treated systemically 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), and due to lack of data in patients below 18 years of age or undergoing hip fracture surgery.
Careful monitoring for signs of bleeding required in: patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with moderate renal impairment (creatinine clearance 30 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; cirrhotic patients with moderate hepatic impairment (Child Pugh B) not associated with coagulopathy; patients treated concomitantly with medicinal products affecting haemostasis; patients with congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, active ulcerative gastrointestinal disease, recent gastrointestinal ulcerations, vascular retinopathy, recent intracranial or intracerebral haemorrhage, intraspinal or intracerebral vascular abnormalities, recent brain, spinal or ophthalmological surgery; in patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered.
Use with caution: in patients treated concomitantly with strong CYP3A4 inducers or with fluconazole; when neuraxial anaesthesia or spinal/epidural puncture is employed. Xarelto contains lactose.
Undesirable effects:
Common: post-procedural haemorrhage, nausea, fever, peripheral oedema, increased GGT, increase in transaminases.
Uncommon: anaemia, thrombocythaemia, dizziness, headache, tachycardia, haematoma, gastrointestinal tract haemorrhage, urogenital tract haemorrhage, hypotension, nose bleed, constipation, diarrhoea, abdominal and gastrointestinal pain, dyspepsia, dry mouth, vomiting, pruritus, rash, contusion, pain in extremity, renal impairment, localised oedema, decreased general strength and energy, increase in: lipase, amylase, blood bilirubin, LDH, alkaline phosphatase; wound secretion.
Rare: dermatitis allergic, syncope, hepatic function abnormal, urticaria, feeling unwell, bilirubin conjugated increased.
Frequency not known: hypersensitivity, bleeding into a critical organ, adrenal haemorrhage, conjunctival haemorrhage, haemoptysis, pseudoaneurysm formation following percutaneous intervention, jaundice, compartment syndrome, renal failure/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/4
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 prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Contraindications:
Hypersensitivity to the active substance or 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); in the treatment of acute pulmonary embolism; in patients below 18 years of age or with prosthetic heart valves or in patients concomitantly treated with dronedarone due to lack of data.
Use with caution: in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly treated with potent CYP3A4 inhibitors; in patients concomitantly treated with medicinal products affecting haemostasis or with strong CYP3A4 inducers; in patients with increased bleeding risk. In patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered. Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period. Specific dose recommendations apply for patients with moderate to severe renal impairment. 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.
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, wound secretion, 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 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/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 prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Contraindications:
Hypersensitivity to the active substance or 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); in the treatment of acute pulmonary embolism; in patients below 18 years of age or with prosthetic heart valves or in patients concomitantly treated with dronedarone due to lack of data.
Use with caution: in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly treated with potent CYP3A4 inhibitors; in patients concomitantly treated with medicinal products affecting haemostasis or with strong CYP3A4 inducers; in patients with increased bleeding risk. In patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered. Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period. Specific dose recommendations apply for patients with moderate to severe renal impairment. 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.
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, wound secretion, 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 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/1
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- Subcutaneous
- Introduced beneath the skin.
- Thrombosis
- Formation of a clot inside a blood vessel.
- 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.
