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 Summary of Product Characteristics before prescribing.)

Composition:

Active ingredient: 10 mg rivaroxaban. Excipients1: 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.

For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.

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:

Treatment with rivaroxaban is not recommended in patients: - concomitantly treated systemically with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir), - with severe renal impairment (creatinine clearance <15 ml/min), and due to lack of data: - below 18 years of age, - undergoing hip fracture surgery. The following sub-groups of patients are at increased risk of bleeding and are to be carefully monitored for signs of bleeding complications after initiation of treatment: patients with severe renal impairment (creatinine clearance 15 - 29 ml/min), patients 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) if it is not associated with coagulopathy; patients treated concomitantly with medicinal products affecting haemostasis (such as NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors, other antithrombotic agents) or with the moderate concurrent CYP3A4- and P-gp-inhibitor fluconazole; 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. Strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort) should be used with caution since they may lead to reduced rivaroxaban plasma concentrations and thus may reduce efficacy. Special care is to be taken when neuraxial anaesthesia or spinal/epidural puncture is employed. Xarelto contains lactose.

Undesirable effects:

Common: increased GGT, increase in transaminases (incl. increased ALT, AST), anaemia (incl. respective laboratory parameter), nausea, post-procedural haemorrhage (incl. post-operative anaemia, and wound haemorrhage). Uncommon: increase in: lipase, amylase, blood bilirubin, LDH, alkaline phosphatase, tachycardia, thrombocythaemia (incl. platelet count increased), syncope (incl. loss of consciousness), dizziness, headache, constipation, diarrhoea, abdominal and gastrointestinal pain (incl. upper abdominal pain, stomach discomfort), dyspepsia (incl. epigastric discomfort), dry mouth, vomiting, renal impairment (incl. blood creatinine increased, blood urea increased), pruritus (incl. rare cases of generalised pruritus), rash, urticaria (incl. rare cases of generalised urticaria), contusion, pain in extremity, wound secretion, haemorrhage (incl. haematoma and rare cases of muscle haemorrhage), gastrointestinal tract haemorrhage (incl. gingival bleeding, rectal haemorrhage, haememesis), haematuria (incl. blood urine present), genital tract haemorrhage (incl. menorrhagia), hypotension (incl. blood pressure decreased, procedural hypotension), nose bleed, localised oedema, peripheral oedema, feeling unwell (incl. fatigue, asthenia), fever. Rare: bilirubin conjugated increased (with or without concomitant increased ALT), dermatitis allergic, hepatic function abnormal. Frequency not known: bleeding into a critical organ (e.g. brain), adrenal haemorrhage, conjunctival haemorrhage, haemoptysis, hypersensitivity, jaundice.

Classification for supply:

Medicinal product subject to medical prescription.

Version:

EU/1.1

Marketing Authorisation Holder:

Bayer HealthCare AG, D-51368 Leverkusen, Germany.

Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Efficacy
The ability of a drug to produce the desired effect.