Revised SPC: Xarelto (rivaroxaban) 1mg/ml granules for oral suspension and film coated tablets – all strengths

SPC updated to include warning that patients with cancer may be at higher risk of bleeding and thrombosis and the individual benefit should be weighed against risk for bleeding in patients with active cancer dependent on tumour location, antineoplastic therapy & stage of disease.

SPS commentary:

Tumours located in the gastrointestinal or genitourinary tract have been associated with an increased risk of bleeding during rivaroxaban therapy.

In patients with malignant neoplasms at high risk of bleeding, the use of rivaroxaban is contraindicated

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