Lixiana Adverse Reactions

Summary of the safety profile: The safety profile of edoxaban is based on two Phase 3 studies (21,105 patients with NVAF and 8,292 patients with VTE (DVT and PE)), and from post-authorisation experience.
The most commonly reported adverse reactions associated with edoxaban treatment are epistaxis (7.7%), haematuria (6.9%) and anaemia (5.3%).
Bleeding can occur at any site and may be severe and even fatal (see Precautions).
Tabulated list of adverse reactions: Table 12 provides the list of adverse reactions from the two pivotal Phase 3 studies in patients with VTE and NVAF combined for both indications and adverse drug reaction identified in the post-marketing setting. The adverse reactions are classified according to the MedDRA System Organ Class (SOC) and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000). (See Table 12.)

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Description of selected adverse reactions: Haemorrhagic anaemia: Due to the pharmacological mode of action, the use of edoxaban may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia. The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see Overdosage). In the clinical studies mucosal bleedings (e.g. epistaxis, gastrointestinal, genitourinary) and anaemia were seen more frequently during long term edoxaban treatment compared with VKA treatment. Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding, as judged to be appropriate. The risk of bleedings may be increased in certain patient groups e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see Precautions). Menstrual bleeding may be intensified and/or prolonged. Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Known complications secondary to severe bleeding such as compartment syndrome and renal failure due to hypoperfusion have been reported for edoxaban. Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after registration of the pharmaceutical product is important. It allows continued monitoring of the benefit/risk balance of the pharmaceutical product. Healthcare professionals are asked to report any suspected adverse reactions to the registration certificate holder, Daiichi Sankyo Hong Kong Limited.