Hemapix Adverse Reactions

[Applicable to 2.5 mg - Only]: Summary of the safety profile: The safety of apixaban has been investigated in 7 Phase III clinical studies including more than 21,000 patients: more than 5,000 patients in VTEp studies, more than 11,000 patients in NVAF studies and more than 4,000 patients in the VTE treatment (VTEt) studies, for an average total exposure of 20 days, 1.7 years and 221 days respectively (see Pharmacology: Pharmacodynamics under Actions).
[Applicable to 5 mg - Only]: Summary of the safety profile: The safety of apixaban has been investigated in 4 Phase III clinical studies including more than 15,000 patients: more than 11,000 patients in NVAF studies and more than 4,000 patients in the VTE treatment (VTEt) studies, for an average total exposure of 1.7 years and 221 days respectively (see Pharmacology: Pharmacodynamics under Actions).
[Applicable to 2.5 mg and 5 mg]: Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 13 for adverse reaction profile and frequencies by indication).
[Applicable to 2.5 mg - Only]: In the VTEp studies, in total, 11% of the patients treated with apixaban 2.5 mg twice daily experienced adverse reactions. The overall incidence of adverse reactions related to bleeding with apixaban was 10% in the apixaban vs enoxaparin studies.
[Applicable to 2.5 mg and 5 mg]: In the NVAF studies, the overall incidence of adverse reactions related to bleeding with apixaban was 24.3% in the apixaban vs warfarin study and 9.6% in the apixaban vs acetylsalicylic acid study. In the apixaban vs warfarin study the incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) with apixaban was 0.76%/year. The incidence of ISTH major intraocular bleeding with apixaban was 0.18%/year.
In the VTEt studies, the overall incidence of adverse reactions related to bleeding with apixaban was 15.6% in the apixaban vs enoxaparin/warfarin study and 13.3% in the apixaban vs placebo study (see Pharmacology: Pharmacodynamics under Actions).
[Applicable to 2.5 mg - Only]: Tabulated list of adverse reactions: Table 14 shows the adverse reactions ranked under headings of system organ class 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); not known (cannot be estimated from the available data) for VTEp, NVAF, and VTEt respectively. (See Table 14.)

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[Applicable to 5 mg - Only]: See Table 15.

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[Applicable to 2.5 mg and 5 mg]: The use of apixaban may be associated with an increased risk of occult or overt bleeding from any tissue or organ, which may result in posthaemorrhagic anaemia. The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding (see Precautions and Pharmacology: Pharmacodynamics under Actions).