Erysaa

Erysaa Adverse Reactions

epoetin alfa

Manufacturer:

Duopharma (M)

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
To determine long term safety, the TEAEs that had occurred in 274 subjects administered at least one dose of PDA10 in the entire study period including the OLE phase were evaluated and the numbers of TEAEs per patient year were analyzed. In addition to this, the numbers of TEAEs per patient year for 146 subjects in the Eprex group during the maintenance phase was also presented as a reference.
The adverse events (AEs) that had occurred in the entire study period were summarized by System Organ Class (SOC) and Preferred Term (PT) and their tabulated summary (≥ 2% of incidence rate by PT) is provided in Table 2 as follows.
The incidence of TEAEs per exposure year was similar between the groups treated with PDA10 and Eprex. Among 274 subjects in the PDA10 group who had received at least one dose of PDA10 in the entire study period including the OLE phase, 169 subjects (61.68% [613 events; 3.22 events per patient year]) had at least one TEAE during the entire study period.
By system organ class (SOC), the most common TEAE in the PDA10 group was 'Infections and infestations' with 119 events reported by 74 subjects (27.01% [0.63 events per patient year]), followed by 'Injury, poisoning and procedural complications' with 68 events reported by 46 subjects (16.79% [0.36 events per patient year]). By PT, the most common TEAE was 'Hypertension' with 71 events reported by 21 subjects (7.66% [0.37 events per patient year]), followed by 'Nasopharyngitis' with 32 events reported by 20 subjects (7.30% [0.17 events per patient year]). Adverse events (AEs) were summarized by System Organ Class (SOC) and Preferred Term (PT) and their tabulated summary is provided in Table 2. (See Table 2.)

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The adverse drug reactions (ADRs), were 10 events reported by 5 subjects (1.69%) including 6 events by 3 subjects (2.00%) in the ERYSAA group and 4 events by 2 subjects (1.37%) in the Eprex group.
By SOC, the most common ADR in the PDA10 group was 'Vascular disorders' with 39 events reported by 3 subjects (1.09% [0.21 events per patient year]), followed by 'Nervous system disorders' with 2 events reported by 2 subjects (0.73% [0.01 events per patient year]) and 'Skin and subcutaneous tissue disorders' with 1 event reported by 1 subject (0.36% [0.01 event per patient year]). By PT, the most common ADR was 'Hypertension' with 37 events reported by 2 subjects (0.73% [0.19 events per patient year]), followed by 'Blood pressure inadequately controlled', 'Hypertensive crisis', 'Cerebral infarction', 'Haemorrhage intracranial' and 'Rash' with 1 event reported by 1 subject each (0.36% [0.01 event per patient year]). The ADRs reported during the entire study are presented by SOC and PT in Table 3. (See Table 3.)

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