Hizentra Adverse Reactions

Summary of the safety profile: In view of the fact that clinical trials are conducted under controlled conditions, adverse drug reaction (ADR) rates observed in the clinical trials of a drug product may not reflect the rates observed in clinical practice.
The Adverse Reactions (ADRs) have been collected in Hizentra clinical trials from 7 Phase III studies with PID (n = 231), 2 phase IV studies in patients with PID (n=74), 1 phase III study (n = 115) and 1 extension study (n=82) in patients with CIDP (total N = 502).
The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC) and Preferred Term Level. The frequencies per patient has been evaluated using the following criteria: 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) and Very rare (≥1/100,000 to <1/10,000). For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown. (See table.)

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Class effects: Infusion site reactions for SCIg.
Pediatric population: Clinical trials with Hizentra showed a similar overall safety profile in pediatric and adult patients with PID.
Hizentra was not evaluated in clinical studies in paediatric patients with CIDP who were under the age of 18.
Geriatric population: Information available from clinical trials showed no difference in safety profile in patients ≥ 65 years of age than in younger patients. Postmarketing experience with Hizentra in patients ≥ 65 years of age shows an overall similar safety profile in this age group as in younger patients.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
For safety with respect to transmissible agents: see Precautions.