Hexaxim Adverse Reactions

Summary of the safety profile: Data from 5,823 subjects exposed to Hexaxim from completed clinical trials have been used to summarize the safety profile. In clinical studies in individuals who received Hexaxim, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses.
Tabulated list of adverse reactions: The following convention has been used for the classification of adverse reactions: 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 available data). (See Table 4.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Extensive limb swelling: Large injection-site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children. These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th dose.
Pyrexia: When Hexaxim was co-administered with Prevenar 13 (pneumococcal polysaccharide conjugated vaccine, adsorbed) in one clinical trial, data indicated that the percentage of subjects experiencing solicited reactions and unsolicited AEs was similar to the control group given Prevenar 13 and another acellular pertussis-based hexavalent vaccine (Infanrix Hexa). A similar proportion of subjects experienced solicited systemic reactions with the exception of pyrexia (rectal temperature ≥38.0°C), which had a higher incidence for the Hexaxim group (82.3%) than the control group (69.0%). Especially post dose 1, pyrexia was higher in Hexaxim group (46.3%) than the control group (26.3%), which comprises mainly Grade 1 and 2 pyrexia (rectal temperature 38.0 to 39.5°C).
Potential adverse events: (i.e. adverse events that have been reported with other vaccines containing one or more of the components or constituents of Hexaxim and not directly with Hexaxim).
Nervous system disorders: Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine.
Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
Encephalopathy/encephalitis.
Respiratory, thoracic and mediastinal disorders: Apnoea in very premature infants (≤28 weeks of gestation) (see Precautions).
General disorders and administration site conditions: Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines. If this reaction occurs, it is mainly after primary injections and within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events should resolve spontaneously without sequel within 24 hours.
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.