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The most common adverse drug reactions reported in adult patients during clinical trials were: back pain (23%), headache (21%), tooth infection (19%), restless legs syndrome (13%), muscle spasms (12%), vitamin D decrease (15%) and dizziness (11%).
(See Precautions and Description of selected adverse reactions as follows.)
Tabulated list of adverse reactions: The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
An overview of adverse reactions observed from clinical trials and post-marketing in paediatric patients is presented in Table 6. (See Table 6.)
Click on icon to see table/diagram/imageAn overview of adverse reactions observed from clinical trials in adults is presented in Table 7. (See Table 7.)
Click on icon to see table/diagram/imageDescription of selected adverse reactions: Injection site reactions: Paediatric patients: Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection. In the paediatric studies, approximately 56% of the patients had an injection site reaction. The injection site reactions were generally mild in severity, occurred within 1 day of medicinal product administration, lasted approximately 1 to 3 days, required no treatment, and resolved in almost all instances.
Adult patients: The frequency of injection site reactions was 12% in both burosumab and placebo treatment groups (injection site reaction, erythema, rash, bruising, pain, pruritis and haematoma). The injection site reactions were generally mild in severity, occurred within 1 day of medicinal product injection, lasted approximately 1 to 3 days, required no treatment, and resolved in almost all instances.
Hypersensitivity: Paediatric patients: Hypersensitivity reactions (including injection site rash, rash, urticaria, swelling face, dermatitis) were reported in 18% of paediatric patients. All reported reactions were mild or moderate in severity.
Adult patients: The incidence of potential hypersensitivity reactions was similar (6%) in the burosumab treated and placebo treated adults. The events were mild to moderate in severity.
Vitamin D Decreased: Paediatric patients: Reduced serum 25 hydroxy-vitamin D has been observed following initiation of burosumab treatment in approximately 8% of paediatric patients, possibly due to increased conversion to activated 1,25 dihydroxy-vitamin D. Supplementation with inactive vitamin D was successful in restoring plasma levels to normal.
Hyperphosphataemia: Adult patients: In the double-blind period of Study UX023-CL303, in the burosumab group during the Placebo-controlled Treatment Period, 9 subjects (13.2%) had high serum phosphate at least once; 5 of these 9 required protocol-specified dose reduction(s). After initiation of burosumab in the open-label Treatment Continuation Period, 8 subjects (12.1%) in the placebo→burosumab group had high serum phosphate levels. Four of these 8 subjects required protocol-specified dose reduction(s). The dose for all patients meeting the protocol-specified criteria was reduced by 50%. A single patient (1%) required a second dose reduction for continued hyperphosphataemia.
Restless legs syndrome: Adult patients: In adults, approximately 12% of the burosumab treatment group and 8% in the placebo group had a worsening of baseline restless legs syndrome or new onset restless legs syndrome of mild to moderate severity.
Immunogenicity: Paediatric and adult patients: Overall, the incidence of anti-drug antibodies (ADA) to burosumab was <10% in adults and paediatric subjects administered burosumab. The incidence of neutralising ADA was 3.2% and neutralising ADA were only found in paediatric subjects. No adverse events, loss of efficacy, or changes in pharmacokinetics profile were associated with these findings.
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 via the national reporting system.
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