Bilaxten ODT Adverse Reactions

Summary of safety profile in paediatric population: During the clinical development the frequency, type and severity of adverse reactions in adolescents (12 years to 17 years) were the same as observed in adults. The information collected in this population (adolescents) during post-marketing surveillance has confirmed clinical trial findings.
The percentage of children (2-11 years) which reported adverse events (AEs) after treatment with bilastine 10 mg for allergic rhino-conjunctivitis or chronic idiopathic urticaria in a 12-week controlled clinical trial was comparable with patients receiving placebo (68.5% versus 67.5%).
The related AEs most commonly reported by 291 children (2-11 years) receiving bilastine (orodispersible tablet formulation) during clinical trials (#260 children exposed in the clinical safety study, 31 children exposed in the pharmacokinetic study) were headache, allergic conjunctivitis, rhinitis and abdominal pain. These related adverse events occurred with a comparable frequency in 249 patients receiving placebo.
Tabulated summary of adverse reactions in paediatric population: AEs at least possibly related to bilastine and reported in more than 0.1% of children (2-11 years) receiving bilastine during the clinical development are tabulated as follows.
Frequencies are assigned as follows: 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); Rare, very rare and reactions with unknown frequency have not been included in the table. (See Table 1.)

Click on icon to see table/diagram/image

Description of selected adverse reactions in paediatric population: Headache, abdominal pain, allergic conjunctivitis and rhinitis were observed either in children treated with bilastine 10 mg or with placebo. The frequency reported was 2.1% vs. 1.2% for headache; 1.0% vs. 1.2% for abdominal pain; 1.4% vs. 2.0% for allergic conjunctivitis, and 1.0% vs. 1.2% for rhinitis.
Summary of safety profile in adult and adolescent patients: The incidence of adverse events in adult and adolescent patients suffering from allergic rhino-conjunctivitis or chronic idiopathic urticaria treated with 20 mg bilastine in clinical trials was comparable with the incidence in patients receiving placebo (12.7% versus 12.8%).
The phase II and III clinical trials performed during the clinical development included 2525 adult and adolescent patients treated with different doses of bilastine, of which 1697 received bilastine 20 mg. In these trials 1362 patients received placebo. The ADRs most commonly reported by patients receiving 20 mg bilastine for the indication of allergic rhino-conjunctivitis or chronic idiopathic urticaria were headache, somnolence, dizziness, and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
Tabulated summary of adverse reactions in adult and adolescent patients: ADRs at least possibly related to bilastine and reported in more than 0.1% of the patients receiving 20 mg bilastine during the clinical development (N=1697) are tabulated as follows.
Frequencies are assigned as follows: 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); Rare, very rare and reactions with unknown frequency have not been included in the table. (See Table 2.)

Click on icon to see table/diagram/image

Frequency not known (cannot be estimated from the available data): Palpitations, tachycardia, hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, rash, localised oedema/local swelling, and erythema) and vomiting have been observed during the post-marketing period.
Description of selected adverse reactions in adult and adolescent patients: Somnolence, headache, dizziness and fatigue were observed either in patients treated with bilastine 20 mg or with placebo. The frequency reported was 3.06% vs. 2.86% for somnolence; 4.01% vs. 3.38% for headache; 0.83% vs. 0.59% for dizziness, and 0.83% vs. 1.32% for fatigue.
The information collected during the post-marketing surveillance has confirmed the safety profile observed during the clinical development.
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 listed. Patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by visiting the website npra.gov.my [Consumer→ Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)].