Ryaltris Adverse Reactions

Adolescents and Adults (12 years of age and older): Clinical Trials: The safety of RYALTRIS in adult and adolescents 12 years of age and older was investigated in 3,062 subjects (36.1% male and 63.9% female) with seasonal allergic rhinitis and 593 subjects (31.7% male and 68.3% female) with perennial allergic rhinitis.
In the placebo- and active-controlled, double-blind randomised clinical studies of 2-week duration in subjects with seasonal allergic rhinitis, the overall incidence of treatment emergent adverse events (TEAEs) was 13.9% in the RYALTRIS treatment group, 13.2% in the olopatadine hydrochloride nasal spray treatment group, 7.9% in the mometasone furoate nasal spray treatment group, and 9.5% in the placebo treatment groups. Overall, <1% of patients in all treatment groups discontinued due to adverse reactions. Table 5 lists treatment-emergent adverse events reported with frequencies ≥1% and more frequently than placebo in patients treated with RYALTRIS in the 2-week SAR studies. (See Table 5.)

Click on icon to see table/diagram/image

The safety data described as follows reflect exposure to RYALTRIS in 789 patients with seasonal allergic rhinitis in clinical studies of 2-week duration. The adverse reactions are listed as follows by system organ class and frequency.
Frequencies are defined as: 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).
Nervous system disorder: Common: dysgeusia (unpleasant taste).
Uncommon: dizziness, headaches, lethargy, somnolence, insomnia.
Respiratory, thoracic and mediastinal disorders: Uncommon: epistaxis, nasal dryness, nasal discomfort, nasal inflammation, oropharyngeal pain, throat irritation, sneezing.
Gastrointestinal disorders: Uncommon: dry mouth, abdominal pain.
General disorders and administration site conditions: Uncommon: Fatigue.
In the double-blind, placebo-controlled, 52-week study (Study GSP 301-303), subjects with perennial allergic rhinitis were randomised to receive RYALTRIS (pH 3.7), a placebo nasal spray pH 3.7, or a placebo nasal spray pH 7.0 administered as 2 sprays/nostril twice daily (morning [AM] and evening [PM]). The safety profile in the long-term perennial allergic rhinitis study was comparable with the 2-week seasonal allergic rhinitis studies. Additionally, improvement in nasal symptoms was observed over the 52-week treatment duration.
Overall, the incidence of treatment-related TEAEs was 51.7% in the RYALTRIS treatment group, 41.4% in the placebo nasal spray pH 3.7 treatment group, and 53.5% in the placebo nasal spray pH 7.0 treatment group. Of the 593 treated patients, 3.8% of patients receiving RYALTRIS discontinued from the study due to an adverse event, compared with 2.0% and 3.0% of patients receiving placebo nasal spray pH 3.7 and pH 7.0, respectively. Table 6 lists TEAEs reported with frequencies ≥1% that were more frequent for RYALTRIS than Placebo pH 3.7. (See Table 6.)

Click on icon to see table/diagram/image

In the RYALTRIS treatment group of the 52-week study, 16 (4.1%) patients experienced mild epistaxis, and 2 (0.5%) patients experienced moderate epistaxis. In the placebo treatment groups, 2 (2.0%) patients in each placebo treatment group experienced mild epistaxis, and no placebo patients experienced moderate epistaxis. No incidents of severe epistaxis were reported in any treatment group. Focused nasal examinations were performed, and no nasal ulcerations were observed.
Paediatrics (6 to 11 years of age): Clinical Trials: The safety of RYALTRIS in children 6 to 11 years of age was investigated in 225 patients (56% male and 44% female) with seasonal allergic rhinitis treated with 1 spray per nostril twice daily.
In the placebo-controlled, double-blind randomised clinical study of 2-week duration, the overall incidence of treatment emergent adverse events (TEAEs) was 12.0% in the RYALTRIS treatment group and 10.4% in the placebo treatment groups. Overall, <2% of patients in all treatment groups discontinued due to adverse reactions. Table 5 lists treatment-emergent adverse events reported with frequencies ≥1% and more frequently than placebo in paediatric patients treated with RYALTRIS in the 2-week SAR study. (See Table 7.)

Click on icon to see table/diagram/image

Reporting suspected adverse effects: Reporting suspected adverse reactions after registration 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 at https://hpvcthai.fda. moph.go.th/reporting-adverse.