ESTABLISHED SAFETY PROFILE
The safety profile of EOHILIA was well studied in over 400 patients in Study 1 and Study 21
STUDY DESIGNS
The safety of EOHILIA in 410 adults and pediatric subjects 11-56 years of age with EoE was evaluated in two 12-week, double-blind, placebo-controlled studies (Study 1 and Study 2). In these studies, 263 subjects received EOHILIA.1
Most common adverse reactions in Study 11 Reported in at least 2% of patients taking EOHILIA and at a rate greater than in those taking placebo. | |
EOHILIA (n=213) | Placebo (n=105) |
| Respiratory tract infection | |
| 13% | 11% |
| Gastrointestinal mucosal candidiasis | |
| 8% | 2% |
| Headache | |
| 5% | 2% |
| Gastroenteritis | |
| 3% | 1% |
| Sore throat | |
| 3% | 2% |
| Adrenal suppression | |
| 2% | 0% |
| Erosive esophagitis | |
| 2% | 0% |
Definitions:
Respiratory tract infection: includes acute sinusitis, sinusitis, nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection, rhinitis.
Gastrointestinal mucosal candidiasis: includes esophageal candidiasis, oropharyngeal candidiasis, oral candidiasis.
Headache: includes migraine.
Sore throat: includes throat irritation, oropharyngeal pain.
Adrenal suppression: includes adrenal suppression, adrenal insufficiency.
Erosive esophagitis: includes esophagitis only where erosions were present at the esophagogastroduodenoscopy conducted after 12 weeks of treatment.
The safety profile of EOHILIA in Study 2 was generally similar to Study 1.1
Most common adverse reactions in Study 11Reported in at least 2% of patients taking EOHILIA and at a rate greater than in those taking placebo. | ||
Adverse reactions | EOHILIA (n=213) | Placebo (n=105) |
| Respiratory tract infection | 13% | 11% |
| Gastrointestinal mucosal candidiasis | 8% | 2% |
| Headache | 5% | 2% |
| Gastroenteritis | 3% | 1% |
| Sore throat | 3% | 2% |
| Adrenal suppression | 2% | 0% |
| Erosive esophagitis | 2% | 0% |
Definitions:
Respiratory tract infection: includes acute sinusitis, sinusitis, nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection, rhinitis.
Gastrointestinal mucosal candidiasis: includes esophageal candidiasis, oropharyngeal candidiasis, oral candidiasis.
Headache: includes migraine.
Sore throat: includes throat irritation, oropharyngeal pain.
Adrenal suppression: includes adrenal suppression, adrenal insufficiency.
Erosive esophagitis: includes esophagitis only where erosions were present at the esophagogastroduodenoscopy conducted after
12 weeks of treatment.
The safety profile of EOHILIA in Study 2 was generally similar to Study 1.1
WARNINGS AND PRECAUTIONS
The following serious adverse reactions should be monitored in patients taking EOHILIA: hypercorticism and adrenal axis suppression, immunosuppression and increased risk of infections, erosive esophagitis, effect on growth, symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids, other corticosteroid effects, and Kaposi’s sarcoma.1
To report SUSPECTED ADVERSE REACTIONS, call the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see Important Safety Information and full Prescribing Information for additional information.
Reference:
- EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals, Inc.
- Hirano I, Collins MH, Katzka DA, et al. Clin Gastroenterol Hepatol. 2022;20(3):525-534.e10.