Talicia: Well tolerated with a favorable safety profile1
Only 1% of patients (4/305) receiving Talicia discontinued treatment due to an adverse reaction1
| Pivotal Study | Supportive Study | ||||
|---|---|---|---|---|---|
| Adverse Reaction | Talicia (n=228) n (%) | Amoxicillin & Omeprazole (n=227) n (%) | Talicia (n=77) n (%) | Placebo (n=77) n (%) |
|
| Diarrhea | 23 (10.1) | 18 (7.9) | 11 (14.3) | 4 (9.8) | |
| Headache | 17 (7.5) | 16 (7.0) | 12 (15.6) | 4 (9.8) | |
| Nausea | 11 (4.8) | 12 (5.3) | 3 (3.9) | 1 (2.4) | |
| Abdominal Pain | 8 (3.5) | 11 (4.8) | 3 (3.9) | 2 (4.9) | |
| Chromaturia | 0 (0.0) | 0 (0.0) | 10 (13.0) | 1 (2.4) | |
| Rash | 6 (2.6) | 2 (0.9) | 4 (5.2) | 0 (0.0) | |
| Dyspepsia | 5 (2.2) | 3 (1.3) | 1 (1.3) | 0 (0.0) | |
| Vomiting | 5 (2.2) | 5 (2.2) | 1 (1.3) | 2 (4.9) | |
| Oropharyngeal Pain | 2 (0.9) | 2 (0.9) | 3 (3.9) | 0 (0.0) | |
| Vulvovaginal Candidiasis | 5 (2.2) | 5 (2.2) | 0 (0.0) | 0 (0.0) | |
How can a tolerable safety profile help your patients stay on therapy to eradicate H. pylori?
- Adverse reactions leading to discontinuation of Talicia were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each1
- Treatment discontinuation due to an adverse reaction occurred in 1% (4/305) of patients receiving Talicia, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo1
- Chromaturia can occur due to the rifabutin component of Talicia and some of its metabolites. Urine, feces, saliva, sputum, perspiration, tears, and skin may be colored brown-orange during therapy but should resolve after therapy is completed1
- Riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia1
Reference: 1. TALICIA Prescribing Information. RedHill Biopharma Inc.; 2024.