Consistent safety profile in the 3-year, real-world evidence study, EMPOWER4
Six (4.3%) TEAEs in 2 (3.8%) patients were determined to be related to TAKHZYRO3
In total, 58 of 112 patients in the safety analysis set reported 154 TEAEs. Of these 154 TEAEs, 6 (in 2 patients) were classified as related to TAKHZYRO3,4
- Fatigue (3), tachycardia (2), and papular rash (1)4
- One new and 1 established patient discontinued TAKHZYRO due to TEAEs related to TAKHZYRO (papular rash and fatigue, respectively)3,4
- Among patients in the overall safety set3,4:
- Infections and infestations were the most frequent (43 events in 34 patients) TEAE Class, followed by
- Gastrointestinal disorders (14 events in 10 patients), and
- General disorders and administration site conditions (11 events in 6 patients)
- There were no reports of injection site reactions related to TAKHZYRO in EMPOWER. Injection site reactions were the most commonly observed adverse reactions in ≥10% of patients in the phase 3 HELP clinical trial3
- TEAEs were mostly mild (66/154) or moderate (79/154) in severity with 7 classified as severe
- Most TEAEs were nonserious (146/154), with 8 considered serious
- Two patient deaths, which were unrelated to TAKHZYRO, occurred during the study (COVID-19 infection [n=1]; traumatic brain injury [n=1])3,4
TEAE=treatment-emergent adverse event.
References: 1. Takhzyro. Prescribing information. Dyax Corp; 2025. 2. Banerji A, Riedl MA, Bernstein JA, et al. JAMA. 2018;320(20):2108-2121. doi:10.1001/jama.2018.16773 3. Data on File. EMPOWER Study. 4. Bernstein JA, Betschel SD, Busse PJ, et al. Adv Ther. 2025;42(8):3882-3901. doi:10.1007/s12325-025-03226-3