CONSISTENT SAFETY PROFILE
The safety profile of TAKHZYRO was established in one of the largest prevention studies in HAE1-5
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
No incidence of anaphylaxis in the pivotal trial.
Injection site reactions were the most common adverse reactions (ARs)1
every 2 weeks
(n=27)
every 4 weeks
(n=29)
(n=41)
*≥10% in any TAKHZYRO group that also occured at a higher rate than placebo group.1
†Additional injection site reactions included hematoma, hemorrhage, pruritis, swelling, induration, paresthesia reaction, warmth, edema, and rash.1
‡Includes upper respiratory infection, viral upper respiratory infection.1
§Includes headache, tension headache, sinus headache.1
∥Includes rash, rash maculopapular, rash erythematous.1
Consistent safety profile seen in 212 patients in the open-label extension study1
Safety data of patients taking TAKHZYRO for an average of 30 months5
Hypersensitivity reactions (2%, n=4) were reported in the study.5*
Six patients discontinued due to treatment-emergent adverse events.5
Three of the subjects discontinued due to hypersensitivity reactions5
One hypersensitivity event was considered related to the study drug and led to discontinuation5
No treatment-related serious adverse events or anaphylaxis were observed.5
(N=212)
Mean study duration: 29.6 (SD=8.2) months.5
*Related, treatment-emergent hypersensitivity reactions.5
Safety profile seen in patients as young as 2 years of age
Safety data of 21 pediatric patients taking TAKHZYRO for 52 weeks1,7
The profile of related TEAEs was similar between the every-2-weeks and every-4-weeks dosing treatment groups.7
No deaths, serious TEAEs, hospitalizations, or discontinuations due to TEAEs were observed.7
No new adverse reactions were identified. Overall, the safety and tolerability were similar between adult patients and pediatric patients (2 to <18 years of age).1
*TEAEs reported by ≥3 patients are presented.7
TEAE=treatment-emergent adverse event.
