Safety Profile
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.1
No incidence of anaphylaxis in the pivotal trial.1
Injection site reactions were the most common adverse reactions (ARs).1
Sebastian
Real TAKHZYRO patientHELP Study safety data
every 2 weeks
(n=27)
every 4 weeks
(n=29)
(n=41)
All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
*≥10% in any TAKHZYRO group that also occurred at a higher rate than placebo group.
†Additional injection site reactions included hematoma, hemorrhage, pruritus, swelling, induration, paresthesia, reaction, warmth, edema, and rash.
‡Includes upper respiratory infection, viral upper respiratory infection.
§Includes headache, tension headache, sinus headache.
∥Includes rash, rash maculopapular, rash erythematous.
Consistent safety profile seen in 212 patients in the open-label extension study1,5
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 the hypersensitivity reactions5
- One hypersensitivity event was considered related to study drug and led to discontinuation5
No treatment-related serious adverse events or anaphylaxis were observed.5
in the HELP open-label study5
(N=212)
¶Related, treatment-emergent hypersensitivity reactions.5
See efficacy results from the clinical studies
