This site is based on the EU Summary of Product Characteristics, and is
intended for healthcare professionals outside of the US, UK, and Ireland.
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.1
The recommended starting dose is TAKHZYRO 300 mg every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of TAKHZYRO 300 mg every 4 weeks may be considered, especially in patients with low weight.1
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics for how to report adverse reactions.
Please see full EU Product Information.
The information on this website is intended for an international healthcare professional audience outside of the United States, United Kingdom, and Ireland only.
HELP STUDY
Double blind, placebo controlled1
of active treatment
(1 month was defined as 28 days
throughout the clinical program)1,15
with HAE Type I or II aged 12 years and older1
HELP OLE
Open-label, long term8
Average treatment
duration was ~30 months8
with HAE Type I or II aged 12 years and older8
*Including C1-INH alone, oral treatment (androgens or antifibrinolytics) alone, or both C1-INH and oral treatment.8,15
†Patients who had 1 to 2 attacks during the run-in period is a calculation (n=60/125).15
‡In HELP OLE, nonrollover patients were required to have a historical attack rate of at least 1 attack within 12 weeks.8
C1-INH=C1 esterase inhibitor; HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.
The recommended starting dose is 300 mg every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg every 4 weeks may be considered, especially in patients with low weight.1
*LTP washout period was only for patients ≥18 years of age.16
†Run-in period could be shortened if patients experienced ≥3 attacks before completion of 4 weeks. If patients experienced no attacks within 4 weeks, the run-in period was extended for another 4 weeks, during which time they needed to have ≥2 attacks to proceed to enrolment and randomisation.24
‡Treatments were administered as 2 separate 1-mL injections in the upper arm every 2 weeks to maintain blinding.15
§The 4-week screening period of the HELP OLE did not include an LTP washout period.23
¶For rollover patients, Day 0 of the HELP OLE coincided with Day 182 (Week 26) of the HELP study. For nonrollover patients, the first dose was administered on Day 0.8
#Regardless of when the first HAE attack occurred, there was a minimum of 10 days between the first and second open-label doses.25
HAE=hereditary angioedema; HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.
All results were with TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
*HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.
Patients taking TAKHZYRO were 7 times more likely to reach MCID than patients taking placebo based on an odds ratio.13
Clinically meaningful improvement is defined as a reduction of ≥6.1
A REDUCTION IN SCORE SHOWS IMPROVEMENT1
All results were with TAKHZYRO 300 mg every 2 weeks.
*These findings are tertiary endpoint analyses and therefore require further investigation to corroborate.
AE-QoL=Angioedema Quality of Life Questionnaire; HELP=Hereditary angioEdema Long-term Prophylaxis; MCID=minimal clinically important difference.