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Important Safety Information
Full Prescribing Info
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TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

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TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

TAKHZYRO Efficacy

TAKHZYRO is clinically proven to help prevent HAE attacks with every-2-weeks dosing that takes ≤1 minute to administer—patients experienced long-term freedom from attacks for an average of 14.8 (SD=12.4) months1,2*†‡

*In clinical studies, the majority of patients self-administered TAKHZYRO within 10 to 60 seconds.1

†Evaluated in a 6.5-month study and a 2.5-year open-label extension (OLE) study.1,2

‡Mean duration of the attack-free period in the OLE study was 14.8 (SD=12.4) months (N=209).2

HELP study

Open-Label Extension Study

One of the largest prevention studies in HAE with the longest active treatment duration1-5

125
Patients1
  • 70% Female6
  • 30% Male6
  • 12 to 73 Years of Age7
6.5
Months
of active treatment
  • (26 weeks)1,6*
56%
previously treated
with long-term
preventive therapy1
  • 48% were on C1-INH alone6
  • 3.2% were on oral therapy6†
  • 4.8% were on both6
52%
HAD ≥3 ATTACKS/‌MONTH DURING RUN-IN PERIOD1

*One month was defined as 28 days in the pivotal trial.6 †Androgens or antifibrinolytics.6

Help Study Design

The pivotal trial was a multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study, which assessed the safety and efficacy of TAKHZYRO in 125 patients with HAE type I or II (≥12 years of age). Patients were randomized to receive TAKHZYRO 150 mg every 4 weeks (n=28), TAKHZYRO 300 mg every 4 weeks (n=29), TAKHZYRO 300 mg every 2 weeks (n=27), or placebo (n=41) for 26 weeks (6.5 months, where 1 month was defined as 28 days). Prior to randomization, patients ≥18 years of age were required to complete a ≥2-week long-term prophylaxis washout period. All patients then entered a 4-week run-in period to determine the baseline HAE attack rate. Patients with ≥1 investigator-confirmed HAE attack during the run-in period were eligible for study enrollment and randomization. The primary efficacy endpoint was the rate of investigator–confirmed attacks during the treatment period (time frame: from Day 0 to Day 182).1,6

Rediscover Effective HAE Prevention

Primary Endpoint

Significant reduction in mean attack rate* vs placebo at 6.5 months in the pivotal trial1,6

87%
REDUCTION
IN ATTACKS
vs placebo (Adjusted P<0.001)1†
  • TAKHZYRO 300 mg every 4 weeks resulted in a 73% reduction in attacks vs placebo (Adjusted P<0.001)1§
  • Mean monthly attack rate at baseline (during the run-in period): 3.52 for TAKHZYRO every 2 weeks (n=27); 3.71 for TAKHZYRO every 4 weeks (n=29); 4.02 for placebo (n=41)6
  • Mean monthly attack rate (during treatment): 0.26 for TAKHZYRO every 2 weeks; 0.53 for TAKHZYRO every 4 weeks; 1.97 for placebo1

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
*Mean monthly attack rate: number of attacks/4 weeks. 1
†Adjusted P-values for multiple testing. 1

SELECT IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

Secondary Endpoints

Significant reduction in different attack severities and attacks requiring acute treatment vs placebo at 6.5 months1,6

Attack reduction vs placebo (Adjusted P<0.001)1,6‡
Reduction in moderate or severe attacks
Reduction in attacks requiring acute treatment
TAKHZYRO 300 mg every 2 weeks (n=27)
83%
87%
TAKHZYRO 300 mg every 4 weeks (n=29)
73%
74%

‡Adjusted P values for multiple testing.

Exploratory Endpoints

Freedom from HAE attacks in the pivotal trial: Many patients taking TAKHZYRO in the study had zero attacks1,6

of patients taking TAKHZYRO (n=27) vs 2% of patients taking placebo (n=41) during the entire 6.5-month study 1,6 REACHED ZERO ATTACKS DAY 0 MONTH 0 DOSE 1 DAY 70 MONTH 2.5 DOSE 6 DAY 182 MONTH 6.5 of patients taking TAKHZYRO (n=26) REACHED ZERO ATTACKS vs 3% of patients taking placebo (n=37) from Day 70 to Day 182 of the study 6
of patients taking TAKHZYRO (n=27) HAD ZERO ATTACKS

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

I knew that I wanted to find a preventive treatment because my HAE attacks were occurring too often, so I did some research, and I found out about TAKHZYRO.
Kelly Real TAKHZYRO patient since 2018

About 97% of patients in the HELP study enrolled in the 2.5-year extension study2

212
Patients2
  • 109 rollover patients, which represents about 97% of patients in the pivotal trial2
  • 103 nonrollover patients2
  • 81.6% of patients completed the study or enrolled in commercial product2
≤2.5
Years
of active treatment2
  • Patients were given TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months2
59%
previously treated
with long-term
preventive therapy2
  • 50% were on C1-INH alone
  • 6.1% were on oral therapy*
  • 3.3% were on both
35%
HAD 1 TO ≤2 ATTACKS/
MONTH at baseline2
  • 39% HAD ≥3 ATTACKS/‌MONTH at baseline2

Long-term safety of TAKHZYRO was the primary endpoint in the open-label extension study.1,2

HELP Open-label Extension Study

The open-label extension study evaluated the safety and efficacy of TAKHZYRO for up to 2.5 years in patients with HAE type 1 or type II (≥12 years of age). It included patients from the pivotal trial (rollover n=109) and additional patients (nonrollover n=103). In the long-term study, 212 patients received TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months. Most patients (81.6%) completed the study or enrolled in commercial product. For rollover patients, the HELP study baseline attack rate (4-week run-in period) was used as this baseline. For nonrollover patients, baseline was defined as the number of investigator-confirmed attacks reported in the last 3 months. Rollover patients, regardless of randomization group in the pivotal trial, received a single dose of TAKHZYRO 300 mg at study entry and were followed until the first HAE attack occurred. After the first HAE attack, all rollover patients received open-label treatment with TAKHZYRO 300 mg every 2 weeks. Nonrollover patients received open-label treatment with TAKHZYRO 300 mg starting on Day 0 and continued to receive TAKHZYRO every 2 weeks throughout the duration of the treatment period. The long-term safety of TAKHZYRO was the primary endpoint in the study.2

*Androgens or antifibrinolytics. SD=standard deviation

The long-term safety of TAKHZYRO was the primary endpoint in this study.2

Effective HAE Prevention in the Long Term

Secondary Endpoints

Patients taking TAKHZYRO for an average of 30 months experienced attack reduction vs baseline2

87%
Reduction
in Attacks
vs baseline (N=209)2
0.25
mean monthly
attack rate
(N=209; baseline: 3.05)2
0.05
median monthly
attack rate
(range: 0.0-4.7; baseline: 2.00)8
  • 84% reduction in moderate or severe attacks (N=209)2
  • 93% reduction in attacks requiring acute treatment (n=106)2

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

SELECT IMPORTANT SAFETY INFORMATION

The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea.

Prespecified Exploratory Endpoints

Freedom from HAE attacks for extended periods of time when taking TAKHZYRO for an average of 30 months2

Zero Attacks for

8 10 out of PATIENTS (81.8%) FOR AT LEAST A 6-MONTH PERIOD (N=209) 2
PATIENTS (81.8%) FOR AT LEAST A 6-MONTH PERIOD (N=209) 2 8 10 out of
% 98 OF DAYS ON AVERAGE DURING TREATMENT PERIOD* (N=209) 2
(N=209) 2 % 98 OF DAYS ON AVERAGE DURING TREATMENT PERIOD*
14.8 WAS THE MEAN DURATION OF THE ATTACK-FREE PERIOD MONTHS (415 days, SD=12.4 months; N=209) 2
14.8 MONTHS WAS THE MEAN DURATION OF THE ATTACK-FREE PERIOD (415 days, SD=12.4 months; N=209) 2

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

*The percentage of days with zero attacks was calculated by counting the number of days in the treatment period without an HAE attack and dividing by the number of days the patient spent in the treatment period.8

Long-term, open-label extension data were consistent with the safety profile and efficacy in the pivotal trial.1,2

Whenever I got an abdominal attack, I would be physically drained. I felt like a battery that was at 0%.
Jenny Real TAKHZYRO patient since 2018
Sebastian, a real TAKHZYRO® patient.

View a real patient case study

Sebastian started TAKHZYRO after learning that his frequent HAE attacks were potentially preventable.

Download CASE STUDY

Explore clinical safety

See safety information established in the pivotal trial and open-label extension study.

See Safety Profile

References: 1. Takhzyro. Prescribing information. Dyax Corp; 2022. 2. Banerji A, Bernstein JA, Johnston DT, et al; HELP OLE Investigators. Long-term prevention of hereditary angioedema attacks with lanadelumab: the HELP OLE study. Allergy. Published online July 21, 2021. doi:10.1111/all.15011 3. Cinryze. Prescribing information. Takeda Pharmaceuticals; 2021. 4. Haegarda. Prescribing information. CSL Behring LLC; 2020. 5. Orladeyo. Prescribing information. BioCryst Pharmaceuticals, Inc; 2020. 6. Banerji A, Riedl MA, Bernstein JA, et al. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121. doi:10.1001/jama.2018.16773 7. Data on file, SHP643-066, Shire Inc. 8. Data on file, TAK743-098, Takeda Pharmaceuticals.