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

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

REIMAGINE the way you treat HAE

TAKHZYRO a first-of-its kind, every-2-week treatment evaluated in one of the largest prevention studies in HAE with the longest active treatment duration.1-5

About TAKHZYRO

Rediscover Prevention

The safety and efficacy of TAKHZYRO were assessed in a 26-week pivotal trial of 125 HAE patients ≥12 years of age. The primary efficacy endpoint was the rate of investigator-confirmed attacks during the treatment period compared to placebo.1,2

Significant reduction in mean attack rate* vs placebo at 6.5 months (26 weeks)1,2

In the Pivotal Trial

87%

REDUCTION IN ATTACKS

(Adjusted P<0.001)1†

  • TAKHZYRO every 4 weeks resulted in a 73% reduction in attacks vs placebo (Adjusted P<0.001)1†
  • Mean monthly attack rate at baseline (during 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)2
  • 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.

The pivotal study 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 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) (Adjusted P<0.001 vs placebo for all; adjusted P values for multiple testing).1,2

*Mean monthly attack rate: number of attacks/4 weeks.

Adjusted P values for multiple testing.

See What's Possible

Rethink dosing and administration

One subcutaneous self-injection every 2-weeks1

The recommended starting dose is 300 mg every 2 weeks. TAKHZYRO every 4 weeks is also effective and may be considered if the patient is well-controlled (eg, attack free) for more than 6 months.

Review dosing and administration

Refine the approach

The first and only monoclonal antibody (mAb) for HAE, TAKHZYRO inhibits plasma kallikrein activity. TAKHZYRO is non-plasma derived.1

See how TAKHZYRO works

TAKHZYRO
Quick Start Program

Get patients started on TAKHZYRO

Get patients started on TAKHZYRO

Takeda will provide eligible patients with immediate access to TAKHZYRO at no cost during potential delays in commercial insurance coverage determinations. Once enrolled, patients will receive assistance from OnePath®, a product support program.

Start your patients right away

Timing is dependent upon when the forms are received by OnePath®. The Quick Start Program is available to all commercially insured patients ≥12 years of age who are US residents with a confirmed diagnosis of HAE. Takeda and its affiliates reserve the right to change or discontinue this program at any time, without notice. Void where prohibited by law. This program does not constitute a financial assistance program.

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Dyax Corp 2018. 2. 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: 1001/jama.2018.16773. 3. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2018.
4. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017. 5. Craig T, Zuraw B, Longhurst H, et al. Long-term outcomes with subcutaneous C1-inhibitor replacement therapy for prevention of hereditary angioedema attacks. J Allergy Clin Immunol Pract. 2019;7(6):1793-1802. 6. Data on file, TAK743-096, Takeda Pharmaceuticals.