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.

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, a real TAKHZYRO® (lanadelumab-flyo) patient, walking.

Sebastian

Real TAKHZYRO patient

HELP Study safety data

Most common ARs (≥10%) observed in the pivotal trial1,6*
TAKHZYRO
every 2 weeks
(n=27)
TAKHZYRO
every 4 weeks
(n=29)
Placebo
(n=41)
Injection site reactions†
56%
45%
34%
Pain
52%
31%
29%
Erythema
7%
7%
2%
Bruising
4%
7%
0%
Upper respiratory infection
44%
31%
32%
Headache§
33%
21%
22%
Rash
4%
10%
5%
Myalgia
11%
0%
0%
Dizziness
4%
10%
0%
Diarrhea
4%
0%
5%

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

Most common ARs (≥10%) observed
in the HELP open-label study5
TAKHZYRO 300 mg every 2 weeks
(N=212)
Injection site pain
47%
Viral upper respiratory tract infection
42%
Upper respiratory tract infection
26%
Headache
25%
Injection site erythema
17%
Arthralgia
13%
Injection site bruising
12%
Back pain
12%
Diarrhea
11%
Sinusitis
11%
Influenza
10%
Nausea
10%
Urinary tract infection
10%

Related, treatment-emergent hypersensitivity reactions.5

Icon of pen.

See efficacy results from the clinical studies

Review Data

Visual representation of TAKHZYRO®, a monoclonal antibody.

TAKHZYRO is plasma-free and inhibits kallikrein activity1

See How It Works

References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Dyax Corp; 2018. 2. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2021. 3. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2020. 4. 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.e2. 5. Banerji A, Bernstein JA, Johnston DT, et al. Long-term prevention of hereditary angioedema attacks with lanadelumab: the HELP OLE Study. Allergy. Published online July 21, 2021. doi:10.1111/all.15011 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:1001/jama.2018.16773