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Important Safety Information
Full Prescribing Info

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.

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
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%
2%
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%

*≥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.

IIIncludes rash, rash maculopapular, rash erythematous.

Consistent safety profile seen in 212 patients in a long-term study1

Safety data from an interim analysis of patients taking TAKHZYRO for an average of 20 months5

Hypersensitivity reactions (2%, n=4) were reported in the study.5

6 patients discontinued due to treatment-emergent adverse events.5

No treatment-related serious adverse events or anaphylaxis were observed.5

Most common ARs (≥10%) observed in the HELP open-label study5
TAKHZYRO every 2 weeks
(n=212)
Injection site pain
43%
Viral upper respiratory tract infection
34%
Headache
22%
Upper respiratory tract infection
21%
Injection site erythema
15%
Injection site bruising
11%
Back pain
11%

Related, treatment-emergent hypersensitivity reactions

See efficacy results from the clinical studies

Review Data

TAKHZYRO is plasma-free and inhibits kallikrein activity1

See How It Works

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. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2018. 3. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017. 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. Data on file, TAK743-096, Takeda Pharmaceuticals. 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.