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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 HAE^1-5

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

Real TAKHZYRO patient

HELP Study safety data

Most common ARs (≥10%) observed in the pivotal trial^1,6*

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 study^1,5

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

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 1-877-TAKEDA-7 (1-877-825-3327), 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 1-877-TAKEDA-7 (1-877-825-3327), 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; 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