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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.

DIAGNOSING HAE

Hereditary angioedema (HAE) is a rare genetic disease characterized by recurrent attacks of subcutaneous or submucosal edema that can affect the face, respiratory tract, extremities, gastrointestinal tract, genitalia or other parts of the body.1

Although a general lack of awareness and misunderstanding of symptoms can contribute to delays in diagnosis, once HAE is suspected, diagnostic methods have been established.2,3

Camila, a real TAKHZYRO® (lanadelumab-flyo) patient, sitting with her husband Jorge
Camila
Jorge
Camila
Jorge

Confirming the diagnosis

All patients suspected to have Type I or II HAE should be assessed for blood levels of C1-inhibitor function, C1-inhibitor protein, and C4. If any of the levels are abnormally low, the tests should be repeated to confirm the diagnosis.3

Delays in diagnosis

Historically, delays in diagnosis ranged from 10 to 22 years.4 Today, delays are still common. Although 33% of HAE patients were accurately diagnosed within 1 year of their first HAE attack, there was a delay of more than 10 years in diagnosing 32% of patients.6

Consequences of misdiagnosis

Misdiagnosis can contribute to delays in diagnosis and put patients at an increased risk of ineffective treatments or unnecessary procedures.1,2

Undiagnosed HAE patients are at a higher risk of mortality by asphyxiation following a laryngeal attack.2,6 Laryngeal attacks are rare. However, at least 50% of patients with HAE experience at least 1 laryngeal attack in their lifetime. Mortality of 14% to 33% due to untreated and unrecognized laryngeal attacks has been reported.6

By recognizing and accurately diagnosing patients with HAE, you can help mitigate these risks.

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. Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329–336. 2. Longhurst H, Bork K. Hereditary angioedema: an update on causes, manifestations and treatment. British Journal of Hospital Medicine. July 2019, Vol 80, No7 3. Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema – the 2017 revision and update [published online ahead of print January 10, 2018]. Allergy. doi:10.1111/all.13384. 4. Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008;359(10):1027–1036. 5. Banerji A, Busse P., et al. Current state of hereditary angioedema management: A patient survey. Allergy Asthma Proc. 2015;36:213-217, 2015; doi: 10.2500/aap.2015.36.3824. 6. Bork K., Bernstein J., et al. Efficacy of different medical therapies for the treatment of acute laryngeal attacks of hereditary angioedema due to C1-esterase inhibitor deficiency. The Journal of Emergency Medicine. Doi:10.1016/j.jemermed.2015.11.008