TAKHZYRO Logo
Budget Impact Analysis
ReferencesLimitations/AssumptionsAbbreviationsUser guide
IntroductionPopulationMarket ShareClinical DataResource Use
& CostsResults
SaveReset

CLINICAL DATA

HAE ATTACKS | ALL ADVERSE EVENTS
Get more information
HAE attacks treated (on-demand treatment)
HAE attacks requiring physician visit1
HAE attacks requiring ER visit1
HAE attacks requiring hospitalization1
Length of hospital stay (days) for HAE attack requiring hospitalization2
Get more information
Baseline HAE attacks per year, adolescents (aged 12-17 years)3
Baseline HAE attacks per year, adults (aged 18-64 years)3
Baseline HAE attacks per year, adults (aged 65 years and over)3

Reduction in HAE attacks from baseline by prophylactic therapy

References: 1. Wilson DA et al. Economic costs associated with acute attacks and long-term management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(4):314-320. 2. Healthcare Cost and Utilization Project. HCUPnet: free health care statistics. 2016. Accessed May 20, 2024. https://datatools.ahrq.gov/ 3. Data on file. HELP study: a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study to evaluate DX-2930 for long-term prophylaxis against acute attacks of hereditary angioedema (HAE). (Clinical study report and patient level data, version 1) 2017. Shire, Inc. 4. Data on file. Indirect treatment comparison of lanadelumab and alternative treatments for prophylaxis in hereditary angioedema. 2018. Shire, Inc. 5. Zuraw BL, Busse PJ, White M, et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010;363(6):513-522. 6. Zuraw B, Lumry WR, Johnston DT, et al. Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: a randomized, double-blind, placebo-controlled phase 3 trial. J Allergy Clin Immunol. 2021;148(1):164-172.

PreviousNext

INDICATION

TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥2 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%) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; dizziness; diarrhea; and myalgia. 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 <2 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.