TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.
REIMAGINE THE WAY YOU TREAT HAE
For my patients, I want to reimagine:
Not an actual patient.
REDISCOVER PREVENTION
- Significant reduction in mean monthly attacks vs placebo1
- Secondary endpoints of reduction in moderate or severe attacks and attacks requiring acute treatment vs placebo were met1
- There were patients who had zero attacks according to an exploratory analysis1,2
The safety and efficacy of TAKHZYRO was assessed in a 26-week clinical trial of 125 HAE patients ≥12 years of age. The primary efficacy endpoint was the rate of investigator-confirmed attacks during the treatment period compared to placebo. Secondary endpoints included the reduction in moderate or severe attacks and attacks requiring acute treatment. The percentage of patients who had zero attacks over the entire 26-week study duration was a prespecified, exploratory endpoint.
Not an actual patient.
SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
RETHINK DOSING AND ADMINISTRATION
One subcutaneous self-injection every 2 weeks1*
*The recommended starting dose is 300 mg every 2 weeks. TAKHZYRO every 4 weeks is also effective and may be considered if the patient is well-controlled (eg, attack free) for more than 6 months.1
Review dosing andadministration
REFINE THE APPROACH
The first and only monoclonal antibody (mAb) for HAE, TAKHZYRO inhibits plasma kallikrein activity1
SEE HOW TAKHZYRO WORKS
TAKHZYRO Quick Start Program
INTRODUCING THE QUICK START PROGRAM
Shire will provide eligible patients with immediate access to TAKHZYRO at no cost during potential delays in commercial insurance coverage determinations†
†Timing is dependent upon when the forms are received by OnePath®. The Quick Start Program is available to all commercially insured patients ≥12 years of age who are US residents with a confirmed diagnosis of HAE.
Shire and its affiliates reserve the right to change or discontinue this program at any time, without notice. Void where prohibited by law. This program does not constitute a financial assistance program.
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 wholly-owned, indirect subsidiary of Shire plc) at 1–800–828–2088, or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.
Please see full Prescribing Information here.
References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Shire LLC; 2018. 2. Data on file, SHP643-066, Shire Inc.