TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.
Rethink dosing and administration
Just 1 subcutaneous self-injection every 2 weeks1
Not an actual patient.
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≤1 MINUTE TO SELF-INJECT for the majority of patients1*
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EVERY 2 WEEKS1
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3 CHOICES FOR INJECTION SITE Abdomen, either thigh, or either arm1
TAKHZYRO requires no reconstitution.1
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
Remind patients to always have acute treatment on hand and periodically check the date to ensure it hasn't expired.
TAKHZYRO is intended for self-administration or administration by a caregiver after being trained by a healthcare professional. Use this video and brochure to help with training.
*In clinical trials, the majority of patients self-administered TAKHZYRO within 10 to 60 seconds.
SELECT IMPORTANT SAFETY INFORMATION
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.
DOSING AND ADMINISTRATION AT A GLANCE
| TAKHZYRO1 | C1-INH PREVENTIVE THERAPIES2,3 | |
|---|---|---|
| Dosing frequency | Once every 2 weeks | Once every 3 or 4 days |
| Volume | 2 mL | 4 to 25 mL† |
| Half-life | ~2 weeks | 56 to 69 hours |
| Manufacturing | Non-plasma derived, recombinant mAb | Derived from human plasma |
| Administration | Subcutaneous injection | Subcutaneous or intravenous injection/infusion |
| How supplied | Ready-to-use single-dose vial | Reconstitution required |
Table does not imply superiority in any respect, and does not include all products in the therapeutic class.
Please see full Prescribing Information for detailed dosage and administration information.
†Based on calculations from approved product Prescribing Information and patient weight assumptions.
Keep patients on track. Even if your patients experience fewer or no attacks during treatment, talk to them about the importance of taking their medication as prescribed to help prevent future attacks.1
SELECT IMPORTANT SAFETY INFORMATION
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.
TAKHZYRO Quick Start Program
Get patients started on TAKHZYRO
Shire will provide eligible patients with immediate access to TAKHZYRO at no cost for a limited time 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.
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. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2010. 3. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017.