For your adult patients with hereditary angioedema (HAE)
facing the possibility of unexpected attacks...
Take on what's ahead.
Here you'll learn important information about FIRAZYR, the first prefilled, self-administered, subcutaneous injection to treat acute attacks of HAE in adults 18 years or older.1
FIRAZYR can be used to treat all types of acute HAE attacks: cutaneous, abdominal, and laryngeal.1
See cutaneous and abdominal attack study results »See warnings and precautions, adverse reactions, drug interactions, and other important information you should know about FIRAZYR.
Review safety profile »Patients may self-administer FIRAZYR upon recognition of symptoms of an HAE attack, after training by a healthcare professional.1
Learn more about dosing and administration »Browse through helpful forms, patient education materials, and more.
Browse resources »Enroll your FIRAZYR patients in Takeda Patient Support to help them get answers, resources, and tools.
Learn about Takeda Patient Support »FIRAZYR can be used to treat all types of acute hereditary angioedema (HAE) attacks: cutaneous, abdominal, and laryngeal.1
Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either FIRAZYR 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label FIRAZYR 30 mg. The primary endpoint was assessed using a 100 mm 3-item composite visual analog score (VAS), comprising averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pretreatment composite 3-item VAS score.
In all 3 controlled trials, patients were eligible for treatment of subsequent attacks in an open-label extension.1
FIRAZYR is used to treat attacks of HAE in adults 18 years of age and older.1
A total of 60 patients with laryngeal attacks were treated with FIRAZYR in the controlled trials.1
Please note that given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately, in addition to treatment with FIRAZYR.1
FIRAZYR is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.1
Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately, in addition to treatment with FIRAZYR.1
The safety of FIRAZYR was evaluated in 3 controlled trials that included 223 patients who received FIRAZYR 30 mg (n=113), placebo (n=75) or comparator (n=38).1
The most commonly reported adverse reactions in patients treated with FIRAZYR were injection-site reactions, which occurred in almost all patients (97%) in clinical trials. These injection-site reactions included bruising, hematoma, burning, erythema, hypoesthesia, irritation, numbness, edema, pain, pressure sensation, pruritus, swelling, urticaria, and warmth. Other common adverse reactions included pyrexia (4%), transaminase increase (4%) and dizziness (3%), as well as rash, nausea, and headache.1
The data described below represent adverse reactions observed from the 2 placebo-controlled trials, consisting of 77 patients who received FIRAZYR at a dose of 30 mg SC, and 75 who received placebo.1
aEvents occurring within 14 days of study drug administration.
bInjection-site bruising, hematoma, burning, erythema, hypoesthesia, irritation, numbness, edema, pain, pressure sensation, pruritus, swelling, urticaria, and warmth.
The third trial was active-controlled and comprised 35 patients who received FIRAZYR 30 mg and 38 patients who received the comparator. Adverse reactions for FIRAZYR were similar in nature and frequency to those reported above.1
FIRAZYR is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.1
There are no adequate and well-controlled studies of FIRAZYR in pregnant women. FIRAZYR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.1
Because many drugs are excreted in human milk, caution should be exercised when FIRAZYR is administered to a nursing woman.1
Clinical studies of FIRAZYR included a limited number of subjects aged 65 and over. Elderly patients are likely to have increased systemic exposure. Reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients.1
Safety and effectiveness in patients below 18 years of age have not been established.1
The safety of self-administration was evaluated in a separate, open-label trial in 56 patients with HAE. In this trial, the safety profile of FIRAZYR in patients who self-administered FIRAZYR was similar in nature and frequency to that of patients whose therapy was administered by healthcare professionals.1
Across repeated treatment in the controlled trials, 4 patients tested positive for anti-icatibant antibodies. Three of these patients had subsequent tests, which were negative. No hypersensitivity or anaphylactic reactions were reported with FIRAZYR. No association between anti-icatibant antibodies and efficacy was observed.1
Please see full Prescribing Information.
To report suspected adverse events, please contact Shire at 1-800-828-2088 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
FIRAZYR (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.1
FIRAZYR is the first prefilled, self-administered, subcutaneous injection to treat acute HAE attacks, that is ready to use as soon as patients recognize the symptoms of an attack1
Whether you are considering FIRAZYR for your patients or you are ready to get them started, you will find downloadable resources and forms below that may be helpful to you. FIRAZYR is indicated for the treatment of acute attacks of HAE in adults 18 years of age and older.1
When you prescribe FIRAZYR for your patients, Takeda Patient Support is here for them. Our support specialists provide several services, including:
*To be eligible, your patient must be enrolled in Takeda Patient Support and have commercial insurance. Other terms and conditions apply. Contact us for more details.
Our support specialists are never more than a tap or a call away—1-866-888-0660, Monday through Friday, 8:30 AM to 8:00 PM ET.
Need to enroll your patient? Visit our convenient online enrollment portal at TakedaPatientSupport.com/HCP. You can also enroll your patient by faxing the completed Start Form.
If English is not your patient’s preferred language, we may be able to assist them in a language of their choosing.
The program can cover up to 100% of your patient’s out-of-pocket co-pay costs, if they’re eligible. To be eligible for this program, your patients must:
1. Be prescribed a Takeda treatment for a Food and Drug Administration (FDA) approved indication.
2. Have commercial insurance. This includes Health Insurance Marketplace plans.
3. Be enrolled in Takeda Patient Support.
*IMPORTANT NOTICE: Takeda’s Co-pay Assistance Program ("the Program") provides financial support for commercially insured patients who qualify for the Program. Participation in the Program and provision of financial support is subject to all Program terms and conditions, including but not limited to eligibility requirements, the Program maximum benefit per claim and the annual calendar year Program maximum (“Annual Program Maximum”). The Annual Program Maximum for your prescribed Takeda product can be found by visiting: www.takedapatientsupport.com/copay.
By enrolling in the Program, you agree that the Program is intended solely for the benefit of you—not health plans and/or their partners. Further, you agree to comply with all applicable requirements of your health plan. The Program cannot be used if the patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal, state, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit (FEHB) Program is not a government-funded healthcare program for the purpose of this offer), 2) the Medicare Prescription Drug Program (Part D), or if the patient is currently in the coverage gap, or 3) insurance that is paying the entire cost of the prescription. No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third-party payer, whether public or private.
Some health plans have established programs referred to as ‘co-pay maximizer’ programs. A co-pay maximizer program is one in which the amount of a patient’s out-of-pocket costs is adjusted to reflect the availability of support offered by a manufacturer’s co-pay assistance program. If you are enrolled in a co-pay maximizer program, your Annual Program Maximum may vary over time to ensure the program funds are used for your benefit (for the benefit of the patient). Takeda also reserves the right to reduce or eliminate the co-pay assistance available to patients enrolled in an insurance plan that utilizes a co-pay maximizer program.
If you learn your health plan has implemented a co-pay maximizer program, you agree to notify the Program immediately. It may be possible that you are unaware whether you are subject to a co-pay maximizer program when you enroll or re-enroll in the Program. Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Program at any time if Takeda determines that you are subject to a co-pay maximizer, or similar program.
The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law.
This Program offer is not transferable and is limited to one offer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, co-pay maximizer, alternative funding program, co-pay accumulator, or other offer, including those from third parties and companies that help insurers or health plan manage costs. Not valid if reproduced.
By utilizing the Program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the Program represents that the patient meets the eligibility criteria and other requirements described herein. You must meet the Program eligibility requirements every time you use the Program. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice, and other terms and conditions may apply.