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Indication

FIRAZYR® (icatibant injection) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Warnings and precautions: 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.
Please see Important Safety Information below.

OnePath® Assistance Programs

For patients 18 years of age and older with HAE

Access and support through OnePath

OnePath can help patients navigate insurance access and coverage issues.

Dedicated Case Managers will help ensure your patients can understand their coverage for FIRAZYR and offer financial support through a variety of assistance programs.

OnePath Patient Assistance Program

OnePath is committed to helping patients 18 years of age and older get access to FIRAZYR, even those who are uninsured or underinsured. The Patient Assistance Program may help patients access treatment and find insurance that covers their medication.

OnePath Co-Pay Assistance Program*

  • Patients 18 years of age and older with commercial insurance are eligible to receive a OnePath Co-Pay Assistance Card*.
  • This program will help cover the cost of insurance co-pays for FIRAZYR at 100% for eligible patients, up to the program maximum.
  • There are no financial requirements or waiting periods to participate in this program.

*IMPORTANT NOTICE: The OnePath Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), or other federal or state programs (including any state prescription drug assistance programs). 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. The Program cannot be used with any other rebate/coupon, free trial, or similar offer. Co-pay assistance under the Program is not transferable. The Program only applies in the United States and does not apply where prohibited by law, taxed, or restricted. Shire reserves the right to rescind, revoke, or amend the Program at any time without notice. Additional program restrictions may apply.

Getting started on FIRAZYR with OnePath

Download the Start Form for FIRAZYR.

Complete and fax the OnePath Start Form for FIRAZYR to 1-855-ONEPATH
(1-855-663-7284).

Indication

FIRAZYR® (icatibant injection) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

Warnings and precautions

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.

Adverse reactions

The most commonly reported adverse reactions 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, headache, and nausea.

Drug interactions

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.

Use in specific populations

FIRAZYR is classified as pregnancy category C.

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.

Because many drugs are excreted in human milk, caution should be exercised when FIRAZYR is administered to a nursing woman.

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.

Safety and effectiveness in patients below 18 years of age have not been established.

Self-administration

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.

Please see full Prescribing Information.

To report suspected adverse events, please contact Shire, at 1-866-888-0660 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For assistance with medical inquiries about FIRAZYR, please contact Medical Information at 1-866-888-0660 option 2 or .