Firazyr will be used for the treatment of documented acute attacks of angioedema induced from angiotensinconverting enzyme ace inhibitors. Diagnostic laboratory testing for hae has been performed including c4 level, c1 inhibitor. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to. Highlights of prescribing information these highlights do. Read all of this leaflet carefully before you start using this medicine because it contains. Allergic angioedema is caused by reaction to foods such as shellfish, nuts, some fruits, medications, insect bites, latex, or other environmental allergens, and results from igemediated mast cell degranulation, with resultant histamine release that causes local tissue swelling. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Firazyr icatibant injection prescribing information.
In the clinical trial, not more than 1 injection of firazyr per hae attack has been administered. Pharmacy prior authorization hereditary angioedema. Sensitization, through prior exposure to the allergen, is usual. It is not known if takhzyro is safe and effective in children under 12 years of age. Firazyr 3 be medically necessary under hawaii law in most cases. Place diluent on a flat surface and insert the blue end of the device into the diluent vial, pushing down. Hereditary angioedema agents independence blue cross. Firazyr icatibant injection for subcutaneous use prior approval criteria. If a treating physician disagrees with hmsacvss determination as to medical necessity in a given case, the physician may request that. Push the plunger, at the top of the syringe, over at least 30 seconds until no firazyr is in the syringe. Always use firazyr exactly as your healthcare professional has shown you. Highlights of prescribing information these highlights do not include all the information needed to use haegarda safely and effectively. Firazyr icatibant is considered medically necessary for the treatment of acute attacks of hereditary angioedema when the following criteria are met. Unitedhealthcare pharmacy clinical pharmacy programs.
Firazyr icatibant injection is a medicine used to treat. Additional criteria for prophylaxis against hereditary angioedema cinryze. Firazyr is prescribed to relieve swelling that occurs during an attack of hereditary angioedema hae. Aeatment cute tr of hereditary angioedema berinert, kalbitor, ruconest, firazyr. Firazyr will be approved based on all of the following criteria. Does the patient have a diagnosis of hereditary angioedema hae type i or type ii as established by c1 inhibitor antigenic levels, c1 inhibitor functional levels and c1q levels. Prior approval is required for some or all procedure codes listed in this corporate drug policy. Program prior authorization firazyr icatibant change control date change 320 new pharmacymedical guideline. These highlights do not include all the information needed to use. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020, wolters kluwer updated. Diagnosis and management of angioedema with abdominal. Product approval information is indicated for treatment of acute abdominal or facial attacks of hereditary angioedema hae in adult and adolescent patients. Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin.
Read all of this leaflet carefully before you start using. And firazyr is prescribed by, or in consultation with, a specialist in. Patients like you are maximizing their time between infusions with hyqvia, a liquid pi treatment given under the skin, once a month. No dosage regimen for children aged less than 2 years or weighing. Firazyr fda prescribing information, side effects and uses. Leave the mix2vial transfer set in the clear package. If you have any further questions, ask your doctor or pharmacist. Firazyr should be inspected visually for particulate matter and discoloration prior to administration. Firazyr 30 mg solution for injection prefilled syringe. Patients who administered firazyr during an acute attack of hae had a median time to 50% reduction from the pretreatment composite 3itemvas score of 2. Generic brand hicl gcn exceptionother icatibant firazyr 35962.
Prior authorization guideline for hereditary angioedema. Firazyr icatibant acetate drug medicine information. Shire orphan therapies application no 22150 approval date. Firazyr icatibant injection hereditary angioedema treatment. Treatment of acute attacks of hereditary angioedema hae.
Patients may selfadminister drug after receiving training from. Be sure to use each firazyr prefilled syringe only once, even if there is still medicine in it. The recommended dosing parameters for the treatment of acute attacks of hereditary angioedema fall within the standard limits. Hyqvia is a oncemonthly subq treatment for pi are you an adult living with primary immunodeficiency pi. Firazyr is indicated for the treatment of acute attacks of hereditary angioedema hae in adults 18. Members age is appropriate for the specific medication requested all age groups for berinert, greater than or equal to 18 years for firazyr, greater than or equal to 12 years for kalbitor and ruconest. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Estimates of annual perpatient expenditures for 150 specialty medications. Selfadministration of intravenous c1inhibitor therapy for hereditary angioedema and associated quality of life benefits. No dose adjustment is required in patients with renal impairment. Selfadministration of firazyr by 56 patients was assessed in an open label trial. Criteria for approval authorization of 12 months may be granted for the treatment of acute hereditary angioedema attacks in members 18 years.
Hereditary angioedema general care and longterm prophylaxis 4 us hereditary angioedema association medical advisory board 20 recommendations for the. Information for the user firazyr 30 mg solution for injection prefilled syringe icatibant read all of this leaflet carefully before you start using this medicine because it contains important information for you. You or your caregiver may inject firazyr only after receiving training on how to use it. Firazyr is indicated for the treatment of acute attacks of hereditary angioedema hae in adults 18 years of age and older. Full prescribing information, including patient information, which is also available. Place the diluent vial on a flat surface and hold the vial tightly. Not used in combination with other approved treatments for acute hae attacks.
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. Dailymed firazyr icatibant acetate injection, solution. Firazyr is cleared nonrenally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. This emedtv page discusses how firazyr is only used after an attack has started, and also offers an explanation on how this drug works. Open the mix2vial transfer set package by peeling away the lid figure 1. Do not use berinert, c1 esterase inhibitor human, if you have experienced lifethreatening allergic reactions or severe hypersensitivity to the product. Takhzyro is a prescription medicine used to prevent attacks of hereditary angioedema hae in people 12 years of age and older. Learn more about associated risks and benefits, including important safety information. Firazyr icatibant is considered medically necessary for the. Consumer medicine information cmi about firazyr icatibant acetate intended for persons living in australia. Firazyr official prescribing information for healthcare professionals.
Restricted access do not disseminate or copy without approval. Firazyr is being requested for the treatment of acute hae attacks 3. For those medications having an indefinite duration of use e. Firazyr icatibant injection is the first fdaapproved injection you give. This patient package insert and instructions for use have been approved by the u.
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