Highlights of prescribing information these highlights do not include all the information needed to use haegarda safely and effectively. Firazyr fda prescribing information, side effects and uses. Learn more about associated risks and benefits, including important safety information. And firazyr is prescribed by, or in consultation with, a specialist in. No dose adjustment is required in patients with renal impairment. Firazyr official prescribing information for healthcare professionals. Additional criteria for prophylaxis against hereditary angioedema cinryze. Program prior authorization firazyr icatibant change control date change 320 new pharmacymedical guideline. Hyqvia is a oncemonthly subq treatment for pi are you an adult living with primary immunodeficiency pi. 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. Highlights of prescribing information these highlights do. Full prescribing information, including patient information, which is also available. This emedtv page discusses how firazyr is only used after an attack has started, and also offers an explanation on how this drug works. The recommended dosing parameters for the treatment of acute attacks of hereditary angioedema fall within the standard limits.
Firazyr is prescribed to relieve swelling that occurs during an attack of hereditary angioedema hae. Firazyr icatibant injection hereditary angioedema treatment. This patient package insert and instructions for use have been approved by the u. Firazyr should be inspected visually for particulate matter and discoloration prior to administration. Diagnosis and management of angioedema with abdominal. Always use firazyr exactly as your healthcare professional has shown you. Firazyr is indicated for the treatment of acute attacks of hereditary angioedema hae in adults 18. Pharmacy prior authorization hereditary angioedema. Firazyr is cleared nonrenally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. For those medications having an indefinite duration of use e. 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. Firazyr icatibant injection is the first fdaapproved injection you give. Firazyr is indicated for the treatment of acute attacks of hereditary angioedema hae in adults 18 years of age and older.
Firazyr icatibant is considered medically necessary for the treatment of acute attacks of hereditary angioedema when the following criteria are met. No dosage regimen for children aged less than 2 years or weighing. Risk of acute bronchospasm in patients with chronic lung disease acute bronchospasm has been observed in patients with asthma and copd using afrezza. You or your caregiver may inject firazyr only after receiving training on how to use it. Firazyr icatibant is considered medically necessary for the. Currently not fdalabeled or recommended for prophylaxis of hae attacks. Prior authorization guideline for hereditary angioedema. Diagnostic laboratory testing for hae has been performed including c4 level, c1 inhibitor. Place diluent on a flat surface and insert the blue end of the device into the diluent vial, pushing down.
It is not known if takhzyro is safe and effective in children under 12 years of age. Firazyr will be approved based on all of the following criteria. Dailymed firazyr icatibant acetate injection, solution. Hereditary angioedema general care and longterm prophylaxis 4 us hereditary angioedema association medical advisory board 20 recommendations for the. Estimates of annual perpatient expenditures for 150 specialty medications. Firazyr 30 mg solution for injection prefilled syringe. Treatment of acute attacks of hereditary angioedema hae. Selfadministration of firazyr by 56 patients was assessed in an open label trial. 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.
Push the plunger, at the top of the syringe, over at least 30 seconds until no firazyr is in the syringe. Firazyr icatibant injection is a medicine used to treat. Firazyr is being requested for the treatment of acute hae attacks 3. Firazyr icatibant acetate drug medicine information. These highlights do not include all the information needed to use. If a treating physician disagrees with hmsacvss determination as to medical necessity in a given case, the physician may request that. Firazyr icatibant injection for subcutaneous use prior approval criteria. Firazyr icatibant injection prescribing information. Leave the mix2vial transfer set in the clear package. Consumer medicine information cmi about firazyr icatibant acetate intended for persons living in australia. Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Selfadministration of intravenous c1inhibitor therapy for hereditary angioedema and associated quality of life benefits.
Sensitization, through prior exposure to the allergen, is usual. Product approval information is indicated for treatment of acute abdominal or facial attacks of hereditary angioedema hae in adult and adolescent patients. Firazyr icatibant is a bradykinin b2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema hae in adults 18 years of age and older. Criteria for approval authorization of 12 months may be granted for the treatment of acute hereditary angioedema attacks in members 18 years. Not used in combination with other approved treatments for acute hae attacks. Takhzyro is a prescription medicine used to prevent attacks of hereditary angioedema hae in people 12 years of age and older. 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. Read all of this leaflet carefully before you start using. 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.
Read all of this leaflet carefully before you start using this medicine because it contains. Aeatment cute tr of hereditary angioedema berinert, kalbitor, ruconest, firazyr. Firazyr is a bradykinin b2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema hae in adults 18 years of age or older. Patients may selfadminister drug after receiving training from.
Firazyr had hepatorenal syndrome with glomerular filtration rate gfr below 60 mlmin. In the clinical trial, not more than 1 injection of firazyr per hae attack has been administered. Restricted access do not disseminate or copy without approval. Unitedhealthcare pharmacy clinical pharmacy programs. If you have any further questions, ask your doctor or pharmacist. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Shire orphan therapies application no 22150 approval date. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020, wolters kluwer updated. Do not use berinert, c1 esterase inhibitor human, if you have experienced lifethreatening allergic reactions or severe hypersensitivity to the product. Open the mix2vial transfer set package by peeling away the lid figure 1. Place the diluent vial on a flat surface and hold the vial tightly. Be sure to use each firazyr prefilled syringe only once, even if there is still medicine in it. Patients like you are maximizing their time between infusions with hyqvia, a liquid pi treatment given under the skin, once a month.
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