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l attacks
A total of 60 patients with laryngeal attacks were treated with FIRAZYR in the controlled trials. Efficacy results were similar to those observed for non-laryngeal (cutaneous and abdominal) sites of attack.
Self-administration
Self-administration of FIRAZYR by 56 patients was assessed in an open label trial. Patients who administered FIRAZYR during an acute attack of HAE had a median time to 50% reduction from the pretreatment composite 3-itemVAS score of 2.6 hours.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
FIRAZYR is supplied as a single-use, prefilled syringe for subcutaneous administration. Each syringe delivers 3 mL of a sterile solution of icatibant 30 mg (as icatibant acetate). Each glass syringe has a bromobutyl plunger stopper, which is not made of latex natural rubber.
FIRAZYR is available in cartons containing one single-use, prefilled syringe and one 25 G Luer lock needle. NDC 54092-702-02.
FIRAZYR is also available in a pack containing 3 cartons; each carton contains one single-use, prefilled syringe and one 25 G Luer lock needle. NDC 54092-702-03.
16.2 Storage and Handling
Keep out of the reach of children.
Store between 2 - 25° C (36 - 77° F).
Do not freeze.
Store in carton until time of administration.
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
Patients may self-administer FIRAZYR upon recognition of an HAE attack after training under the guidance of a healthcare professional.
Patients with laryngeal symptoms should seek medical attention immediately in an appropriate healthcare facility after administration of FIRAZYR [see Warnings and Precautions (5.1)].
Injection site reactions are reported in most patients after administration of FIRAZYR. Other adverse reactions reported after administration of FIRAZYR include pyrexia, increase in transaminases, dizziness, and rash [see Adverse Reactions (6.1)].
Tiredness, drowsiness, and dizziness have been reported following the use of FIRAZYR. Patients should be advised not to drive or use machinery if they feel tired or dizzy.
Manufactured for:
Shire Orphan Therapies, Inc.
300 Shire Way
Lexington, MA 02421
August 2011
FIRAZYR is protected by U.S. Patent No. 5,648,333
Patient Information
FIRAZYR® (FIR-a-zeer)
(icatibant) Injection
Please read this Patient Information before you use FIRAZYR and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is FIRAZYR?
FIRAZYR is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if FIRAZYR is safe or effective for children under 18 years of age.
What should I tell my healthcare provider before taking FIRAZYR?
Before you use FIRAZYR, tell your healthcare provider if you:
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have any other medical conditions.
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are breastfeeding or plan to breastfeed. It is not known if FIRAZYR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use FIRAZYR.
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are pregnant
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