Data from FDA - Curated by Marshall Pearce - Last updated 07 December 2017
(6.1) To report SUSPECTED
The data described below represent
The most frequently reported
Because clinical trials are conducted under widely
and Injection site
In all three
Patients were treated with FIRAZYR 30 mg and could receive up to 3 doses of FIRAZYR 30 mg administered at least 6 hours apart for each
A total of 225 patients were treated with 1,076 doses of 30 mg FIRAZYR for 987
In this trial, the
6.2 Immunogenicity Across repeated treatment in the
6.3 Postmarketing Experience Similar
Because these events are reported voluntarily from
2 DOSAGE AND ADMINISTRATION 30 mg injected subcutaneously in the abdominal area.
(2.1) Do not administer more than 3 injections in 24 hours.
(2.1) Patients may self-administer upon
2.2 Administration Instructions FIRAZYR should be inspected visually for particulate matter and
Do not administer if the product contains particulates or is discolored.
Attach the provided
Disinfect the injection site and administer FIRAZYR by subcutaneous injection over at least 30
Patients may self-administer FIRAZYR upon
8 USE IN SPECIFIC POPULATIONS Elderly patients demonstrate
Differences in efficacy and safety between elderly and younger patients have not been identified.
(8.5) 8.1 Pregnancy Pregnancy Category C. There are
Icatibant was not teratogenic in
FIRAZYR should be used during pregnancy only if the potential
Studies in rabbits also indicated that
8.2 Labor and Delivery There are
8.3 Nursing Mothers Because many drugs are excreted in human milk,
Icatibant is excreted into the milk of lactating
8.4 Pediatric Use
Juvenile Toxicity Data Subcutaneous daily administration of icatibant to young
The observed effects may be a consequence of daily icatibant administration.
Toxicity to the testis did not occur in dogs treated twice a week for 9 months [see Carcinogenesis, Mutagenesis,
8.5 Geriatric Use Clinical studies of FIRAZYR did not include
Elderly patients are likely to have
|Date Last Revised||09-12-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||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.|
|Marketing authorisation holder||Shire US Manufacturing Inc.|