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KALBITOR
(ecallantide) Injection, for Subcutaneous Use
WARNING
Anaphylaxis
Anaphylaxis has been reported after administration of KALBITOR (ecallantide injection) . Because of the risk of anaphylaxis, KALBITOR (ecallantide injection) should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR (ecallantide injection) to patients with known clinical hypersensitivity t o KALBITOR. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS]
KALBITOR (ecallantide) is a human plasma kallikrein inhibitor for injection for subcutaneous use.
KALBITOR (ecallantide injection) is a clear and colorless, sterile, and nonpyrogenic solution. Each vial contains 10 mg ecallantide as the active ingredient, and the following inactive ingredients: 0.76 mg disodium hydrogen orthophosphate (dihydrate), 0.2 mg monopotassium phosphate, 0.2 mg potassium chloride, and 8 mg sodium chloride in water for injection, USP. KALBITOR (ecallantide injection) is preservative free, with a pH of approximately 7.0. A 30 mg dose is supplied as 3 vials each containing 1 mL of 10 mg/mL KALBITOR (ecallantide injection) . Each vial contains a slight overfill. Vials are intended for single use. Ecallantide is a 60-amino-acid protein produced in Pichia pastor is yeast cells by recombinant DNA technology.
Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.
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