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Kalbitor (Ecallantide) - Summary

 
 



WARNING: ANAPHYLAXIS

Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR 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 to patients with known clinical hypersensitivity to KALBITOR. [see Contraindications (4), Warnings and Precautions , and Adverse Reactions (6) ]

 

KALBITOR SUMMARY

KALBITOR (ecallantide) is a human plasma kallikrein inhibitorfor injection for subcutaneous use.

KALBITOR (ecallantide) is indicated fortreatment of acute attacks of hereditary angioedema (HAE) in patients 16 yearsof age and older.


See all Kalbitor indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Kalbitor (Ecallantide)

Ecallantide for treatment of acute hereditary angioedema attacks: analysis of efficacy by patient characteristics. [2012]
Hereditary angioedema (HAE) is characterized by episodic attacks of edema. HAE is caused by low levels of the protein C1 esterase inhibitor, which inhibits plasma kallikrein, the enzyme responsible for converting high-molecular-weight kininogen to bradykinin.However, the standard dose was less effective for obese patients.

Prospective, double-blind, placebo-controlled trials of ecallantide for acute attacks of hereditary angioedema. [2012]
Hereditary angioedema (HAE) is a rare genetic disorder characterized by unpredictable, episodic, incapacitating attacks of well-demarcated angioedema in the absence of urticaria and pruritus. HAE is due to deficient or dysfunctional C1-esterase inhibitor activity, which results in unopposed activation of plasma kallikrein, resulting in increased levels of bradykinin.

A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial). [2012]
associated with cardiac surgery requiring cardiopulmonary bypass... CONCLUSIONS: Ecallantide was less effective at reducing perioperative blood loss

Ecallantide (DX-88) for acute hereditary angioedema attacks: integrated analysis of 2 double-blind, phase 3 studies. [2011.07]
BACKGROUND: Hereditary angioedema (HAE) is a rare disorder characterized by recurrent angioedema attacks. Ecallantide, a novel plasma kallikrein inhibitor, inhibits production of bradykinin, the key mediator of these angioedema attacks. OBJECTIVE: We sought to further characterize the safety and efficacy of ecallantide for HAE attacks by performing an integrated analysis of pooled data from 2 phase 3 studies... CONCLUSIONS: This integrated analysis supports and expands on the results of the phase 3 studies. Ecallantide appears to be effective and well tolerated for the treatment of HAE attacks. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Response to ecallantide treatment of acute attacks of hereditary angioedema based on time to intervention: results from the EDEMA clinical trials. [2011]
Hereditary Angioedema (HAE) is a rare, debilitating, genetic disorder characterized by acute attacks of edema without urticaria... Treatment with ecallantide within 6 hours of symptom onset leads to more rapid and sustained improvement of symptoms.

more studies >>

Clinical Trials Related to Kalbitor (Ecallantide)

Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema [Recruiting]
The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).

Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema [Recruiting]
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema [Not yet recruiting]

Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema [Recruiting]
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.

Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion [Recruiting]
The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

more trials >>

Reports of Suspected Kalbitor (Ecallantide) Side Effects

Hereditary Angioedema (25)Hypersensitivity (6)Drug Ineffective FOR Unapproved Indication (6)Pulmonary Embolism (6)Anaphylactic Reaction (5)Pancreatitis (5)Hypertension (5)Blood Glucose Increased (4)Angioedema (4)Feeling Abnormal (4)more >>


Page last updated: 2013-02-10

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