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)
]
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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.
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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.
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.
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 >>
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Page last updated: 2013-02-10
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