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Kalbitor (Ecallantide) - Summary



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 (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 >>


Published Studies Related to Kalbitor (Ecallantide)

Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. [2015]
fails... CONCLUSION: The results from this preliminary study reveal that ecallantide is

Ecallantide for the acute treatment of angiotensin-converting enzyme inhibitor-induced angioedema: a multicenter, randomized, controlled trial. [2015]
inhibitor-induced angioedema (ACEIA) in an emergency department (ED)... CONCLUSION: The addition of ecallantide to standard therapy does not appear to

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

more studies >>

Clinical Trials Related to Kalbitor (Ecallantide)

Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema [Completed]
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 [Terminated]
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement [Terminated]
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.

Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) [Completed]
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema [Withdrawn]

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: 2015-08-10

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