Support your HAE patients with proven symptom reduction

KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.


Proven to Reduce Symptoms During an HAE Attack

KALBITOR (ecallantide) Improved Attack Symptoms at 4 Hours and 24 Hours1

  • The safety and efficacy of KALBITOR were evaluated in 2 randomized, double-blind, placebo-controlled trials (EDEMA3 n=72, EDEMA4 n=96) in 168 patients with HAE1
  • The primary endpoint for the EDEMA4 study was the Mean Symptom Complex Severity (MSCS)a score, a point-in-time measure of symptom severity, at 4 hours; the primary endpoint for the EDEMA3 study was the Treatment Outcome Score (TOS)b, a measure of symptom response to treatment at 4 hours1

MSCS for Patients Taking KALBITOR vs Placebo1

A decrease in MSCS score reflected an improvement in symptom severity; the maximum possible change toward improvement was -3

Change in MSCS score at 4 hours for patients taking KALBITOR vs Placebo

a MSCS: At baseline, and post-dosing at 4 hours and 24 hours, patients rated the severity of each affected symptom on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe). Patient-reported severity was based on each patient’s assessment of symptom impact on his or her ability to perform routine activities. Ratings were averaged to obtain the MSCS score.1

TOS for Patients Taking KALBITOR vs Placebo1

A TOS value >0 reflected an improvement in symptoms from baseline; the maximum possible score was +100

Change in TOS score at 4 hours for patients taking KALBITOR vs Placebo

b TOS: At 4 hours and 24 hours post-dosing, patient assessment of response for each anatomic site of attack involvement was recorded on a categorical scale (significant improvement [100], improvement [50], same [0], worsening [-50], significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS.1

Important Safety Information

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 HAE.
  • Healthcare professionals should be aware of similarity of symptoms between hyper sensitivity reactions and HAE patients should be monitored closely.
  • Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.

Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR

WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions, Including Anaphylaxis
Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical trials, 10 patients (4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (3%) experienced anaphylaxis. These reactions occurred within the first hour after dosing.

Symptoms associated with hypersensitivity reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension.

Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5%), rash (3%), and urticaria (2%).

Patients should be observed for an appropriate period of time after administration of KALBITOR, taking into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.

The most common adverse reactions (≥3% and greater than placebo) in HAE patients were headache (8%), nausea (5%), diarrhea (4%), pyrexia (4%), injection site reactions (3%), and nasopharyngitis (3%).

There is a potential for immunogenicity with the use of KALBITOR. Overall, 20.2% of patients seroconverted to anti-ecallantide antibodies. Patients who seroconvert may be at a higher risk of a hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.

Please see the Full Prescribing Information, including Boxed Warning.

  1. KALBITOR® (encallantide) Prescribing Information; 2015.