Acute attacks
Sudden attacks of hereditary angioedema.
Clinical trials
Studies that evaluate the effectiveness and safety of medications or medical devices before they are approved for use by the general public.
Ecallantide (e-KAL-lan-tide)
A protein made in yeast cells; ecallantide is the active ingredient in KALBITOR (ecallantide).
HAE
Abbreviation for hereditary angioedema.
Hereditary Angioedema
A rare, hereditary disease of the immune system that causes attacks of sudden swelling in various parts of the body.
KALBITOR Access®
KALBITOR Access is a program that provides support services to hereditary angioedema patients, healthcare professionals and caregivers. KALBITOR Access services include health insurance coordination, financial assistance for qualified patients, and treatment location set up.
KALBITOR CareSM
KALBITOR Care is a program offered by Dyax Corp. that provides comprehensive support services for KALBITOR patients. Available 24 hours a day, 7 days a week, KALBITOR Care offers a complete array of patient services and resources, along with the support of healthcare professionals.
KALBITOR Home Infusion ServicesSM
KALBITOR Home Infusion Services is a program in which an experienced infusion nurse will administer your subcutaneous KALBITOR treatment in the comfort of your own home. This professional service is available to HAE patients, 16 years of age or older, who use KALBITOR to treat their sudden HAE attacks on demand. KALBITOR Home Infusion Services is not appropriate for treating laryngeal attacks.
KALBITOR® (KAL-bit-or)
A prescription medicine used to treat sudden attacks of hereditary angioedema in patients 16 years of age and older. KALBITOR® is not a cure for HAE.
Laryngeal attack
An HAE attack that affects the larynx (throat); this can block or close the airway, leading to difficulty breathing and, potentially, death.
Larynx
The part of the throat that contains the vocal cords and is used for breathing, swallowing, and talking.
On-demand treatment
On-demand HAE treatment is used to treat sudden attacks of HAE as they occur, in order to relieve symptoms associated with the attack. On-demand treatment is not used to prevent attacks from occurring.
Plasma kallikrein (kal'i-kre'in)
A protein in the body that triggers the release of a substance that may lead to hereditary angioedema attack symptoms.
Subcutaneous
Under the skin.
Trigger
In hereditary angioedema, something that causes an attack.
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Should I just wait this attack out?

When your patients have acute HAE attacks, this may be their first question. With the help of KALBITOR CareSM, an effective on-demand treatment is available.

Please see Full Prescribing Information, including Boxed Warning and Medication Guide.

KALBITOR® (ecallantide) Efficacy at 4 Hours

The safety and efficacy of KALBITOR were evaluated in 2 randomized, double-blind, placebo-controlled trials (EDEMA4® and EDEMA3®) in 143 unique patients with hereditary angioedema (HAE).

In clinical trials, KALBITOR demonstrated rapid improvement of acute attack symptoms at 4 hours.12 

Patients Treated with KALBITOR Achieved Significant Improvement in MSCS Scores12,13,16 *

Mean Symptom Complex Severity (MSCS) score is a point-in-time measure of symptom severity. A decrease in MSCS score reflected an improvement in symptoms.

The primary endpoint for EDEMA3 is TOS and for EDEMA 4 is MSCS.Patients who participated in both studies were included only once in accordance with the prospective analysis plan.

  • *MSCS score is a point-in-time measure of symptom severity:
    • At baseline, 4 hours, and 24 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location.
    • Ratings were averaged to obtain the MSCS score.
    • A decrease in MSCS score reflected an improvement in symptoms.
  • †ITT-as-treated population. No data imputations. P value from Wilcoxon rank sum test.
  • ‡The integrated phase 3 analysis included the data from EDEMA3 pooled with data from EDEMA4. The similarities between these 2 studies justify pooling of the data to assess treatment effects in a larger patient group in this rare disease.
    The 95% confidence intervals (CIs) for EDEMA4 at 4 hours were -1.0 to -0.6 (KALBITOR) and -0.6 to -0.1 (placebo), for EDEMA3 at 4 hours were -1.4 to -0.8 (KALBITOR) and -0.8 to -0.4 (placebo), and for integrated studies at 4 hours were -1.2 to -0.8 (KALBITOR) and -0.6 to -0.3 (placebo).
    Placebo treatment consisted of 3 subcutaneous 1-mL injections of phosphate buffered solution. Supportive care such as IV fluids or medication for pain and nausea were permitted. If the investigator judged patients at risk after the initial dose of study drug, patients in the placebo arm were permitted to receive standard care (defined as C1-INH, where available, fresh frozen plasma, high dose androgens, or a single open-label dose of KALBITOR). Patients who received additional HAE medications within 4 hours were censored from the analysis.

Patients Treated with KALBITOR Achieved Clinically and Statistically Significant Improvement in Mean Treatment Outcome Score (TOS) at 4 Hours12,13,16 *

Treatment Outcome Score (TOS) is a measure of symptom response to treatment. A TOS value >0 reflected an improvement in symptoms from baseline.

  • *TOS is a measure of symptom response to treatment:
    • At 4 hours and 24 hours, patient assessment of response, characterized by their change from baseline in symptom severity and collected by 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.
    • A TOS value >0 reflected an improvement in symptoms from baseline.
  • †The integrated phase 3 analysis included the data from EDEMA3 pooled with data from EDEMA4. The similarities between these 2 studies justify pooling of the data to assess treatment effects in a larger patient group in this rare disease.
    The 95% CIs for EDEMA4 at 4 hours were 39 to 68 (KALBITOR) and -12 to 28 (placebo), for EDEMA3 at 4 hours were 49 to 76 (KALBITOR) and 17 to 54 (placebo), and for integrated studies were 44 to 67 (KALBITOR) and 6 to 34 (placebo).

Examine the results of KALBITOR's efficacy at 24 hours.

References
12 KALBITOR® (ecallantide) Full Prescribing Information, Dyax Corp., Burlington, Massachusetts, February 2012.
13 Levy RJ, Lumry WR, et al. EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedema. Annals of Allergy, Asthma, & Immunology. 2010;104:523-529.
16 Sheffer AL, Campion M, Levy RJ, Li HH, Horn PT, Pullman WE. Ecallantide (DX-88) for acute hereditary angioedema attacks: Integrated analysis of 2 double-blind, phase 3 studies. J Allergy Clin Immunol. 2011;128:153-9.

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Important Safety
Information for KALBITOR.

SAFETY INFORMATION

Questions about KALBITOR? Request a call from a Dyax Corp. representative for more information.

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Learn how KALBITOR Care can help you prepare a treatment plan for your patient’s next acute HAE attack.

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KALBITOR subcutaneous injection is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
Important Safety Information EXPAND ›

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.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical trials, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) experienced anaphylaxis. These reactions occurred within the first hour after dosing.

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

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 hypersensitivity reaction.

ADVERSE EVENTS

The most common adverse events (≥3% and greater than placebo) in HAE patients were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis. There is a potential for immunogenicity with the use of KALBITOR. Patients who seroconvert may be at a higher risk of hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.

USAGE

KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Safety and effectiveness of KALBITOR in patients below 16 years of age have not been established.

Please see Full Prescribing Information, including Boxed Warning and Medication Guide.

Healthcare professionals should report all suspected adverse events associated with the use of KALBITOR. Please contact Dyax Corp. at 1-888-452-5248. Alternatively, this information may be reported to the FDA MedWatch System by phone at 1-800-FDA-1088 or by mail using Form 3500 at www.fda.gov/medwatch.