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 Care®
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 Services®
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 12 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.
Please note:

The web site you are about to visit is neither owned nor controlled by Dyax Corp. Dyax is not responsible for the content, products or services on this site.

Do you wish to continue?

Please note:

You are about to leave the KALBITOR website to visit another
site that contains Dyax-managed content.

Do you wish to continue?

Strength that Lasts

KALBITOR® (ecallantide) is the only subcutaneous acute hereditary angioedema (HAE) attack treatment that is proven to treat HAE attack symptoms at 4 hours and provide continuous improvement through 24 hours.

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

Hypersensitivity Reactions

Warnings and Precautions: Drug Hypersensitivity including Anaphylaxis in Clinical Trials

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred during clinical trials in patients treated with KALBITOR® (ecallantide) at the recommended subcutaneous dose.1

KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.

Drug hypersensitivity in clinical trials

  • Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension.1
  • These reactions occurred within the first hour after dosing.1
  • Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5%), rash (3%), and urticaria (2%).1
  • 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.1
  • Given the similarity of hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.1
  • KALBITOR should not be administered to any patients with known clinical hypersensitivity to KALBITOR.1
References
1 KALBITOR® (ecallantide) Full Prescribing Information, Dyax Corp., Burlington, Massachusetts, March 2014. 
   
   

Print Page |

Please make sure to read
Important Safety
Information for KALBITOR.

SAFETY INFORMATION

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

request a call

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

Learn More
 
 
 
KALBITOR® (ecallantide) is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
EXPAND 
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 the similarity of symptoms between hypersensitivity reactions and HAE 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 (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 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 a 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. Overall, 20.2% of patients seroconverted to anti-ecallantide antibodies. Anti-ecallantide IgE antibodies were detected at a rate of 4.7% for tested patients, and anti-P. pastoris IgE antibodies were also detected at a rate of 20.2%. Patients who seroconvert may be at a higher risk of a 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 12 years of age have not been established.

Please see the 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.