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?

Your Patients Don't Have to Go it Alone

KALBITOR® (ecallantide) is the treatment that comes with care so your patients aren't alone in managing their acute hereditary angioedema (HAE) attacks. KALBITOR Care® can also help you manage your patients more closely.

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

Treatment Support

Service and Support Options

Hereditary angioedema (HAE) attacks are unpredictable and can be severe. Immediate access to on-demand treatment for acute HAE attacks is critical to your KALBITOR®(ecallantide) patients. When you prescribe KALBITOR, you and your patients automatically receive the comprehensive support of KALBITOR Care® to help you arrange a complete treatment plan for your patients. Our services are provided through KALBITOR Access® and include:

  • KALBITOR home delivery. Patients with HAE who have prescriptions for KALBITOR can have it shipped directly to their homes. Patients can then bring KALBITOR with them to a treatment center that was selected and set up in advance to be treated by a healthcare professional during an acute HAE attack. KALBITOR is not approved for self-administration.

  • Personalized nurse support. When you enroll your patient in KALBITOR Access, they will be assigned to a personal nurse, who will ensure that your patient receives the appropriate support throughout their experience with KALBITOR.

  • Health insurance support and research. Our health insurance specialists will research your patients’ health insurance benefits to identify their coverage for KALBITOR treatment and documentation requirements. If documentation or an appeal is required, our staff will work with your office to coordinate the health plan approval.

  • Financial assistance. All patients are evaluated for financial assistance. Qualified patients may be eligible for the following:
    • KALBITOR free of charge
    • Charitable foundation assistance to subsidize the cost of health insurance premiums and copay assistance.
    • Expanded Copayment Assistance and KALBITOR Access Card programs: Eligible patients with a KALBITOR prescription for on-demand treatment of acute HAE attacks may receive financial assistance for treatment-related expenses not currently covered by health insurance, including copayment, co-insurance, and/or deductibles, as well as transportation costs to and from the treatment site.
  • Billing/coding support. KALBITOR Access can provide billing and coding support for your office staff whether you stock the drug through the Specialty Pharmacy (also referred to as patient-specific, or patient-named, product) or the buy-and-bill option.

  • KALBITOR Home Infusion Services®. Eligible patients have the option to receive KALBITOR subcutaneous injection treatment in their own homes, administered by an experienced infusion nurse. KALBITOR Home Infusion Services is not appropriate for treating laryngeal attacks. This service also provides:

KALBITOR is not approved for self-administration and should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.

KALBITOR Home Infusion Services is administered by a third party infusion services provider. Dyax Corp. does not provide these services. 

As part of KALBITOR Care, a dedicated program staff of health insurance specialists and nurses is available to you and your patients at 1-888-4KALBITOR (1-888-452-5248), 24 hours a day, 7 days a week.

To ensure KALBITOR is available to treat your HAE patient's next attack, enroll your patient in KALBITOR Access. Click here for more information on enrolling a patient.

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

Ready to get your patients started on KALBITOR? Print the Start Form to begin the enrollment process.

GET STARTED
 
 
 
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.