KALBITOR Access®

Support for You and Your Patient

New Option: KALBITOR Home Infusion Services^SM

When your patients have an acute hereditary angioedema (HAE) attack, it can mean an unplanned trip to an allergist, an urgent care facility, or a hospital emergency room. Now, with KALBITOR Home Infusion Services, patients have the option to receive KALBITOR^® (ecallantide) subcutaneous injection treatment in their own homes. Learn more about KALBITOR Home Infusion Services.

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

KALBITOR Access^®

Because of the unpredictable and potentially severe nature of acute HAE attacks, it is important that your KALBITOR patients have treatment available and accessible before an acute attack occurs. KALBITOR Access is a support services program designed for you and your patients to ensure you have the assistance you need.

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 Access provides the following services:

KALBITOR shipped directly to the home of your patients
Health insurance support
Financial assistance for eligible patients
Billing and coding support
KALBITOR^® Extended Payment Program for Physicians

A dedicated program staff of health insurance specialists and nurses are 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 patients’ next attack, enroll your patients in KALBITOR Access. Click here for more information on enrolling a patient.

Learn more about patient support services.

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 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.

kalbitor ecallantide