Product Support for Your HAE Patients

OnePath® provides support to your patients throughout their treatment journey with KALBITOR.

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

OnePath Product Support Services

OnePath® logo

OnePath supports eligible patients by helping to remove access barriers when starting their KALBITOR® (ecallantide) therapy, and by assisting them throughout their treatment.

This product support includes:

  • Facilitating an insurance benefits investigation
  • Working with specialty pharmacies (SPs) to coordinate treatment access for patients
  • Arrange for home infusion services and treatment site set-up.§
  • Enrolling eligible patients in the OnePath Co-Pay Assistance Program or providing information about other financial assistance options
  • Directing patients and caregivers to educational resources available to them

OnePath understands that communication is key. Translation services are available for non–English-speaking patients and caregivers. In addition, OnePath offers some materials and resources in Spanish.

§ KALBITOR is not approved for self-administration and should only be administered by a doctor or nurse with appropriate support to manage serious allergic reactions and HAE. KALBITOR Home Infusion Services is not appropriate for treating laryngeal attacks. This service is administered by a third-party infusion services provider.

Enrolling in OnePath

Step 1

Your office completes the OnePath Start Form.

Step 2

A Patient Support Manager (PMS) calls your enrolled patient to discuss OnePath services and connects them with their Onboarding and Access Specialist (OAS), their primary OnePath contact.

Step 3

OnePath determines coverage and presents financial options. The OAS can meet in person to help resolve insurance or financial access challenges, and assist with prior authorizations, appeals, and reverifications.

Step 4

Once your patient’s benefits are approved, they may be treated with KALBITOR by a trained nurse in the comfort and convenience of their home or preferred treatment location.

Step 5

The PSM continues to provide product support and educates your office about reauthorizations, if required. Your patient should let OnePath know about any changes or life events that may affect his or her insurance.

The KALBITOR Home Infusion Services® program provides nurse home visits to administer treatment to patients.

  • An initial clinical consultation includes patient education related to the infusion services and review of product label and information
  • Nurses will then visit as necessary to assess and administer KALBITOR as prescribed
    • Nurses will also provide treatment for hypersensitivity reactions should they occur during the visit
  • Patients will be directed to the closest emergency facility for life-threatening HAE attacks including, but not limited to, laryngeal attacks

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.