Support your HAE patients with proven symptom reduction

KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.


Administering KALBITOR

The recommended dose of KALBITOR (ecallantide) is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24-hour period.1

KALBITOR Dosage Form and Strength1

KALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

KALBITOR Administration1

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

Visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.

  • Using aseptic technique, withdraw 1 mL (10 mg) of KALBITOR from the vial using a large bore needle.
  • Change the needle on the syringe to a needle suitable for subcutaneous injection. The recommended needle size is 27 gauge.
  • Inject KALBITOR into the skin of the abdomen, thigh, or upper arm. Repeat the procedure for each of the three vials comprising the KALBITOR dose.
  • The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm). There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.
  • The same instructions apply to an additional dose administered within 24 hours. Different injection sites or the same anatomical location (as used for the first administration) may be used.


Storage & Handling Instructions1

  • KALBITOR (ecallantide) should be refrigerated (2°C to 8°C/36°F to 46°F).
  • Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use.
  • Protect vials from light until use.
  • Do not use beyond the expiration date.

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.

  1. KALBITOR® (ecallantide) Prescribing Information; 2015.