What is Kalbitor used for?

• Kalbitor (ecallantide) is used to treat acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.
• Kalbitor is a potent, selective, and reversible inhibitor of kallikrein.
• Kalbitor binds to kallikrein and prevents it from making bradykinin.
• Bradykinin is thought to be responsible for the characteristic symptoms of angioedema attacks seen in HAE.

Kalbitor (ecallantide) is used to treat the symptoms of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.

Hereditary angioedema is a genetic disorder that causes attacks of swelling severe swelling in the limbs, face, intestinal tract, and airway.

Kalbitor is a potent, selective, and reversible inhibitor of kallikrein. Kalbitor binds to kallikrein and prevents it from making bradykinin. Bradykinin is thought to be responsible for the characteristic symptoms of angioedema attacks seen in HAE.

How is Kalbitor administered?

Kalbitor is administered by a trained health professional experienced at treating HAE. It is administered by subcutaneous (under the skin) injection into the abdominal area.

Kalbitor should only be given by a health professional because it carries a risk of anaphylaxis (severe allergic reaction).

What is the dosage of Kalbitor?

The recommended dosage of Kalbitor is 30mg. This is usually given as three 10mg/1ml injections under the skin.

If the attack persists, an additional dose of 30mg may be given within 24 hours. Kalbitor needs to stored in the refrigerator and protected from light.

What are the side effects of Kalbitor?

Anaphylaxis has been reported after Kalbitor administration, occurring in 3-4% of patients in clinical trials and occurring within the first hour of dosing.

Anaphylaxis may be difficult to distinguish from the symptoms of an acute attack of HAE, because the symptoms are so similar. Symptoms of anaphylaxis associated with Kalbitor include chest discomfort, flushing, edema of the throat, itching, nasal congestion and sneezing, wheezing and low blood pressure.

Other common side effects of Kalbitor include:

• Abdominal pain
• Diarrhea
• Fatigue
• Fever
• Headache
• Itching
• Nausea
• Soreness and redness around the injection site
• Upper respiratory tract infections
• Vomiting.

What is hereditary angioedema?

Hereditary angioedema is a genetic disorder characterized by severe swelling in the limbs, face, intestinal tract, and airway. There are three known types: Type I and II caused by mutations in the Serping I gene and Type III which is caused by mutations in the F12 gene.

The Serping I gene provides instructions for making the C1 inhibitor protein, which helps control inflammation. Mutations in this gene can lead to either reduced levels of C1 protein in the blood or the production of a C1 inhibitor that functions abnormally. When levels of this C1 protein are decreased, excessive amounts of another protein fragment, called bradykinin are generated. Bradykinin increases the leakage of fluid through the walls of blood vessels into body tissues, promoting inflammation. This causes fluid to accumulate which causes the swelling characteristic of hereditary angioedema type I and type II.

Some cases of hereditary angioedema type III are associated with mutations in the F12 gene. This gene codes for an important protein that helps our blood to clot, known as coagulation factor XII. Factor XII is also an important stimulator of inflammation and is involved in bradykinin production. Certain F12 mutations produce Factor XII with an increased activity, which generates more bradykinin, leading to blood vessel wall leakage and angioedema. The gene mutations responsible for other types of hereditary angioedema III have not yet been discovered.