Ecallantide Brand Name– Kalbitor
What is Ecallantide
Ecallantide (Kalbitor, DX-88) is a kallikrein inhibitor used for the treatment of acute hereditary angioedema (HAE) attacks and is under investigation for the reduction of blood loss during cardiothoracic surgery.
It is a 60-amino acid recombinant protein produced in Pichia pastoris yeast cells.
Hereditary angioedema is a rare, genetic syndrome that causes nonpitting, nonpruritic edema in most parts of the body, although attacks are most common in the face, limbs, genitalia, and gastrointestinal mucosa. If an HAE attack involves the larynx or oropharynx, the attack can be life-threatening and ventilatory support of the patient may be needed.
During clinical trials, ecallantide has demonstrated an improved extent of and time to resolution of HAE symptoms during an attack.
If symptoms persist or relapse after the initial ecallantide dose, a second dose may be administered within 24 hours.
Although responses have been reported after the second ecallantide dose, efficacy of the second dose was not systematically assessed in the initial clinical trials.
Enrollment in two phase II trials investigating the use of ecallantide for the reduction of blood loss during cardiothoracic surgery was temporarily suspended in December 2009 after a data safety monitoring board found a higher incidence of death in the ecallantide treated patients.
It should be noted that overall mortality appeared to be consistent with the expected outcomes for the patient population.
- hereditary angioedema
For the treatment of acute attacks of hereditary angioedema (HAE)
Side Effects
- abdominal pain
- antibody formation
- chest pain (unspecified)
- diarrhea
- erythema
- fatigue
- fever
- flushing
- headache
- hypotension
- infection
- injection site reaction
- nasal congestion
- nausea
- pharyngitis
- pruritus
- rash
- rhinorrhea
- serious hypersensitivity reactions or anaphylaxis
- sneezing
- throat irritation
- urticaria
- vomiting
- wheezing
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- children
- ecallantide hypersensitivity
- geriatric
- infants
- neonates
- pregnancy
- requires an experienced clinician
- serious hypersensitivity reactions or anaphylaxis
Interactions
There are no drug interactions associated with Ecallantide products.
