ecallantide

ecallantide

(ee-kal-lan-tide) ,

Kalbitor

(trade name)

Classification

Therapeutic: antiangioedema agents
Pharmacologic: kallikrein inhibitors
Pregnancy Category: C

Indications

Treatment of acute attacks of hereditary angioedema (HAE) in patients ≥ 16 yr.

Action

Acts as a selective, reversible inhibitor of kallikrein, thereby inhibiting its action in initiating bradykinin production, part of the cascade of events in hereditary angioedema (HAE).

Therapeutic effects

Decreased severity of attack of HAE.

Pharmacokinetics

Absorption: Well absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Renally eliminated.
Half-life: 2 hr.

Time/action profile (symptom improvement)

ROUTEONSETPEAKDURATION
SCunk2–4 hrup to 24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Geriatric: Consider age-related ↓ in hepatic, renal, or cardiac function, concomitant diseases or other drug therapy; lower initial dose may be considered; Lactation: Use cautiously; Obstetric: Use only if clearly needed.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • fatigue

Ear, Eye, Nose, Throat

  • nasopharyngitis

Gastrointestinal

  • nausea (most frequent)
  • abdominal pain
  • diarrhea

Dermatologic

  • pruritus
  • rash
  • urticaria

Local

  • injection site reactions

Miscellaneous

  • hypersensitivity reactions including anaphylaxis, (life-threatening)
  • allergic reactions including anaphylaxis (life-threatening)
  • fever

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Subcutaneous (Adults ≥16 yr) 30 mg given as three 10 mg injections; an additional dose of 30 mg may be given within 24 hr.

Availability

Injection for subcutaneous use: 10 mg/mL

Nursing implications

Nursing assessment

  • Assess for symptoms of hereditary angioedema (submucosal or subcutaneous swelling) before and following treatment.
  • Assess for signs and symptoms of anaphylaxis (chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, hypotension); usually occur within 1 hr of administration.

Potential Nursing Diagnoses

Ineffective breathing pattern (Adverse Reactions)

Implementation

  • Subcutaneous: Use a large bore needle to withdraw ecallantide from vial. Change needles. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Administer three 1 mL (10 mg/mL) injections using a 27 gauge needle into abdomen, thigh, or upper arm for a total dose of 30 mg. Injection site for each of the 3 injections may be in the same or different locations; no need for rotation. Separate injection sites by as least 2 inches from site of angioedema attack. If attack persists, may repeat dose, using same instructions, within 24 hrs.

Patient/Family Teaching

  • Instruct patient in the purpose for ecallantide and the need for administration by health care professional. Advise patient to read Medication Guide prior to administration.
  • Caution patient of the risk for anaphylactic reaction usually within 1 hr of injection. Advise patient to notify health care professional immediately if signs and symptoms of anaphylactic reactions occur.
  • Inform patient that injection site reactions (local pruritus, erythema, pain, irritation, uriticaria, bruising) may occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of an acute attack of hereditary angioedema.
References in periodicals archive ?
PdC1-INH is licensed for children at any age in a dose of 20 IU per kg body weight and rhC1-INH (conestat alfa) or kallikrein inhibitor (ecallantide, only in the USA) for those older than 12 years (14,22).
On-demand treatment can be done with pdC1-INH, icatibant, or ecallantide; the latter is not available in Brazil (2,5,12-16).
[9], deaths were caused by delays in receiving effective emergency treatment and/or not receiving effective drug therapy, i.e., C1INH concentrate, ecallantide, or icatibant.
Acute attacks should be treated with C1-INH concentrate, ecallantide (Kallikrein inhibitor), or icatibant (Bradykinin-receptor antagonist) [15].
Icatibant and ecallantide are targeted at the issue of bradykinin accumulation as the cause of angioedema.
An emergency treatment with the plasma-derived or recombinant C1-INH administered by intravenous infusion at a dose of 20 U/kg can induce an unusually dramatic regression of all symptoms in 30 to 60 minutes.8 Kallikrein inhibitor ecallantide (Kalbitor) and a bradykinin B2 receptor antagonist icatibant (Firazyr) are also approved for the treatment of acute episodes in recent years.
Son zamanlarda yapilan az sayidaki cift kor randomize klinik calismalarda "ecallantide" ve "icatibant" ile elde edilen umut verici sonuclar bildirilmistir.
El icatiban (20, 22) (antagonista del receptor B2 de bradicinina) y ecallantide (21, 22) (inhibidor de la calicreina plasmatica), tambien se han utilizado y demostrado su eficacia en el manejo agudo, pero aun faltan mas estudios que demuestren seguridad y efectividad para ampliar su uso.
16 November 2011 - US Dyax Corp (NASDAQ:DYAX) and Defiante Farmaceutica SA, an affiliate of Italian Sigma-Tau, said on Monday they have decided to withdraw the European Marketing Authorisation Application (MAA) for KALBITOR (ecallantide) in the treatment of hereditary angioedema (HAE).
The hematologic agents are ecallantide (Kalbitor, C) for acute attacks of hereditary angioedema, a rare genetic disorder, and prasugrel (Effient, B) to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention.
Net proceeds from the offering will be used to fund the commercialisation and distribution of KALBITOR (ecallantide), Dyax's lead product that treats acute attacks for hereditary angioedema, as well as to fund other research and preclinical development activities and for general corporate purposes.
The Cubist clinical product pipeline currently consists of ecallantide, a recombinant human protein being developed for the reduction of blood loss during cardiac surgery for which we currently are analyzing Phase 2 data; a Phase 2 program, added with Cubist's acquisition of Calixa Therapeutics in December 2009, focused on the development of a novel cephalosporin to address certain serious infections caused by multi-drug resistant (MDR) Gram-negative organisms; and two Phase 1 programs intended to address unmet medical needs in infectious disease, one for the treatment of CDAD (Clostridium difficile-associated diarrhea) and the other for the treatment of serious infections caused by MDR Gram-negative pathogens.