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 ?
Icatibant and ecallantide are targeted at the issue of bradykinin accumulation as the cause of angioedema.
Outcomes after ecallantide treatment of laryngeal hereditary angioedema attacks.
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.
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.
25 per basic and diluted share net of tax, respectively, related to the in-licensing from Dyax Corporation of ecallantide for surgical indications.
3 December 2009 - US Cubist Pharmaceuticals Inc (NASDAQ: CBST) announced today that it completed earlier the enrollment of patients in the Phase II programme of its drug candidate ecallantide.
Both presentations pooled results from patients enrolled in four different clinical trials of ecallantide for the treatment of acute HAE attacks: DX-88/19, an open-label continuation study; EDEMA2[R], an open-label, Phase 2 dose-ranging, repeat-dosing study; and EDEMA3[R] and EDEMA4[R], two Phase 3 double-blind, placebo-controlled studies.
The Company's lead product, ecallantide, has been approved under the brand name KALBITOR in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
The 2012 research and development expenses primarily relate to the following Dyax research and development initiatives: 1) KALBITOR post-marketing requirements; 2) development of a single-injection formulation of KALBITOR; 3) a clinical study of the use of ecallantide for the treatment of ACE inhibitor-induced angioedema, including costs related to the discontinuation and close-out of Dyax's Phase 2 study in this indication; 4) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein; and 5) pass-through license fees paid by Dyax licensees under the LFRP.
The Company's lead product, ecallantide, has been approved under the brand name KALBITOR([R]) in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
NASDAQ: DYAX) announced today the decision to discontinue the Company's Phase 2 trial investigating ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema based upon the results of an interim analysis.
The Company's lead product, ecallantide, has been approved under the brand name KALBITOR[R] in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.