ecallantide

(redirected from Kalbitor)

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 ?
The company has already successfully developed and commercialised Kalbitor, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment.
Dyax has already successfully developed and commercialized Kalbitor, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment.
Dyax already has one HAE drug on the market, called Kalbitor, but its sales totaled only $68 million last year and consensus analyst forecasts do not predict it will exceed annual sales of $100 million, according to Thomson Reuters Cortellis.
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.
M2 PHARMA-November 16, 2011-Dyax, Defiante withdraw European filing for KALBITOR for HAE(C)2011 M2 COMMUNICATIONS
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.
Avecia spokeswoman Bridget Hall said that drug, soon to be launched under the brand name Kalbitor, is for swelling in the extremities.
Based on drug class, the market has been segmented into C1-inhibitors (C1-esterase Inhibitor, Recombinant Inhibitor); Kallikrein Inhibitor (Kalbitor); Selective Bradykinin B2 Receptor Antagonist (Firazyr).
Total net revenue jumped to USD10.1m from USD7m on higher KALBITOR net sales.