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Ecallantide

Pronunciation

(e KAL lan tide)

Index Terms

  • DX-88

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Kalbitor: 10 mg/mL (1 mL)

Brand Names: U.S.

  • Kalbitor

Pharmacologic Category

  • Kallikrein Inhibitor

Pharmacology

Ecallantide is a recombinant protein which inhibits the conversion of high molecular weight kininogen to bradykinin by selectively and reversibly inhibiting plasma kallikrein. Unregulated bradykinin production is thought to contribute to the increased vascular permeability and angioedema observed in HAE.

Distribution

Vd: 26.4 ± 7.8 L

Excretion

Primarily urine

Onset of Action

30 minutes to 4 hours (Epstein 2008)

Time to Peak

~2 to 3 hours

Half-Life Elimination

2 ± 0.5 hours

Use: Labeled Indications

Hereditary angioedema: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years and older

Contraindications

Hypersensitivity to ecallantide or any component of the formulation

Dosage

Hereditary angioedema (HAE) treatment: Children ≥12 years, Adolescents, and Adults: SubQ: 30 mg (as three 10 mg [1 mL] injections); if attack persists, may repeat an additional 30 mg within 24 hours

Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Administer as 3 (10 mg/mL each) injections subcutaneously into skin of abdomen, upper arm, or thigh (do not administer at site of attack). Recommended needle size is 27 gauge. Separate injections by 2 inches (5 cm). May inject all doses in same or different location; rotation of sites is not necessary. Monitor/observe for hypersensitivity.

Storage

Store at 2°C to 8°C (36°F to 46°F). Protect from light. May be stored for up to 14 days at <30°C (<86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Central nervous system: Headache (8% to 16%), fatigue (12%)

Gastrointestinal: Nausea (5% to 13%), diarrhea (4% to 11%)

Immunologic: Antibody development (IgE: 5% to 20%; neutralizing: 9%)

1% to 10%:

Dermatologic: Pruritus (5%), skin rash (3%), urticaria (2%)

Gastrointestinal: Vomiting (6%), upper abdominal pain (5%)

Hypersensitivity: Anaphylaxis (4%)

Local: Injection site reaction (3% to 7%; includes bruising, erythema, irritation, pain, pruritus, urticaria)

Respiratory: Upper respiratory tract infection (8%), nasopharyngitis (3% to 6%)

Miscellaneous: Fever (4% to 5%)

<1% (Limited to important or life-threatening): Hypersensitivity reaction (chest discomfort, flushing, pharyngeal edema, rhinorrhea, sneezing, nasal congestion, throat irritation, wheezing, hypotension)

ALERT: U.S. Boxed Warning

Hypersensitivity reactions:

Anaphylaxis has been reported after administration of ecallantide. Because of the risk of anaphylaxis, ecallantide should only be administered by a health care provider with appropriate medical support to manage anaphylaxis and hereditary angioedema. Health care providers should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema, and patients should be monitored closely. Do not administer ecallantide to patients with known clinical hypersensitivity to ecallantide.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: [U.S. Boxed Warning]: Serious hypersensitivity reactions, including anaphylaxis have been reported; administer only by healthcare provider in presence of appropriate medical support to manage anaphylaxis and hereditary angioedema. Do not administer to patients with known hypersensitivity to ecallantide. Reactions usually occur within 1 hour and may include chest discomfort, flushing, hypotension, nasal congestion, pharyngeal edema, pruritus, rash, rhinorrhea, sneezing, throat irritation, urticaria, and wheezing. Signs/symptoms of hypersensitivity reactions may be similar to those associated with hereditary angioedema attacks, therefore, consideration should be given to treatment methods; monitor patients closely.

• Immunogenicity: Some patients may develop antibodies to ecallantide during therapy; seroconversion may increase the risk of hypersensitivity reaction.

Monitoring Parameters

Monitor for hypersensitivity reaction

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. If treatment for HAE is needed during pregnancy, other agents are preferred (Caballero, 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, nausea, vomiting, diarrhea, itching, pharyngitis, or rhinitis. Have patient report immediately to prescriber signs of infection, severe injection site irritation, dysphagia, shortness of breath, severe dizziness, passing out, tachycardia, anxiety, flushing, rhinorrhea, or sneezing (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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