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Ecallantide

Medically reviewed by Drugs.com. Last updated on Jul 5, 2020.

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

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hereditary angioedema (HAE), treatment:

Children 8 to <12 years of age: Limited data available (Frank 2016): SubQ: 30 mg (as three 10 mg [1 mL] injections); dosing based on data pooled from 4 clinical studies (n=29, ages 9 to 17 years including 25 who received at least 1 dose of ecallantide) (MacGinnitie 2013) and a single case report in an 8-year-old (Dy 2013); efficacy was observed with no adverse events reported.

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

Administration

SubQ: 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. Should only be administered by a health care professional; not for self-administration.

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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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%, postmarketing, and/or case reports: 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: [US Boxed Warning]: Serious hypersensitivity reactions, including anaphylaxis have been reported; administer only by health care 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.

Other warnings/precautions:

• Appropriate use: The role of ecallantide in the management of patients with ACEI-induced angioedema is controversial (Bernstein 2015; Lewis 2015).

Monitoring Parameters

Monitor for hypersensitivity reaction

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. If treatment for hereditary angioedema (HAE) is needed during pregnancy, other agents are recommended (WAO/EEACI [Maurer 2018]).

Patient Education

What is this drug used for?

• It is used to treat swelling attacks in people with hereditary angioedema (HAE).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Loss of strength and energy

• Nausea

• Vomiting

• Common cold symptoms

• Sore throat

• Throat irritation

• Diarrhea

• Abdominal pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe injection site irritation

• Trouble swallowing

• Shortness of breath

• Dizziness

• Passing out

• Fast heartbeat

• Abnormal heartbeat

• Anxiety

• Flushing

• Runny nose

• Stuffy nose

• Sneezing

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions