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Ecallantide

Published: July 26, 2026Updated: July 26, 2026

Ecallantide is a kallikrein inhibitor used to treat acute attacks of hereditary angioedema (HAE) in patients aged 12 years and older with C1-esterase-inhibitor (C1-INH) deficiency. It is administered as a subcutaneous injection and works by inhibiting the enzyme kallikrein, which reduces the production of bradykinin—a key mediator responsible for swelling and inflammation in HAE attacks.

Quick summary

Ecallantide is an injectable medication for acute hereditary angioedema attacks that works by inhibiting kallikrein to reduce bradykinin-mediated swelling.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
B06AC03
RxNorm
658708
Generic
Ecallantide
Class
atc-b06
Brands
Kalbitor
Availability
rx
Lactation
unknown
Routes
—
Forms
injection
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses up to 80 mg have been administered in clinical studies; however, doses significantly exceeding the recommended 30 mg may increase risk of adverse effects
Chronic overdose: Limited data available on cumulative toxicity; repeated dosing should follow prescribed intervals
Immediate actions
Discontinue drug administration, monitor vital signs, provide supportive care, airway management if needed, antihistamines and corticosteroids as appropriate
Antidote
No specific antidote available(Supportive care is the primary treatment; no specific antidote exists)
Poison Control: 1-800-222-1222

Special Populations

7 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if clearly needed and benefits outweigh potential risks

Monitor

regular fetal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second third trimester
caution
FDA Category
C
Dose Adjustment

use lowest effective dose

Key Recommendations

continue only if benefits outweigh risks

Monitor

routine prenatal monitoring

Use with caution and monitor for adverse effects.

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

no adjustment recommended

Key Recommendations

decide whether to discontinue nursing or stop drug based on importance to mother

Monitor

monitor infant for adverse effects

✓

pediatric_age

adolescents 12 to 17
safe
FDA Category
C
Dose Adjustment

same as adult dosing

Key Recommendations

approved for patients 12 years and older

Monitor

standard monitoring for adverse reactions

⚠

geriatric

elderly 65 and older
caution
FDA Category
C
Dose Adjustment

no specific dose adjustment

Key Recommendations

use with caution due to limited clinical experience

Monitor

monitor renal and hepatic function

Use with caution and monitor for adverse effects.

⚠

renal_impairment

moderate to severe
caution
FDA Category
C
Dose Adjustment

no specific adjustment needed

Key Recommendations

use with caution; limited clinical data available

Monitor

monitor renal function periodically

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
C
Dose Adjustment

no specific adjustment needed

Key Recommendations

use with caution; limited clinical data available

Monitor

monitor hepatic function periodically

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2014

FDA approval for acute hereditary angioedema treatment

drug_classWHO
2023

Drug class

Value:Kallikrein inhibitor

Proteinase inhibitor class

usageMedical guidelines
2023

Common uses

Value:Acute hereditary angioedema attacks

Treatment of HAE in patients 12 years and older

administrationFDA
2023

Route of administration

Value:Subcutaneous

Subcutaneous injection administration

Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older with C1-esterase-inhibitor (C1-INH) deficiency. It is specifically indicated for on-demand treatment of acute attacks and is not used for prophylactic therapy.

Ecallantide is a recombinant protein that directly inhibits kallikrein, a key enzyme in the kinin system. By blocking kallikrein, it prevents the conversion of kininogen to bradykinin, thereby reducing the vasodilation and increased vascular permeability that cause the swelling and pain characteristic of HAE attacks.

Ecallantide is administered as three subcutaneous injections (each 10 mg/mL) in the abdominal region. It carries a boxed warning for anaphylaxis, which has been observed in approximately 4% of patients in clinical trials. Healthcare providers should observe patients for at least one hour after administration. It is contraindicated in patients with known hypersensitivity to ecallantide or any of its components.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy