Ecallantide

Ecallantide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

ANAPHYLAXIS: See full prescribing information for complete Boxed Warning. ANAPHYLAXIS: Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.

Overview

Ecallantide is a Immune Modulator that is FDA approved for the treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

Dosage

The recommended dose of KALBITOR is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

3  DOSAGE FORMS AND STRENGTHS KALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ecallantide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ecallantide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ecallantide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ecallantide in pediatric patients.

Contraindications

• Condition1

Warnings

ANAPHYLAXIS: See full prescribing information for complete Boxed Warning. ANAPHYLAXIS: Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ecallantide in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ecallantide in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ecallantide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ecallantide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ecallantide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ecallantide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ecallantide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ecallantide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ecallantide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ecallantide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ecallantide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ecallantide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ecallantide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Subcutaneous

Administration Instructions KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.

KALBITOR should be refrigerated and protected from the light. KALBITOR is a clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.

Using aseptic technique, withdraw 1 mL (10 mg) of KALBITOR from the vial using a large bore needle. Change the needle on the syringe to a needle suitable for subcutaneous injection. The recommended needle size is 27 gauge. Inject KALBITOR into the skin of the abdomen, thigh, or upper arm. Repeat the procedure for each of the 3 vials comprising the KALBITOR dose. The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm). There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.

The same instructions apply to an additional dose administered within 24 hours. Different injection sites or the same anatomical location (as used for the first administration) may be used.

Monitoring

There is limited information regarding Monitoring of Ecallantide in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Ecallantide in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ecallantide in the drug label.

Pharmacology

There is limited information regarding Ecallantide Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ecallantide01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ecallantide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ecallantide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ecallantide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ecallantide in the drug label.

How Supplied

Storage

There is limited information regarding Ecallantide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ecallantide in the drug label.

Precautions with Alcohol

• Alcohol-Ecallantide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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