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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.
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.