Label: KALBITOR- ecallantide injection, solution
- NDC Code(s): 47783-101-01
- Packager: Takeda Pharmaceuticals America, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated December 15, 2023
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use KALBITOR® safely and effectively. See full prescribing information for KALBITOR. KALBITOR (ecallantide) injection, for ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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. [see Contraindications (4), Warnings and Precautions (5.1), and Adverse Reactions (6)]
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1 INDICATIONS AND USAGEKALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
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2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing - 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 ...
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3 DOSAGE FORMS AND STRENGTHSKALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.
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4 CONTRAINDICATIONSDo not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. [see Warnings and Precautions (5.1)].
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5 WARNINGS AND PRECAUTIONS5.1 Hypersensitivity Reactions, Including Anaphylaxis - Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE ...
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6 ADVERSE REACTIONSHypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [see Contraindications (4) and Warnings and Precautions (5.1)]. 6.1 Clinical Trials ...
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7 DRUG INTERACTIONSNo formal drug interactions studies were performed. No in vitro metabolism studies were performed.
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - The available data from the pharmacovigilance database for Kalbitor have not identified a drug-associated risk of major birth defects, miscarriage or adverse ...
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10 OVERDOSAGEThere have been no reports of overdose with KALBITOR. HAE patients have received single doses up to 90 mg intravenously without evidence of dose-related toxicity.
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11 DESCRIPTIONKALBITOR (ecallantide) is a human plasma kallikrein inhibitor for injection for subcutaneous use. Ecallantide is a 60-amino-acid protein produced in Pichia pastoris yeast cells by recombinant DNA ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q and inherited as an autosomal ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - A two-year study was conducted in rats to assess the carcinogenic potential of KALBITOR. No evidence of tumorigenicity was observed in ...
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14 CLINICAL STUDIESThe safety and efficacy of KALBITOR to treat acute attacks of hereditary angioedema in adolescents and adults were evaluated in 2 randomized, double-blind, placebo-controlled trials (EDEMA4 and ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGKALBITOR (ecallantide) is supplied as three 10 mg/mL single-use vials packaged in a carton. Each vial contains 10 mg of ecallantide. Each vial contains a slight overfill. NDC (47783-101-01): 3 ...
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17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Medication Guide) Advise patients that KALBITOR may cause anaphylaxis and other hypersensitivity reactions. Advise patients that KALBITOR should be ...
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SPL UNCLASSIFIED SECTIONManufactured by: Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA 02421 - U.S. License No. 1898 - KALBITOR® is a registered trademark of Dyax Corp., a Takeda company. TAKEDA® and the TAKEDA Logo® are ...
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Medication GuideKALBITOR® (KAL-bi-tor) (ecallantide) Read this Medication Guide before you start receiving KALBITOR and before each treatment. There may be new information. This Medication Guide does not take ...
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PRINCIPAL DISPLAY PANEL - 10 mg/mL Vial CartonATTENTION: Dispense the enclosed - Medication Guide to each patient. NDC# 47783-101-01 - KALBITOR® ecallantide - 10 mg/mL - Injection - For Subcutaneous Use Only - Single Use; Discard Unused ...
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INGREDIENTS AND APPEARANCEProduct Information