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 INFORMATION
    These highlights do not include all the information needed to use KALBITOR® safely and effectively. See full prescribing information for KALBITOR. KALBITOR (ecallantide) injection, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    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 USAGE
    KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 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 ...
  • 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.
  • 4 CONTRAINDICATIONS
    Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. [see Warnings and Precautions (5.1)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions, Including Anaphylaxis - Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE ...
  • 6 ADVERSE REACTIONS
    Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [see Contraindications (4) and Warnings and Precautions (5.1)]. 6.1 Clinical Trials ...
  • 7 DRUG INTERACTIONS
    No formal drug interactions studies were performed. No in vitro metabolism studies were performed.
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 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 ...
  • 10 OVERDOSAGE
    There 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.
  • 11 DESCRIPTION
    KALBITOR (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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    The 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    KALBITOR (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 ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Medication Guide) Advise patients that KALBITOR may cause anaphylaxis and other hypersensitivity reactions. Advise patients that KALBITOR should be ...
  • SPL UNCLASSIFIED SECTION
    Manufactured 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 ...
  • Medication Guide
    KALBITOR® (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 ...
  • PRINCIPAL DISPLAY PANEL - 10 mg/mL Vial Carton
    ATTENTION: 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information