Label: ACTHAR- repository corticotropin injection
ACTHAR- repository corticotropin injection

  • NDC Code(s): 63004-8710-1, 63004-8710-2, 63004-8711-1, 63004-8711-4, view more
  • Packager: Mallinckrodt ARD LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ACTHAR® GEL safely and effectively. See full prescribing information for ACTHAR GEL. ACTHAR GEL (repository corticotropin ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Infantile Spasms - Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. 1.2 Multiple Sclerosis - Acthar Gel is ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Information - Acthar Gel vial is intended for either intramuscular or subcutaneous injection. Acthar Gel single-dose pre-filled SelfJect injector is for subcutaneous ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection available as: 400 USP Units/5 mL (80 USP Units/mL) in a multi-dose vial for subcutaneous or intramuscular injection. 40 USP Units/0.5 mL in a single-dose pre-filled SelfJect injector for ...
  • 4 CONTRAINDICATIONS
    Acthar Gel is contraindicated: for intravenous administration. in infants under 2 years of age who have suspected congenital infections. with concomitant administration of live or live attenuated ...
  • 5 WARNINGS AND PRECAUTIONS
    The adverse effects of Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with Acthar Gel, but they might ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Cushing's Syndrome and Adrenal Insufficiency Upon ...
  • 7 DRUG INTERACTIONS
    Formal drug-drug interaction studies have not been performed. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on Acthar Gel's pharmacological effect of stimulating an endogenous steroid response [see Clinical Pharmacology ( 12.1)], Acthar Gel may cause fetal harm ...
  • 11 DESCRIPTION
    Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process converts the initial porcine pituitary ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of Acthar Gel in the treatment of infantile spasms is unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Adequate studies of the carcinogenic potential of Acthar Gel have not been conducted. Mutagenesis - The ...
  • 14 CLINICAL STUDIES
    The effectiveness of Acthar Gel as a treatment for infantile spasms was demonstrated in a single blinded (video EEG interpreter blinded) clinical trial in which patients were randomized to receive ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Acthar Gel (repository corticotropin injection) is a clear light amber solution mobile at room temperature. Acthar Gel is supplied in the following ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise caretakers of patients with infantile spasms to read the FDA-approved patient labeling (Medication Guide [for infantile spasms]). Advise caretakers or patients 18 years of age or older to ...
  • SPL UNCLASSIFIED SECTION
    For a list of patents, see https://www.mallinckrodt.com/patents/ Manufactured for: Mallinckrodt ARD LLC - Bridgewater, NJ 08807 - SPC-0188 Rev 3 - Mallinckrodt™ Pharmaceuticals
  • MEDICATION GUIDE
    Acthar® Gel (AK-thar jel) (repository corticotropin injection) This Medication Guide provides information only about the use of Acthar Gel for the treatment of Infantile Spasms. If your doctor ...
  • INSTRUCTIONS FOR USE
    ACTHAR® GEL [AK-thar jel] (repository corticotropin injection) for subcutaneous use only - Single-Dose Pre-filled SelfJect™ Injector - Green Body Injector: 40 USP Units/0.5 mL of Acthar ...
  • Quick Reference Guide
    ACTHAR® GEL [AK-thar jel] (repository corticotropin injection) for subcutaneous use only - 40 USP Units/0.5 mL - Single-Dose Pre-filled SelfJect™ Injector - Before useAfter the Injection is ...
  • INSTRUCTIONS FOR USE
    ACTHAR® GEL [AK-thar jel] (repository corticotropin injection) for subcutaneous use only - Single-Dose Pre-filled SelfJect™ Injector - Purple Body Injector: 80 USP Units/mL of Acthar ...
  • Quick Reference Guide
    ACTHAR® GEL [AK-thar jel] (repository corticotropin injection) for subcutaneous use only - 80 USP Units/mL - Single-Dose Pre-filled SelfJect™ Injector - Before useAfter the Injection is ...
  • PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
    NDC 63004-8710-1 - Acthar® Gel - (repository corticotropin - injection) 400 USP units/5 mL - (80 USP units/mL) For intramuscular or - subcutaneous use. 5 mL - multiple-dose vial - Dispense the enclosed ...
  • PRINCIPAL DISPLAY PANEL - 4 x 0.5 mL Injector Carton
    NDC 63004-8712-4 - Rx Only - Acthar® Gel - (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector - 40 USP Units/0.5 mL - For Subcutaneous Injection Only - Contains: 4 x 0.5 mL ...
  • PRINCIPAL DISPLAY PANEL - 4 x 1.0 mL Injector Carton
    NDC 63004-8711-4 - Rx Only - Acthar® Gel - (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector - 80 USP Units/mL - For Subcutaneous Injection Only - Contains: 4 x 1.0 mL Single-Dose ...
  • INGREDIENTS AND APPEARANCE
    Product Information