Label: ACTHREL- corticorelin ovine triflutate injection, powder, lyophilized, for solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated November 12, 2021

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  • SPL UNCLASSIFIED SECTION
    For intravenous injection only - DIAGNOSTIC USE ONLY
  • DESCRIPTION
    ACTHREL® (corticorelin ovine triflutate for injection) is a sterile, nonpyrogenic, lyophilized white cake powder, containing corticorelin ovine triflutate, a trifluoroacetate salt of a synthetic ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - In normal subjects, intravenous administration of corticorelin results in a rapid and sustained increase of plasma ACTH levels and a near parallel increase of plasma cortisol ...
  • INDICATIONS AND USAGE
    ACTHREL® is indicated for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. Differential Diagnosis - There are two forms of ...
  • CONTRAINDICATIONS
    ACTHREL is contraindicated in patients with a history of a hypersensitivity reaction to ovine corticorelin or any of its excipients.
  • PRECAUTIONS
    General - The severity of adverse effects to a corticorelin injection appear to be dose-dependent. Dosages above 1 mcg/kg are not recommended. While few adverse effects have been observed at the ...
  • ADVERSE REACTIONS
    Hypersensitivity reactions have been reported with 1 mcg/kg or 100 mcg/patient and include flushing of the face, neck, and upper chest; dyspnea, wheezing, urticaria, and angioedema (involving ...
  • OVERDOSAGE
    Symptoms of overdose include severe facial flushing, cardiovascular changes, and dyspnea. In the event of toxic overdose (see ADVERSE REACTIONS), adverse effects should be treated ...
  • DOSAGE AND ADMINISTRATION
    Dosage - A single intravenous dose of ACTHREL® at 1 mcg/kg is recommended for the testing of pituitary corticotrophin function. A dose of 1 mcg/kg is the lowest dose that produces maximal ...
  • HOW SUPPLIED
    ACTHREL® is supplied as a sterile, nonpyrogenic, lyophilized, white cake containing 100 mcg corticorelin ovine (as the trifluoroacetate), 0.88 mg ascorbic acid, 10 mg lactose, and 26 mg cysteine ...
  • SPL UNCLASSIFIED SECTION
    MANUFACTURED FOR: FERRING PHARMACEUTICALS INC. PARSIPPANY, NJ 07054 - Origin Germany - Rx only - Rev. 09/2018 - XXXXXXXXXX
  • PRINCIPAL DISPLAY PANEL - 100 mcg Vial Label
    100 mcg - ACTHREL® (corticorelin ovine triflutate for injection) NDC 55566-0302-1 - Contains 100 mcg corticorelin ovine (as the trifluoroacetate), 10 mg lactose, 0.88 mg ascorbic acid, and 26 ...
  • INGREDIENTS AND APPEARANCE
    Product Information