ACTHREL Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Ferring Pharmaceuticals Inc.

Λέξεις κλειδιά

55566-0302

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1. 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 peptide ...

2. 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. In addition, ...

3. Indications and Usage

ACTHREL is indicated for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome. Differential Diagnosis There are two forms of Cushings syndrome: ...

4. Contraindications

ACTHREL is contraindicated in patients with a history of a hypersensitivity reaction to ovine corticorelin or any of its excipients.

6. Precautions

Hypersensitivity Hypersensitivity reactions have been reported in patients receiving ACTHREL. Reactions included urticaria, flushing of the face, neck and upper chest; dyspnea, wheezing, urticaria and ...

6.1. 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 1 mcg/kg or 100 ...

6.4. Drug Interactions

The plasma ACTH response to corticorelin injection is inhibited or blunted in normal subjects pretreated with dexamethasone. The use of a heparin solution to maintain i.v. cannula patency during the corticorelin ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been conducted with corticorelin to evaluate carcinogenic potential, mutagenicity, or effect on fertility.

6.7. Pregnancy

Animal reproduction studies have not been conducted with corticorelin. It is also not known whether corticorelin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ...

6.9. Nursing Mothers

It is not known whether corticorelin is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACTHREL is administered to a nursing woman.

6.10. Pediatric Use

Only a few tests have been performed on children. Dosages were 1 mcg/kg body weight. Patient studies have involved only children with multiple hypothalamic and/or pituitary hormone deficiencies, or tumors. ...

7. 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 tongue, lip ...

9. 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 symptomatically.

10. 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 cortisol responses ...

11. 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 hydrochloride ...