Corticorelin

What is Corticorelin?

• Corticorelin (Acthrel; Xerecept) a synthetic peptide that is used for the determination of pituitary corticotrophic responsiveness.
• Corticorelin ovine has an amino acid sequence identical to ovine corticotropin-releasing hormone (oCRH). Corticorelin ovine is an analogue of the naturally occurring human CRH (hCRH) peptide.
• Both peptides are potent stimulators of adrenocorticotropic hormone (ACTH) release from the anterior pituitary. ACTH stimulates cortisol production from the adrenal cortex.

Corticorelin

What are the uses of this medicine?

• Corticorelin (Acthrel; Xerecept) is used for differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome.

Differential Diagnosis: There are two forms of Cushing's syndrome:

• ACTH-dependent in which hypercortisolism is due either to pituitary hypersecretion of ACTH.
• ACTH- independent in which hypercortisolism is due to autonomous cortisol secretion by an adrenal tumor.

The corticorelin test is used to aid in establishing the source of excessive ACTH secretion.

How does this medicine work?

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 that is used for the determination of pituitary corticotrophic responsiveness. Corticorelin ovine has an amino acid sequence identical to ovine corticotropin-releasing hormone (oCRH). Corticorelin ovine is an analogue of the naturally occurring human CRH (hCRH) peptide. Both peptides are potent stimulators of adrenocorticotropic hormone (ACTH) release from the anterior pituitary. ACTH stimulates cortisol production from the adrenal cortex.

The corticorelin stimulation test helps to differentiate between the etiologies of ACTH-dependent hypercortisolism as follows:

• High basal plasma ACTH plus high basal plasma cortisol (20 - 40 mcg/dL). Acthrel® injection (1 mcg/kg) results in:
• Increased plasma ACTH levels
• Increased plasma cortisol levels
• Diagnosis: Cushing's disease (ACTH of pituitary origin)

High basal plasma ACTH (may be very high) plus high basal plasma cortisol (20 - 40 mcg/dL). Acthrel® injection (1 mcg/kg) results in:

• Little or no response of plasma ACTH levels
• Little or no response of plasma cortisol levels
• Diagnosis: Ectopic ACTH syndrome

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of a hypersensitivity reaction to ovine corticorelin or any of its excipients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• dexamethasone
• heparin

Is this medicine FDA approved?

• Corticorelin ovine triflutate is designated as an orphan drug by the US FDA on 11/24/1989, used in For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome, manufactured / distributed by Ferring Laboratories, Inc.

How should this medicine be used?

Recommended dosage:

• A single intravenous dose of Acthrel® at 1 mcg/kg is recommended for the testing of pituitary corticotrophin function.

Administration:

• The preparation is intended for intravenous administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Acthrel® for injection is available in vials containing 100 mcg corticorelin ovine

This medicine is available in fallowing brand namesː

• Acthrel

What side effects can this medication cause?

The most common side effects of this medicine include:

• dyspnea
• wheezing
• urticaria
• angioedema
• flushing
• tachycardia
• hypotension
• dyspnea
• "chest compression" or tightness

What special precautions should I follow?

• 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 mcg dose, higher doses have been associated with transient tachycardia, decreased blood pressure, loss of consciousness, and asystole.
• Hypersensitivity reactions have been reported in patients receiving Acthrel. Discontinue Acthrel, monitor and treat if indicated.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe facial flushing
• cardiovascular changes
• dyspnea

Management of overdosage:

• In the event of toxic overdose, adverse effects should be treated symptomatically.

Can this medicine be used in pregnancy?

• It is also not known whether corticorelin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Acthrel should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Only a few tests have been performed on children.
• Dosages were 1 mcg/kg body weight.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• CORTICORELIN OVINE TRIFLUTATE

Inactive ingredient:

• ASCORBIC ACID
• LACTOSE, UNSPECIFIED FORM
• CYSTEINE HYDROCHLORIDE

Who manufactures and distributes this medicine?

Manufactured for:

• Ferring Pharmaceuticals Inc.
• Parsippany, NJ

What should I know about storage and disposal of this medication?

• Acthrel is stable in the lyophilized form when stored refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light.
• The reconstituted solution is stable up to 8 hours under refrigerated conditions.
• Discard unused reconstituted solution.

• Dailymed label info on Corticorelin
• FDA Corticorelin