Generic drug: corticorelin ovine triflutate

Brand name: Acthrel

What is Acthrel (corticorelin ovine triflutate), and how does it work?

Acthrel (corticorelin ovine triflutate) for Injection is a man-made form of a hormone that occurs naturally in the body and is used as part of a medical test in people with Cushing's syndrome, an endocrine disorder caused by high levels of cortisol (a steroid hormone produced by the adrenal gland). Acthrel is also used to help your doctor determine why your body is producing too much of its own cortisol.

DIAGNOSTIC USE ONLY

What are the side effects of Acthrel?

Common side effects of Acthrel include:

  • warmth,
  • redness, or
  • tingly feeling in your face, neck, or chest

Side effects with higher doses of Acthrel include fast heart rate, low blood pressure (hypotension), shortness of breath, and tightness in the chest.

What is the dosage for Acthrel?

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 and significant (though apparently sub-maximal) ACTH responses. Doses above 1 mcg/kg are not recommended.
  • At a dose of 1 mcg/kg, the ACTH and cortisol responses to Acthrel are prolonged and remain elevated for up to 2 hours.
  • The maximum increment in plasma ACTH occurs between 15 and 60 minutes after Acthreladministration, whereas the maximum increment in plasma cortisol occurs between 30 and 120 minutes. In a clinical study of 30 normal healthy men, the peak plasma ACTH and cortisol responses to Acthrel administration in the early afternoon occurred at 42 ± 29 minutes and 65 ± 26 minutes (average ±SD), respectively.
  • If a repeated evaluation using the corticorelin stimulation test with Acthrel is needed, it is recommended that the repeat test be carried out at the same time of day as the original test because there are differences in basal levels and peak response levels following a.m. or p.m. administration to normal humans.

Administration

  • Acthrel is to be reconstituted aseptically with 2 mL of Sodium Chloride injection, USP (0.9% sodium chloride), at the time of use by injecting 2 mL of the saline diluent into the lyophilized drug product cake.
  • To avoid bubble formation, DO NOT SHAKE the vial; instead, roll the vial to dissolve the product.
  • The sterile solution containing 50 mcg corticorelin/mL is then ready for injection by the intravenous route.
  • The dosage to be administered is determined by the patient's weight (1 mcg corticorelin/kg).
  • Some of the adverse effects can be reduced by administering the drug as an infusion over 30 seconds instead of as a bolus injection.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What drugs interact with Acthrel?

  • 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 test is not recommended.
  • A possible interaction between corticorelin and heparin may have been responsible for a major hypotensive reaction that occurred after corticorelin administration.

Is Acthrel safe to use while pregnant or breastfeeding?

  • 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.
  • 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.

Summary

Acthrel (corticorelin ovine triflutate) for Injection is a man-made form of a hormone that occurs naturally in the body and is used as part of a medical test in people with Cushing's syndrome, an endocrine disorder caused by high levels of cortisol (a steroid hormone produced by the adrenal gland). Acthrel is also used to help your doctor determine why your body is producing too much of its own cortisol. Common side effects of Acthrel include warmth, redness, or tingly feeling in your face, neck, or chest.

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Medically Reviewed on 3/12/2021
References
All sections courtesy of the U.S. Food and Drug Administration