Acthrel

DRUG 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 that is used for the determination of pituitary corticotroph 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 structural formula for corticorelin ovine triflutate is described below:

Ser-Gln-Glu-Pro-Pro-Ile-Ser-Leu-Asp-Leu-Thr-Phe-His-Leu-Leu-Arg-Glu-Val-Leu-Glu-Met-Thr-Lys-
Ala-Asp-Gln-Leu-Ala-Gln-Gln-Ala-His-Ser-Asn-Arg-Lys-Leu-Leu-Asp-Ile-Ala-NH2XCF3COOH

whereas X=4 - 8.

The empirical formula of corticorelin ovine is C205H339N59O63S with a molecular weight of 4670.35 Daltons.

ACTHREL® (corticorelin ovine triflutate for injection) for injection is available in vials containing 100 mcg corticorelin ovine (as the trifluoroacetate), 0.88 mg ascorbic acid, 10 mg lactose, and 26 mg cysteine hydrochloride monohydrate. Trace amounts of chloride ion may be present from the manufacturing process. The preparation is intended for intravenous administration.

What are the possible side effects of corticorelin ovine trifluate (Acthrel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you feel like you might pass out, or if you have:

  • a fast heart rate;
  • a tight feeling in your chest; or
  • if you feel like you need to take deep breaths.

Less serious side effects may include warmth, redness, or tingly feeling in your face, neck, or chest.

This is not a...

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Acthrel Patient Information Including Side Effects

Brand Names: Acthrel

Generic Name: corticorelin ovine triflutate (Pronunciation: KOR ti koe REL in OH vine TRYE floo ate)

  • What is corticorelin ovine trifluate (Acthrel)?
  • What are the possible side effects of corticorelin ovine trifluate (Acthrel)?
  • What is the most important information I should know about corticorelin ovine trifluate (Acthrel)?
  • What should I discuss with my health care provider before receiving corticorelin ovine trifluate (Acthrel)?
  • How is corticorelin ovine trifluate given (Acthrel)?
  • What happens if I miss a dose (Acthrel)?
  • What happens if I overdose (Acthrel)?
  • What should I avoid after receiving corticorelin ovine trifluate (Acthrel)?
  • What other drugs will affect corticorelin ovine trifluate (Acthrel)?
  • Where can I get more information?

What is corticorelin ovine trifluate (Acthrel)?

Corticorelin ovine trifluate is a man-made form of a hormone that occurs naturally in the body.

Corticorelin ovine trifluate is used as part of a medical test in people with Cushing's syndrome. Cushing syndrome is an endocrine disorder caused by high levels of cortisol (a steroid hormone produced by the adrenal gland).

This medication is also used to help your doctor determine why your body is producing too much of its own cortisol.

Corticorelin ovine trifluate may also be used for purposes not listed in this medication guide.

What are the possible side effects of corticorelin ovine trifluate (Acthrel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you feel like you might pass out, or if you have:

  • a fast heart rate;
  • a tight feeling in your chest; or
  • if you feel like you need to take deep breaths.

Less serious side effects may include warmth, redness, or tingly feeling in your face, neck, or chest.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about corticorelin ovine trifluate (Acthrel)?

Tell your doctor about any allergies or medical conditions you have.

Tell your doctor if you have recently used dexamethasone (Decadron, Dexone, Hexadrol). Dexamethasone can affect the results of your corticorelin test.

During the corticorelin test, your caregivers will need to draw at least 5 blood samples from you. This will help your doctor determine more about your condition.

The timing of your blood tests before and after the injection is important in assuring the most accurate results from a corticorelin test. Plan to stay in the care of your healthcare providers for at least 1 hour after your injection.

Tell your caregivers at once if you feel like you might pass out, or if you have a fast heart rate, a tight feeling in your chest, or if you feel like you need to take deep breaths.

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