Acthrel

Name: Acthrel

What should I discuss with my health care provider before receiving Acthrel (corticorelin ovine triflutate)?

Before you receive this medicine, tell your doctor about all your medical conditions and allergies.

FDA pregnancy category C. It is not known whether corticorelin ovine triflutate will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether corticorelin ovine triflutate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What happens if I miss a dose?

Since corticorelin ovine triflutate is used as a single dose, it does not have a daily dosing schedule.

What other drugs will affect Acthrel (corticorelin ovine triflutate)?

Other drugs may interact with corticorelin ovine triflutate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Proper Use of Acthrel

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using Acthrel

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Allergic reactions may occur while you are receiving this medicine. Tell your doctor right away if you have a rash or itching skin, flushing or redness of the face, neck, and upper chest, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs, or trouble breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What are some things I need to know or do while I take Acthrel?

  • Tell all of your health care providers that you take Acthrel. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Acthrel 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 monohydrate. Trace amounts of chloride ion may be present from the manufacturing process. The package provides a single-dose, rubber-capped, 5 mL, brown-glass vial (NDC 55566-0302-1) containing 100 mcg corticorelin ovine (as the trifluoroacetate). 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.

MANUFACTURED FOR:

FERRING PHARMACEUTICALS INC.
PARSIPPANY, NJ 07054

Origin Germany

Rx only

Rev. 07/2016
2009054586

For Healthcare Professionals

Applies to corticorelin: intravenous powder for injection

Cardiovascular

Very common (10% or more): Flushing of the face, neck, and upper chest (16%)
Common (1% to 10%): Asystole
Frequency not reported: Prolonged flushing, tachycardia, hypotension, "chest compression" or tightness, increases in heart rate, decreases in blood pressure, transient flushing[Ref]

General

The most commonly reported side effects were flushing of the face, neck, and upper chest.[Ref]

Nervous system

Common (1% to 10%): "Absence-like" loss of consciousness, grand mal epileptic seizure[Ref]

Respiratory

Common (1% to 10%): Urge to take a deep breath
Frequency not reported: Dyspnea[Ref]

Some side effects of Acthrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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