About Metopirone®

What is Metopirone®?

Each soft capsule of Metopirone® contains 250 mg of metyrapone.1

Indication:1

Metopirone® is a diagnostic drug for testing hypothalamic-pituitary ACTH function. The metyrapone diagnostic test should be restricted to referral hospital centers.

Overnight single‑dose
Metopirone® test (OMT)

Multiple‑dose
6-day treatment plan Metopirone® test

Where


Outpatient*

Hospitalization required

Adult dosage

30 mg/kg at midnight (maximum 3 g) with yogurt or milk


750 mg orally, every 4 hours for 6 doses (total dose of 4.5 g) with milk or snack

Pediatric dosage

30 mg/kg at midnight (maximum 3 g) with yogurt or milk


Take 15 mg/kg orally (minimum 250 mg) every 4 hours for 6 doses with milk or snack

Labs


1 blood sample: Plasma 11-DOC and/or ACTH levels


Samples: 24-hrs urinary 17-OHCS and/or 17-KGS levels. Urine testing done Day 1, 2, and 6. Measure ATCH levels on Day 2.

When to measure


Early in the following morning
(7:30 - 8:00 am)


Day 1 and 2 (before Metopirone® administration) and Day 6 (after Metopirone® administration)

Figure prepared by HRA Pharma based on Metopirone US Prescribing Information.

* Patients with suspected adrenocortical insufficiency should be hospitalized overnight as a precautionary measure.

Abbreviations:
ACTH: Adrenocorticotropic hormone; 11-DOC: 11-deoxycortisol; 17–OHCS: 17-hydroxycorticosteroids; 17–KGS: 17 ketogenic steroids.

Method of administration:1

The capsules should be taken with a snack, yogurt or milk.

Mode of action:1,2

Metopirone® is an inhibitor of endogenous adrenal corticosteroid synthesis.
It reduces cortisol and corticosterone production by inhibiting the 11 β – hydroxylation reaction in the adrenal cortex.

As a consequence: compensatory rise in ACTH and increase in:

  • 11-deoxycortisol (S compound) and ACTH levels in plasma (OMT)
  • 17-OHCS and 17-KGS levels in urine (STD)

Figure prepared by HRA Pharma based on Metopirone US Prescribing Information.

REFERENCES

1. Metopirone®US Prescribing Information, February 2020
2. Avgerinos PC, Yanovski JA, Oldfield EH, Nieman LK, Cutler GB Jr. The metyrapone and dexamethasone suppression tests for the differential diagnosis of the adrenocorticotropin-dependent Cushing syndrome: a comparison. Ann Intern Med. 1994;121(5):318-327. doi:10.7326/0003-4819-121-5-199409010-00002

INDICATION AND IMPORTANT SAFETY INFORMATION

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What is Metopirone®?

METOPIRONE is used to test a patient for hypothalamic-pituitary ACTH function. The hypothalamic-pituitary ACTH is your body’s "stress system". It controls levels of cortisol and other important related hormones.

Important Safety Information you should know about METOPIRONE®

What is the most important information I should know about METOPIRONE®?

METOPIRONE may cause adrenal insufficiency.

Do not use METOPIRONE if you have adrenal cortical insufficiency or are allergic to METOPIRONE or to any of its ingredients.

Adrenal insufficiency is when the adrenal glands do not produce enough hormones. Contact your doctor if you have any of the following symptoms: anxiety, stomach pain, nausea, vomiting, diarrhea and confusion.

METOPIRONE may cause some patients to become dizzy, drowsy, or less alert then normal. Do not drive or do anything dangerous if you are dizzy or not alert while taking this medication.

What should I tell my doctor before taking METOPIRONE®?

You are taking the following medications:
Steroids (hydrocortisone)
Acetaminophen (Tylenol)
Estrogen
Phenytoin

Are pregnant or plan to become pregnant. METOPIRONE should be given to a pregnant woman only if clearly needed.

Are breastfeeding or plan to breastfeed.

What are the most common side effects of METOPIRONE®?

The most common side effects of METOPIRONE include:
Nausea (upset stomach) and vomiting
Diarrhea
Sedation
Dizziness
Stomach discomfort or pain
Rash
Hypotension (low blood pressure)
Headache

These are not all of the possible side effects of METOPIRONE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-855-M-Pirone (1-855-674-7663) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, for METOPIRONE® (metyrapone), capsules.

HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, Chatillon, FRANCE
Tel: +33 (0) 1 40 33 11 30 / Fax: +33 (0) 1 40 33 12 31
© 2020 HRA Pharma Rare Diseases | Metopirone is a registered trademark of HRA Pharma Rare Diseases
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Last updated: October 2020; MTP – US – 0002

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