About Metopirone®

What is Metopirone®?

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

Indication:1

Metopirone® is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients.

Single-Dose Short Test

Where


Usually given on an outpatient basis*

Adult and pediatric dosages


The recommended single dose is 30 mg/kg (maximum 3 grams of

Metopirone) administered at midnight with milk/yogurt or snack

Labs


1 blood sample**


When to measure


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

Interpretation


Approximately 8 hours after administration of Metopirone, evaluate the values of ACTH and 11- desoxycortisol. Normal values will depend on the method used to determine ACTH and 11‑desoxycortisol levels. An intact HPA axis function is generally indicated by an increase in 11‑desoxycortisol to over 70 mcg/L. 

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

*Patients with suspected adrenocortical insufficiency based on the test results previously performed should be hospitalized overnight as a precautionary measure

**After the blood sample is collected, a prophylactic dose of glucocorticoid may be considered for patients with high risk for acute adrenal insufficiency.

Method of administration:1

The capsules should be administered at midnight with milk/yogurt or snack.

Mechanism of action:1,2

Metopirone® (metyrapone capsules) is an adrenal steroid synthesis inhibitor.

The pharmacological effect of Metopirone is to reduce cortisol and corticosterone production by inhibiting the 11-beta-hydroxylation reaction in the adrenal cortex.

Metopirone is used as a diagnostic test, with urinary 17-OHCS measured as an index of pituitary ACTH responsiveness.

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

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

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

REFERENCES

1. Metopirone® US Prescribing Information
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

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

INDICATION AND IMPORTANT SAFETY INFORMATION

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What is Metopirone®?

METOPIRONE is used, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adults and pediatric patients.

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:
Anticonvulsants (such as phenytoin)
Psychotropic drugs (drugs that effect your mind, emotions, or behavior)
Hormone preparations (such as estrogen)
Steroids (hydrocortisone)
Antithyroid agents (such as Tapazole)
Cyproheptadine
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
Sedation
Stomach discomfort or pain
Hypotension (low blood pressure)
Leukopenia, anemia, thrombocytopenia (decrease in the amount of red blood cells, white blood cells or platelets in the blood)
Diarrhea
Dizziness
Rash
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 1-844-597-6373 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

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Tel: +33 (0) 1 40 33 93 14 / Fax: +33 (0) 1 40 33 30 87
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Last updated: June 2023; MTP – US – 0028

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