Product image of Mifegyne (Mifepristone) supplied by GNH India

Mifegyne

Active Ingredient:
Mifepristone
Origin:
EU

Mifegyne (Mifepristone)

Mifepristone, the active ingredient in Mifegyne, is a progesterone receptor antagonist presented as a 200 mg oral tablet for oral use. It is employed in the medical termination of pregnancy up to 10 weeks gestation, in the management of Cushing’s syndrome, and as an adjunct in the treatment of uterine fibroids, providing a non‑surgical therapeutic option for eligible patients.

GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and regulatory requirements.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

  • Mifepristone acts as a progesterone receptor antagonist and is indicated for several reproductive and endocrine conditions.
  • Medical termination of intrauterine pregnancy (≤10 weeks): induces uterine decidual breakdown and expulsion of the gestational sac.
  • Cushing's syndrome management: blocks peripheral glucocorticoid receptors, reducing cortisol‑mediated effects.
  • Uterine fibroid treatment: decreases fibroid size and associated bleeding by antagonizing progesterone‑driven growth.

How It Works

  • Mifepristone competitively binds to progesterone receptors, preventing progesterone‑mediated maintenance of the endometrium and decidua, leading to decidual breakdown and detachment of the gestational sac. It also antagonizes glucocorticoid receptors, diminishing cortisol activity, which contributes to its efficacy in Cushing's syndrome and fibroid reduction.

Side Effects

Common Side Effects

  • Nausea or vomiting.
  • Abdominal cramping or pelvic pain.
  • Vaginal bleeding or spotting.
  • Fatigue or headache.
  • Diarrhea.
  • Dizziness.

Serious or Rare Side Effects

  • Severe hemorrhage requiring medical intervention.
  • Infection or sepsis after incomplete evacuation.
  • Allergic reactions including rash, angioedema, or anaphylaxis.
  • Liver enzyme elevation or hepatic dysfunction.
  • Uterine rupture (rare).
  • Persistent gestational tissue leading to prolonged bleeding.

Precautions & Warnings

  • Mifepristone should be used only after confirming eligibility and gestational age.
  • Confirm gestational age: ensure pregnancy is ≤10 weeks before administration.
  • Assess contraindications: exclude ectopic pregnancy, chronic adrenal insufficiency, anticoagulant therapy, or severe anemia.
  • Monitor for infection: watch for fever, foul discharge, or abdominal tenderness.
  • Ensure follow‑up: schedule ultrasound to verify complete uterine evacuation.
  • Avoid use in breastfeeding: contraindicated due to potential fetal exposure.
  • Store at ambient temperature (below 25 °C): keep in the original pack, protect from moisture and light.

Avoid Interactions

Mifepristone may interact with several drug classes.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased risk of severe bleeding.
  • Systemic corticosteroids: may diminish efficacy in Cushing's syndrome.
  • Rifampin: induces hepatic enzymes, reducing mifepristone plasma levels.

Moderate Interactions (Monitor Closely)

  • Antifungal agents (e.g., ketoconazole): may raise mifepristone concentrations.
  • Anticonvulsants (e.g., phenytoin): may alter drug metabolism.
  • NSAIDs: may exacerbate gastrointestinal discomfort.

Frequently Asked Questions

Mifegyne contains mifepristone, a progesterone receptor antagonist used for the medical termination of intrauterine pregnancy up to 10 weeks, for managing Cushing’s syndrome, and as an adjunct in treating uterine fibroids.

Mifepristone competitively blocks progesterone receptors, causing breakdown of the uterine lining and detachment of the gestational sac. It also antagonizes glucocorticoid receptors, reducing cortisol activity, which underlies its use in Cushing’s syndrome and fibroid reduction.

The prescribed dose of Mifegyne is determined by a qualified healthcare professional based on the specific indication, gestational age, and patient factors. Only a prescriber can set the appropriate regimen.

Mifegyne is contraindicated in pregnancy beyond the approved termination window and is classified as pregnancy category X. It is also contraindicated during breastfeeding because it may pass into breast milk and affect the infant.

To order Mifegyne, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Mifegyne (mifepristone) is a progesterone receptor antagonist, whereas other abortifacients such as misoprostol act as prostaglandin analogues. Mifepristone is typically used first to prime the uterus, followed by misoprostol to complete expulsion, offering a two‑step regimen with high efficacy.

Mifegyne tablets should be stored at ambient temperature below 25 °C, in the original packaging, protected from moisture and light to maintain stability and potency.

Mifegyne is taken orally as a single tablet under medical supervision. For termination of pregnancy, it is usually followed by a prostaglandin analogue taken 24–48 hours later, as directed by the prescriber.

Serious risks include severe uterine hemorrhage, infection or sepsis after incomplete evacuation, allergic reactions such as anaphylaxis, and rare events like uterine rupture. Prompt medical attention is essential if any of these occur.

Mifegyne should not be used in patients with ectopic pregnancy, chronic adrenal insufficiency, severe anemia, anticoagulant therapy, known hypersensitivity to mifepristone, or in women who are breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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