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 an oral tablet for systemic use. It is employed for the medical termination of intra‑uterine pregnancy up to ten weeks and, off‑label, for managing Cushing’s syndrome.

GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, offering batch‑tested, WHO‑GMP‑aligned product with full documentation, reliable logistics and regulatory support, ensuring consistent potency and safety across markets for global authorized medical use.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

Mifegyne (mifepristone) acts as a progesterone receptor antagonist and is used in specific reproductive and endocrine indications.

  • Medical termination of intrauterine pregnancy (≤10 weeks): induces decidual breakdown, detaches the gestational sac and prepares the uterus for prostaglandin‑mediated expulsion.
  • Cushing's syndrome (off‑label): blocks progesterone receptors that modulate adrenal steroidogenesis, leading to decreased cortisol secretion in selected patients.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the uterus, placenta and hypothalamic‑pituitary axis, preventing progesterone from stabilising the endometrium. This antagonism triggers decidual degeneration, detaches the embryo, and sensitises uterine smooth muscle to prostaglandins, facilitating expulsion. In endocrine tissue, receptor blockade can diminish adrenal cortisol synthesis, accounting for its off‑label use in Cushing’s syndrome.

Side Effects

Mifegyne may cause a range of adverse reactions, which are categorised by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Vaginal bleeding: irregular or prolonged spotting.
  • Abdominal cramping: uterine pain or discomfort.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Severe infection: signs of sepsis after incomplete abortion.
  • Heavy hemorrhage: rapid blood loss requiring medical intervention.
  • Allergic reaction: rash, swelling, or anaphylaxis.

Precautions & Warnings

Before prescribing Mifegyne, clinicians should evaluate the following safety considerations.

  • Contraindication: confirmed or suspected ectopic pregnancy.
  • Contraindication: chronic adrenal insufficiency or uncontrolled hypertension.
  • Caution: use only within ten weeks gestation confirmed by ultrasound.
  • Monitoring: ensure availability of surgical or medical backup for incomplete abortion.
  • Patient counseling: inform about expected bleeding and need for follow‑up.
  • Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.

Avoid Interactions

Mifegyne can interact with other medicines that affect hormonal pathways or hemostasis.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce mifepristone exposure.
  • Anticoagulants (warfarin, direct oral anticoagulants): increased risk of bleeding.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (ketoconazole, fluconazole): may increase mifepristone levels.
  • Hormonal contraceptives: reduced effectiveness when used concurrently.
  • NSAIDs: may mask abdominal pain, requiring careful assessment.

Frequently Asked Questions

Mifegyne contains mifepristone and is indicated for the medical termination of intra‑uterine pregnancy up to ten weeks gestation. It is also used off‑label in selected cases of Cushing’s syndrome to help lower cortisol production.

Mifepristone acts as a competitive antagonist at progesterone receptors. By blocking progesterone’s action, it causes the uterine lining to break down and the embryo to detach, while also sensitising the uterus to prostaglandins that promote expulsion. In adrenal tissue, the same blockade can reduce cortisol synthesis.

The specific dose and regimen of Mifegyne are determined by the prescribing clinician based on the indication, gestational age and local medical guidelines. Patients should follow the exact instructions provided by their qualified health‑care professional.

Mifegyne is contraindicated in pregnancy beyond the intended medical termination and should not be used during ongoing pregnancy. It is also not recommended for breastfeeding mothers because the drug can be excreted in breast milk and may affect the infant.

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

The most common partner drug is misoprostol, a prostaglandin analogue. Mifegyne initiates uterine lining breakdown, while misoprostol induces uterine contractions to complete expulsion. Together they provide a highly effective regimen, whereas misoprostol alone is less effective for early medical abortion.

Mifegyne tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture and light. Keep the product out of reach of children and avoid exposure to extreme heat or humidity.

Mifegyne is supplied as an oral tablet and is taken by mouth under medical supervision. The tablet is usually administered in a clinical setting after confirming gestational age and eligibility, followed by a scheduled follow‑up to assess the outcome.

Serious adverse events include heavy hemorrhage, severe infection that may lead to sepsis, and allergic reactions such as rash, swelling or anaphylaxis. Patients should seek immediate medical attention if they experience excessive bleeding, fever, severe abdominal pain or signs of an allergic response.

Mifegyne should not be used by individuals with a confirmed or suspected ectopic pregnancy, chronic adrenal insufficiency, uncontrolled hypertension, or known hypersensitivity to mifepristone. It is also contraindicated beyond ten weeks gestation and in patients who are unable to undergo appropriate medical follow‑up.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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