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 tablet for oral use. It blocks progesterone activity, enabling medical termination of early pregnancy and is also employed in the management of Cushing’s syndrome and symptomatic uterine fibroids in adult patients.

GNH India supplies Mifegyne as a licensed, GDP‑compliant product sourced from the European Union, providing reliable access to hospitals, pharmacies and clinics worldwide through its international distribution network. The company adheres to stringent quality standards and supports regulatory compliance for its clients.

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 conditions.
  • Medical termination of pregnancy (up to 9 weeks gestation): blocks progesterone receptors, leading to decidual breakdown and, when followed by misoprostol, results in uterine evacuation.
  • Cushing's syndrome: antagonizes progesterone‑mediated pathways that contribute to cortisol excess, thereby lowering serum cortisol levels in patients with endogenous hypercortisolism.
  • Uterine fibroids: inhibits progesterone‑driven fibroid growth, helping to reduce fibroid volume and control abnormal uterine bleeding in eligible women.

How It Works

  • Mifepristone selectively binds to the progesterone receptor with high affinity, preventing progesterone from activating the receptor. This antagonism disrupts the hormonal support required for maintenance of the endometrium, leading to decidual breakdown and detachment of the gestational sac. In addition, the drug modulates glucocorticoid receptors, contributing to its effect on cortisol production in Cushing’s syndrome.

Side Effects

Mifegyne may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Bleeding: vaginal spotting or heavier bleeding after administration.
  • Nausea: mild to moderate nausea.
  • Abdominal cramping: uterine cramping or pain.
  • Diarrhea: loose stools or gastrointestinal upset.

Serious or Rare Side Effects

  • Severe infection: risk of sepsis if retained products remain.
  • Excessive hemorrhage: heavy bleeding requiring medical intervention.
  • Allergic reaction: rash, urticaria, or anaphylaxis.

Precautions & Warnings

Prior to prescribing Mifegyne, clinicians should evaluate several safety considerations.

  • Gestational age assessment: confirm pregnancy is ≤9 weeks by ultrasound.
  • Contraindications: avoid in ectopic pregnancy, chronic adrenal failure, or anticoagulant therapy.
  • Cardiovascular status: monitor patients with hypertension or cardiac disease.
  • Infection risk: assess for pelvic infection before use.
  • Follow‑up care: arrange clinical review after medication to confirm complete evacuation.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.

Avoid Interactions

Mifegyne can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce mifepristone plasma levels.
  • Anticoagulants (e.g., warfarin): increased risk of bleeding when combined with mifepristone‑induced uterine bleeding.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase mifepristone exposure.
  • Glucocorticoids: may blunt the cortisol‑lowering effect in Cushing’s syndrome.
  • Misoprostol: required for complete abortion, dosing must be coordinated.

Frequently Asked Questions

Mifegyne contains mifepristone and is prescribed for the medical termination of early intrauterine pregnancy up to nine weeks gestation, for the treatment of endogenous Cushing’s syndrome, and for reducing the size and bleeding associated with symptomatic uterine fibroids in selected adult women.

Mifepristone acts as a selective progesterone receptor antagonist. By binding to the receptor it blocks progesterone‑driven signaling, causing breakdown of the decidua and detachment of the gestational sac. It also interferes with glucocorticoid receptors, helping to lower cortisol production in Cushing’s syndrome.

The exact dose and regimen of Mifegyne are determined by the prescribing clinician based on the indication, gestational age and patient factors. In most medical‑abortion protocols a single 200 mg oral tablet is used, but the prescriber may adjust the schedule according to local guidelines.

Mifegyne is used to terminate an existing early pregnancy and is therefore contraindicated for ongoing pregnancy. It should not be taken by women who are breastfeeding, as mifepristone can be excreted in breast milk and may affect the infant.

To request Mifegyne, submit an enquiry on the product page at gnhindia.com, specifying 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 required import documentation.

The primary alternative for medical abortion is misoprostol alone, which induces uterine contractions but lacks the progesterone‑blocking effect of mifepristone. Combining mifepristone with misoprostol yields higher efficacy and lower rates of incomplete evacuation compared with misoprostol monotherapy.

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

Mifegyne is taken orally as a single 200 mg tablet, swallowed whole with water. Administration is performed under medical supervision, and the patient is usually instructed to take misoprostol 24–48 hours later to complete the abortion process.

Serious risks include severe infection (sepsis) if retained tissue remains, excessive hemorrhage that may require transfusion or surgical intervention, and rare allergic reactions such as anaphylaxis. Patients should seek immediate medical attention if they experience heavy bleeding, fever, or signs of an allergic response.

Mifegyne is contraindicated in women with ectopic pregnancy, chronic adrenal insufficiency, known hypersensitivity to mifepristone, ongoing anticoagulant therapy, uncontrolled hypertension, or significant cardiovascular disease. It should also be avoided in patients who are breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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