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 tablet for oral use. It is used for medical termination of intrauterine pregnancy up to 10 weeks gestation.
GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

Mifegyne acts as a progesterone receptor antagonist in early pregnancy termination.

  • Medical termination of intrauterine pregnancy up to 10 weeks: induces decidual breakdown and expulsion of the gestational sac.
  • Adjunct to misoprostol in medical abortion: enhances the efficacy of misoprostol‑induced uterine contractions.
  • Pre‑treatment before surgical abortion: reduces uterine vascularity and bleeding, facilitating safer surgical procedures.

How It Works

  • Mifepristone competitively binds to progesterone receptors in the endometrium, blocking the hormone’s action. This antagonism leads to decidual breakdown, detachment of the gestational sac, and sensitisation of the uterus to prostaglandins, allowing misoprostol‑induced uterine contractions to complete the abortion process.

Side Effects

Mifegyne may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Nausea
  • Vomiting
  • Abdominal cramping
  • Vaginal bleeding
  • Diarrhoea
  • Fatigue

Serious or Rare Side Effects

  • Severe infection (sepsis)
  • Heavy bleeding requiring transfusion
  • Allergic reaction (anaphylaxis)
  • Liver injury
  • Uterine rupture
  • Persistent ectopic pregnancy

Precautions & Warnings

Mifegyne should be used only under medical supervision with appropriate patient selection.

  • Confirm gestational age: ensure pregnancy is ≤10 weeks by ultrasound.
  • Verify intrauterine location: exclude ectopic pregnancy before administration.
  • Use in combination with misoprostol: follow approved regimen for optimal efficacy.
  • Contraindicated in chronic adrenal insufficiency or long‑term corticosteroid therapy.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Mifegyne may interact with other medicines that affect its metabolism or hormonal balance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase mifepristone plasma levels.
  • Antifungal agents that inhibit CYP3A4: may raise drug exposure.
  • Antiretroviral protease inhibitors (e.g., ritonavir): potentiate pharmacologic effects.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may increase risk of gastrointestinal bleeding.
  • Hormonal contraceptives: progesterone antagonism can reduce contraceptive efficacy.
  • Anticoagulants: enhanced bleeding tendency when combined with misoprostol‑induced uterine activity.

Frequently Asked Questions

Mifegyne contains mifepristone and is used as a medical abortifacient to terminate an intrauterine pregnancy up to 10 weeks gestation when combined with misoprostol. It works by blocking progesterone, leading to breakdown of the uterine lining and facilitating expulsion of the gestational sac.

Mifepristone is a competitive antagonist of progesterone receptors. By binding to these receptors in the endometrium, it prevents progesterone from maintaining the pregnancy, causing decidual breakdown and making the uterus more responsive to prostaglandins such as misoprostol, which then induce uterine contractions.

The specific dose and regimen of Mifegyne are determined by the prescribing clinician based on gestational age, local guidelines, and combination with misoprostol. Healthcare providers select the appropriate tablet strength and timing to ensure safety and effectiveness.

Mifegyne is intended for use to terminate an early pregnancy and is not used to treat ongoing pregnancy. It is contraindicated in ongoing pregnancy beyond the approved gestational limit and should not be used while breastfeeding, as safety for the infant has not been established.

To place an order, 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 the only progesterone receptor antagonist approved for early medical abortion, offering higher efficacy when combined with misoprostol compared with misoprostol alone. Alternative regimens without mifepristone generally have lower success rates and may require more doses of misoprostol.

Mifegyne tablets should be stored at temperatures below 25 °C, in their original packaging, and protected from moisture and direct sunlight. Keep the product out of reach of children and avoid storing in humid environments such as bathrooms.

Mifegyne is taken orally as a single tablet under medical supervision. After ingestion, misoprostol is administered (usually buccally, sublingually, or vaginally) according to the approved protocol to complete the abortion process.

Serious risks include heavy or uncontrolled bleeding, severe infection (sepsis), allergic reactions such as anaphylaxis, liver injury, and, in rare cases, uterine rupture. Patients should be monitored closely and instructed to seek immediate medical attention if they experience severe abdominal pain, excessive bleeding, or signs of infection.

Mifegyne is contraindicated in women with known or suspected ectopic pregnancy, chronic adrenal insufficiency, long‑term corticosteroid therapy, severe anemia, coagulation disorders, or allergy to mifepristone or misoprostol. It should also not be used beyond 10 weeks gestation or in patients with uncontrolled medical conditions that increase procedural risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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