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 and for management of early pregnancy loss.

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 (mifepristone) is an antiprogestogen used in early pregnancy management.
  • Medical termination of intrauterine pregnancy (≤10 weeks gestation): induces decidual breakdown and facilitates expulsion of the gestational sac.
  • Early pregnancy loss (≤10 weeks gestation): promotes evacuation of retained products of conception.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the uterine lining, blocking the hormone's action. This antagonism leads to breakdown of the decidua and detachment of the gestational sac. In addition, the drug sensitizes the uterus to prostaglandins, enhancing uterine contractility and facilitating expulsion of pregnancy tissue.

Side Effects

Mifegyne may cause a range of adverse reactions, most of which are mild and self‑limiting.

Common Side Effects

  • Nausea or vomiting
  • Abdominal cramping or pain
  • Vaginal bleeding or spotting
  • Diarrhea
  • Headache
  • Fatigue

Serious or Rare Side Effects

  • Heavy or prolonged bleeding requiring medical intervention
  • Severe infection (sepsis) after incomplete evacuation
  • Allergic reaction or anaphylaxis
  • Liver enzyme elevation or hepatic dysfunction
  • Uterine rupture (extremely rare)

Precautions & Warnings

Before prescribing Mifegyne, clinicians should consider several safety measures.

  • Confirm gestational age: ensure pregnancy is ≤10 weeks.
  • Verify diagnosis: rule out ectopic pregnancy.
  • Review medical history: avoid in patients with chronic adrenal failure or anticoagulant therapy.
  • Monitor bleeding: watch for excessive hemorrhage after administration.
  • Assess for contraindications: such as severe anemia or severe cardiovascular disease.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce mifepristone effectiveness.
  • Concurrent prostaglandin analogues: can increase risk of uterine hyperstimulation.
  • Anticoagulants (e.g., warfarin): may amplify bleeding risk.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): may raise mifepristone plasma levels.
  • NSAIDs: could mask abdominal pain, complicating assessment.
  • Hormonal contraceptives: effectiveness may be reduced, requiring alternative contraception.

Frequently Asked Questions

Mifegyne contains mifepristone and is used for the medical termination of intrauterine pregnancy up to 10 weeks gestation and for the management of early pregnancy loss. It works by blocking progesterone, leading to breakdown of the uterine lining and facilitating expulsion of pregnancy tissue.

Mifepristone is a progesterone receptor antagonist. By binding to progesterone receptors in the uterus, it prevents the hormone from maintaining the pregnancy, causing decidual breakdown. The drug also sensitizes the uterus to prostaglandins, which enhances uterine contractions and helps expel the gestational sac.

The dose of Mifegyne is determined by the prescribing clinician based on the specific clinical scenario, gestational age, and local guidelines. Healthcare professionals prescribe the appropriate tablet strength and schedule, and patients should follow the prescriber's instructions exactly.

Mifegyne is classified as Pregnancy Category X, meaning it is contraindicated in ongoing pregnancy except for its intended use in termination. It should not be used during breastfeeding because mifepristone can be excreted in breast milk and may affect the infant.

To order Mifegyne, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details and import documentation.

Mifegyne (mifepristone) is the standard antiprogestogen used in combination with misoprostol for early medical termination. Compared with surgical methods, it offers a non‑invasive option with high efficacy up to 10 weeks. Alternative drugs, such as methotrexate, are less commonly used for this indication and have different safety profiles.

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 do not use if the packaging is damaged.

Mifegyne is taken orally as a tablet. The prescriber determines the exact dosage and timing, which is usually followed by a dose of misoprostol taken later to complete the termination process. Administration should occur under medical supervision with appropriate follow‑up.

Serious risks include heavy or prolonged vaginal bleeding, severe infection (sepsis) after incomplete evacuation, allergic reactions including anaphylaxis, and, rarely, uterine rupture. Patients should seek immediate medical attention if they experience excessive bleeding, fever, severe abdominal pain, or signs of an allergic reaction.

Mifegyne should not be used in patients with confirmed ectopic pregnancy, chronic adrenal insufficiency, severe anemia, uncontrolled cardiovascular disease, or those taking anticoagulant therapy that cannot be safely managed. It is also contraindicated in individuals with known hypersensitivity to mifepristone or any tablet excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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