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 treats medical termination of intrauterine pregnancy up to 49 days gestation and is also used off‑label for Cushing's syndrome.

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

Mifepristone is a progesterone receptor antagonist used in specific reproductive and endocrine indications.

  • Medical termination of intrauterine pregnancy (up to 49 days gestation): induces uterine lining breakdown and facilitates expulsion of the embryo.
  • Cushing's syndrome (off‑label): reduces cortisol production by blocking glucocorticoid receptors.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the uterus, blocking the hormone’s action that maintains the endometrial lining, leading to decidual breakdown and cervical softening. It also antagonises glucocorticoid receptors, contributing to its effect in cortisol‑related disorders.

Side Effects

Mifepristone may cause a range of adverse reactions.

Common Side Effects

  • Abdominal pain
  • Vaginal bleeding
  • Nausea
  • Diarrhoea
  • Fatigue
  • Headache

Serious or Rare Side Effects

  • Heavy uterine bleeding requiring transfusion
  • Infection
  • Uterine rupture
  • Allergic reaction (anaphylaxis)
  • Elevated liver enzymes
  • Severe abdominal pain

Precautions & Warnings

Mifegyne should be used only under medical supervision with careful patient assessment.

  • Confirm gestational age: ensure pregnancy is ≤49 days by ultrasound.
  • Medical supervision: administer under a qualified healthcare professional.
  • Contraindications: avoid in ectopic pregnancy, chronic adrenal failure, anticoagulant therapy.
  • Drug interactions: review concomitant medications, especially CYP3A4 inducers.
  • Pregnancy testing: verify pregnancy status before use.
  • Store at ambient temperature: keep below 25°C in original packaging, protect from moisture.

Avoid Interactions

Mifegyne can interact with several drug classes; monitoring is essential.

Major Interactions (Avoid)

  • Rifampin (CYP3A4 inducer): may reduce efficacy of mifepristone.
  • Carbamazepine (CYP3A4 inducer): may lower drug levels.
  • Anticoagulants (e.g., warfarin): increased risk of bleeding when combined with misoprostol regimen.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): may increase mifepristone exposure.
  • Antiretrovirals (e.g., efavirenz): may alter metabolism.
  • Hormonal contraceptives: may have reduced effectiveness during treatment.

Frequently Asked Questions

Mifegyne contains mifepristone, a progesterone receptor antagonist indicated for medical termination of intrauterine pregnancy up to 49 days gestation and, in some jurisdictions, used off‑label for management of Cushing's syndrome. It must be prescribed by a qualified health professional and administered as part of a regulated protocol.

Mifepristone binds competitively to progesterone receptors in the uterus, blocking the hormone’s action that maintains the endometrial lining. This antagonism leads to decidual breakdown, cervical softening, and sensitisation of the uterus to prostaglandins, facilitating expulsion of the conceptus. It also antagonises glucocorticoid receptors, which underlies its off‑label use in Cushing’s syndrome.

The specific dose of Mifegyne is determined by the prescribing clinician based on the approved protocol for the intended indication, gestational age, and patient factors. In the standard medical abortion regimen, a single 200 mg oral tablet is commonly used, but the exact regimen should be confirmed by the treating physician.

Mifegyne is contraindicated in ongoing pregnancy beyond the approved gestational limit and is classified as pregnancy category X because it terminates pregnancy. It is also not recommended for breastfeeding women, as mifepristone can be excreted in milk and may affect the infant. Women should discuss alternatives with their healthcare provider.

To request Mifegyne, 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 (including any temperature requirements) and assistance with import documentation.

The most common alternative to Mifegyne in medical abortion is misoprostol, which is a prostaglandin analogue that induces uterine contractions. Mifegyne initiates the process by antagonising progesterone, creating a receptive uterine environment, while misoprostol completes the expulsion. Using both drugs sequentially is standard practice, offering higher efficacy than misoprostol alone.

Mifegyne tablets should be stored at ambient temperature, preferably below 25 °C, in their original blister pack to protect from moisture and light. Keep the product out of reach of children and avoid storing in bathrooms or near heat sources. No refrigeration is required for this oral tablet formulation.

Mifegyne is taken orally as a single tablet, usually under direct supervision of a qualified healthcare professional. After ingestion, a follow‑up dose of misoprostol is typically prescribed 24–48 hours later to complete the abortion process. The exact administration schedule, including timing and route of any additional medication, is defined by the treating clinician.

The most serious adverse events include heavy or uncontrolled uterine bleeding that may require transfusion, infection, and rare cases of uterine rupture. Allergic reactions such as anaphylaxis can also occur. Patients should be monitored closely for signs of severe bleeding, fever, or abdominal pain and seek immediate medical attention if these arise.

Mifegyne is contraindicated in women with confirmed ectopic pregnancy, chronic adrenal insufficiency, anticoagulant therapy, known hypersensitivity to mifepristone, or when the gestational age exceeds 49 days. It should also be avoided in patients with severe cardiovascular disease or uncontrolled hypertension. A thorough medical assessment is required before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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