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 oral use. It is employed in the medical termination of intra‑uterine pregnancy up to 10 weeks gestation and, in some jurisdictions, for the off‑label management of Cushing’s syndrome.

GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established distribution networks and regulatory expertise across EU and other markets. Our quality‑assured batches meet EU pharmacopeial standards and are shipped under controlled conditions.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

Mifepristone acts on progesterone‑dependent pathways to achieve therapeutic outcomes in the following conditions:

  • Medical termination of intrauterine pregnancy (≤10 weeks gestation): induces uterine expulsion of the gestational sac when used with a prostaglandin analogue.
  • Cushing's syndrome (off‑label): blocks glucocorticoid receptors to reduce cortisol‑mediated effects in selected patients.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the uterus, preventing progesterone‑mediated maintenance of the endometrium, leading to decidual breakdown and detachment of the gestational sac. It also exhibits antagonism at glucocorticoid receptors, diminishing cortisol signaling, which underlies its off‑label use in Cushing’s syndrome. The receptor blockade disrupts luteal phase support, sensitizes the myometrium to prostaglandins, and promotes cervical softening, facilitating expulsion of pregnancy tissue.

Side Effects

Mifepristone may cause a range of adverse reactions, which are grouped by frequency.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Vomiting: occasional emesis after dosing.
  • Abdominal pain: cramping or discomfort in the lower abdomen.
  • Vaginal bleeding: spotting or heavier flow during the abortion process.
  • Diarrhea: loose stools occurring within days of administration.
  • Fatigue: transient tiredness or weakness.

Serious or Rare Side Effects

  • Heavy bleeding: excessive hemorrhage requiring medical attention.
  • Infection: signs of uterine or systemic infection such as fever.
  • Incomplete abortion: retained tissue necessitating further intervention.
  • Allergic reaction: rash, itching, or anaphylaxis in rare cases.
  • Liver enzyme elevation: abnormal hepatic function tests observed in isolated reports.

Precautions & Warnings

Before prescribing Mifegyne, clinicians should consider several safety measures:

  • Assess gestational age: confirm pregnancy is ≤10 weeks.
  • Confirm contraindications: exclude ectopic pregnancy, chronic adrenal insufficiency, or severe bleeding disorders.
  • Obtain informed consent: discuss expected outcomes and potential risks with the patient.
  • Monitor vital signs: watch for signs of hemorrhage or hemodynamic instability after dosing.
  • Avoid concomitant CYP3A4 inducers: drugs like rifampin may reduce efficacy.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Mifepristone can interact with other medicines, altering its effectiveness or safety profile.

Major Interactions (Avoid)

  • Rifampin: strong CYP3A4 inducer that markedly lowers plasma concentrations of mifepristone.
  • Carbamazepine: enzyme inducer that may reduce therapeutic levels and compromise efficacy.

Moderate Interactions (Monitor Closely)

  • Azole antifungals (e.g., ketoconazole, fluconazole): CYP3A4 inhibitors that can increase mifepristone exposure.
  • SSRIs: may enhance bleeding risk when combined with prostaglandin agents used in the regimen.
  • Hormonal contraceptives: could diminish the effectiveness of the mifepristone‑misoprostol protocol.

Frequently Asked Questions

Mifegyne contains mifepristone and is used primarily for the medical termination of intra‑uterine pregnancy up to ten weeks gestation. In some regions it is also prescribed off‑label for the management of Cushing’s syndrome, where it helps reduce cortisol activity.

Mifepristone works by competitively blocking progesterone receptors in the uterus, which disrupts the hormonal support needed to maintain the endometrium. This leads to decidual breakdown and detachment of the gestational sac. Its antagonism of glucocorticoid receptors also reduces cortisol signaling, explaining its off‑label use in Cushing’s syndrome.

The specific dose of Mifegyne is determined by the prescribing clinician based on the indication, gestational age, and patient factors. Healthcare providers follow national guidelines and product labeling to select the appropriate regimen; patients should not alter the dose without medical advice.

Mifegyne is intended to end an existing pregnancy and is therefore not used to treat conditions during a viable pregnancy. It is contraindicated in ongoing pregnancy beyond the approved gestational limit and should not be used while breastfeeding, as safety data are insufficient for 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. After submission, the sales team will verify institutional credentials, then provide pricing, availability, shipping details and any required import documentation.

Mifegyne (mifepristone) is often combined with misoprostol and is considered the standard medical regimen for early pregnancy termination in many countries. Alternatives such as methotrexate are less commonly used and may require longer treatment periods. Compared with misoprostol alone, the mifepristone‑misoprostol combination offers higher efficacy and a shorter overall process.

Mifegyne tablets should be stored at ambient temperature, below 25 °C. Keep them in the original packaging, protect from moisture and direct light, and store out of reach of children. Do not refrigerate or freeze the tablets.

Mifegyne is taken orally as a single tablet under the supervision of a qualified healthcare professional. After ingestion, a prostaglandin analogue such as misoprostol is usually administered 24–48 hours later to complete the abortion process. The exact administration schedule is defined by clinical guidelines.

The most serious risks include heavy or uncontrolled bleeding, infection, and incomplete abortion that may require surgical intervention. Rarely, severe allergic reactions or significant liver enzyme elevations can occur. Patients should be monitored closely for these complications and seek immediate medical care if they arise.

Mifegyne should not be used in women with ectopic pregnancy, chronic adrenal insufficiency, severe bleeding disorders, known hypersensitivity to mifepristone, or when the gestational age exceeds ten weeks. It is also contraindicated in patients taking certain enzyme‑inducing drugs that could reduce its effectiveness.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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