Mifepristone Linepharma (Mifepristone)

Mifepristone acts on the progesterone pathway to facilitate termination of early pregnancy. It is used in the following clinical situations:

• Medical termination of intrauterine pregnancy: induces abortion when combined with a prostaglandin analogue.
• Early pregnancy termination up to 10 weeks gestation: provides a non‑surgical option for women.
• Cushing syndrome (off‑label): may be used to control hypercortisolism in selected patients.

• Mifepristone selectively binds to progesterone receptors, blocking the action of endogenous progesterone. This antagonism leads to decidual breakdown, detachment of the gestational sac, and sensitisation of the uterus to prostaglandins, thereby facilitating expulsion of the pregnancy when used with a prostaglandin agent.

Mifepristone may cause a range of adverse reactions, from mild to severe.

Common Side Effects

• Nausea: mild to moderate stomach upset.
• Vomiting: occasional episodes after dosing.
• Abdominal pain or cramping: typical uterine discomfort.
• Diarrhea: loose stools in some patients.
• Fatigue: feeling of tiredness.
• Headache: transient head pain.

Serious or Rare Side Effects

• Heavy vaginal bleeding: may require medical attention.
• Infection: signs of fever or pelvic infection.
• Severe allergic reaction: rash, swelling, or anaphylaxis.
• Liver toxicity: elevated enzymes or jaundice.
• Uterine rupture: extremely rare but critical emergency.

Mifepristone should be used under strict medical supervision with attention to several safety considerations.

• Confirm gestational age: ensure pregnancy is within approved limits.
• Exclude ectopic pregnancy: perform ultrasound before administration.
• Assess adrenal function: avoid in patients with chronic adrenal insufficiency.
• Avoid in known hypersensitivity: discontinue if allergic reaction occurs.
• Contraindicated in concurrent use of anticoagulants without monitoring.
• Store at below 25°C: keep in the original pack, protect from moisture.

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

Major Interactions (Avoid)

• Rifampin: strong CYP3A4 inducer that reduces mifepristone levels.
• Carbamazepine: enzyme inducer decreasing drug exposure.
• St. John’s wort: herbal inducer that may lower efficacy.

Moderate Interactions (Monitor Closely)

• Ketoconazole: CYP3A4 inhibitor that can increase mifepristone concentrations.
• Efavirenz: antiretroviral that may modestly reduce drug levels.
• Anticoagulants (e.g., warfarin): may enhance bleeding risk; monitor coagulation parameters.