Mifepristone

Chemical formula: C₂₉H₃₅NO₂  Molecular mass: 429.594 g/mol  PubChem compound: 55245

Therapeutic indications

Mifepristone is indicated for:

Medical termination of developing intra-uterine pregnancy

Population group: women, only adults (18 - 65 years old)

In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester

Population group: women, only adults (18 - 65 years old)

Dilation of cervical canal

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Preparation for the action of prostaglandin analogues in the termination of pregnancy

Population group: women, only adults (18 - 65 years old)

Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Labour induction in foetal death in utero

Population group: women, only adults (18 - 65 years old)

In patients where prostaglandin or oxytocin cannot be used.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Mifepristone is contraindicated in the following cases:

Chronic adrenal failure

Adrenal cortical hypofunction

Severe asthma uncontrolled by therapy

Severe asthma

Inherited porphyria

Inherited disorder of porphyrin metabolism

Pregnancy not confirmed by ultrasound scan or biological tests

Not pregnant

Pregnancy beyond 63 days of amenorrhea

at least one of
Gestation 9- 13 weeks
Gestation greater than 20 weeks
Second trimester pregnancy

Suspected extra-uterine pregnancy

Ectopic pregnancy

Pregnancy of 84 days of amenorrhea and beyond

at least one of
Second trimester pregnancy
Third trimester pregnancy

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Summary of Product Characteristics (SPC) 2019: MIFEGYNE Tablet
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