Mifegyne

/ Lapidot

MIFEGYNE® must not be administered if there is doubt as to the existence and age of pregnancy, or in case of extra-uterine pregnancy. The prescribing doctor should in any case perform an ultrasound scan and/or measure Beta-hCG before administration.
Posology
1) Medical termination of developing intra-uterine pregnancy.
The method of administration which will be prescribed by the physician and applied in the presence of the practitioner or of a health professional will be as follows:
– Up to 49 days of amenorrhea:
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 μg orally (pregnancies up to 49 days of amenorrhea).
– Between 50-63 days of amenorrhea
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Alternatively, 200 mg of mifepristone (i.e. 1 tablet of 200 mg) can also be used in a single oral dose, followed 36 to 48 hours later, by the administration of the
prostaglandin analogue gemeprost 1 mg per vaginam (see section 5.1.
pharmacodynamic properties).
Information on the posology of misoprostol or gemeprost can be found in the respective product information.
2) Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester.
Mifepristone is taken as a single 200 mg (1 tablet) oral dose, followed 36 to 48 hours later (but not beyond) by surgical termination of pregnancy.
3) Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons.
600 mg of Mifepristone (i.e. 3 tablets of 200 mg each) taken in a single oral dose, 36 to 48 hours prior to scheduled prostaglandin administration which will be repeated as often as indicated.
4) Labour induction in foetal death in utero
Mifepristone is taken as a single 600 mg (e.g. 3 tablets of 200 mg each) oral daily dose, for two consecutive days.
Labour should be induced by the usual methods if it has not started within 72 hours following the first administration of mifepristone.
Vomiting within 45 minutes after the intake could lead to a decrease in mifepristone efficacy: oral intake of a new mifepristone 600 mg dose (e.g. 3 tablets of 200 mg each) is recommended in this case.
Paediatric population: Only limited data are available on the use of mifepristone in adolescents.
Method of administration: Mifepristone tablets are for oral use only and should not be taken by any other route of administration.

1) Medical termination of developing intra-uterine pregnancy. In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea.
2) Softening and dilatation of the cervix uteri prior to surgical termination of
pregnancy during the first trimester.
3) Preparation for the action of prostaglandin analogues in the termination of
pregnancy for medical reasons (beyond the first trimester)
4) Labour induction in foetal death in utero. In patients where prostaglandin or oxytocin cannot be used.

In all indications:
– chronic adrenal failure
– hypersensitivity to the active substance or to any of the excipients.
– severe asthma uncontrolled by therapy
– inherited porphyria
In the indication: medical termination of developing pregnancy
– pregnancy NOT confirmed by ultrasound scan or biological tests
– pregnancy beyond 63 days of amenorrhea
– suspected extra-uterine pregnancy
– contra-indication to the prostaglandin analogue selected
In the indication: Softening and Dilatation of the Cervix Uteri prior to Surgical Termination of Pregnancy:
– pregnancy not confirmed by ultrasound scan or biological test
– pregnancy of 84 days of amenorrhea and beyond (according to legal requirements)
– suspected extra-uterine pregnancy
In the indication: Preparation for the Action of Prostaglandin Analogues in the Termination of Pregnancy for Medical Reasons (beyond the first trimester)
– Contra-indications to the prostaglandin analogue selected

See prescribing information for full details.

See prescribing information for full details.

No interaction studies have been performed. On the basis of this drug’s metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St. John’s Wort and certain anticonvulsivants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of mifepristone).
See prescribing information for full details.

Pregnancy: – Women should be informed, that due to the risk of failure of the medical method of pregnancy termination and to the unknown risk to the foetus, the follow-up visit is mandatory.
– Should a failure of the method be diagnosed at the follow-up visit (viable ongoing pregnancy), and should the patient still agree, pregnancy termination should be completed by another method.
– Should the patient wish to continue with her pregnancy, a careful ultrasound monitoring of the pregnancy, with a special attention to the limbs, must be established in a specialised centre.
Breastfeeding: Mifepristone is excreted in mother’s milk in small amounts. Consequently, mifepristone use should be avoided during breastfeeding.
See prescribing information for full details.

No case of overdose has been reported.
In the event of accidental massive ingestion, signs of adrenal failure might occur. Signs of acute intoxication, may require specialist treatment including the administration of dexamethasone.