MIFEPRISTONE

What it is

Mifepristone Linepharma contains 200 mg of mifepristone per tablet. The pharmaceutical form is an uncoated tablet, white to off-white, round biconvex, 11 mm diameter, with MF debossed on one side. Mifepristone is a synthetic steroid with an antiprogestational action as a result of competition with progesterone at the progesterone receptors.

Approved indications

— Preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.

Dosing overview

The dose is 200 mg of mifepristone (1 tablet containing 200 mg) orally, followed 36 to 48 hours later by the scheduled prostaglandin analogue administration, which will be repeated as often as indicated. Mifepristone Linepharma should not be taken within 2 hours of a meal.

Key safety warnings

Rare serious cardiovascular accidents have been reported following administration of prostaglandins, and women with risk factors for cardiovascular disease or established cardiovascular disease should be treated with caution. Due to the antiglucocorticoid activity of mifepristone, special care should be taken in case of suspected acute adrenal failure. The efficacy of long-term corticosteroid therapy, including inhaled corticosteroids in asthmatic patients, may be decreased during the 3 to 4 days following intake of mifepristone, and therapy should be adjusted. Serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone, and doctors should be alert to this possibility. A fever, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection. Severe cutaneous adverse reactions, including toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in association with mifepristone. In patients who experience severe cutaneous adverse reactions, treatment should be immediately discontinued, and re-treatment is not recommended. Bleeding may occur prior to prostaglandin administration and post-expulsion in the second trimester, which may lead to a significant decrease in haemoglobin levels and can be large enough to necessitate a blood transfusion in around 0.5% of women.

Contraindications

Mifepristone Linepharma should not be prescribed in the following situations: lack of access to emergency medical care until complete expulsion is recorded; suspected or confirmed ectopic pregnancy; uncertainty about gestational age; chronic adrenal failure; concurrent long-term corticosteroid therapy; suspected or known haemorrhagic disorders or treatment with anticoagulants; hypersensitivity to mifepristone, the prostaglandin analogue to be used, or any of the excipients; contraindication to the prostaglandin analogue selected; or pregnancy not confirmed by an ultrasound or biological test such as urine or serum HCG.

Regulatory history

Mifepristone Linepharma 200 mg tablet was first listed on the Australian Register of Therapeutic Goods on 29 August 2012. The product received TGA approval on 2 August 2012 for medical termination of a developing intra-uterine pregnancy and for preparation for prostaglandin analogues in terminations beyond the first trimester.