Mifepristone

May be taken with or without food. Avoid grapefruit juice.

Termination of pregnancy: Chronic adrenal failure, uncontrolled severe asthma, inherited porphyria, intrauterine device in place, ectopic pregnancy, pregnancy not confirmed by ultrasound scan or biological test, suspected extra-uterine pregnancy, undiagnosed adnexal mass, haemorrhagic disorder. Concomitant use with anticoagulant or long-term corticosteroid therapy. Treatment of hyperglycaemia in patients with Cushing's syndrome: History of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma. Pregnancy. Concomitant use with lovastatin, simvastatin or CYP3A substrates with narrow therapeutic ranges (e.g. ciclosporin, fentanyl, quinidine, tacrolimus, sirolimus, dihydroergotamine, ergotamine), long-term corticosteroid therapy for life-saving purposes (e.g. immunosuppression following organ transplant).

Termination of pregnancy: Patient with history and active CV disease, haemostatic disorders, hypocoagulability, anaemia. Treatment of hyperglycaemia in patients with Cushing's syndrome: Patient with haemorrhagic disorder, hypokalaemia, adrenal insufficiency, CV disease. Concomitant use with anticoagulants, QT-prolonging agents, strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin). Hepatic and renal impairment. Lactation. Patient counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Termination of pregnancy: Monitor Hb, haematocrit and RBC count in cases of heavy bleeding; CBC in patients who show signs of infection. Confirm pregnancy and Rh status prior to termination of pregnancy. Conduct clinical exam, hCG testing or ultrasound to confirm complete termination of pregnancy. Treatment of hyperglycaemia in patients with Cushing's syndrome: Monitor K level (1-2 weeks after initiation or dose increase, then periodically thereafter), thyroid function, blood sugar, psychiatric symptoms and cushingoid appearance. Monitor for signs and symptoms of adrenal insufficiency.

Significant: Adrenal insufficiency, hypokalaemia, QT prolongation. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal cramps, dry mouth, constipation. General disorders and administration site conditions: Fatigue, peripheral oedema. Infections and infestations: Bacterial or viral infection, sinusitis, nasopharyngitis. Investigations: Abnormal thyroid function test. Metabolism and nutrition disorders: Decreased appetite, anorexia. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, back pain, pain in extremity. Nervous system disorders: Headache, dizziness, somnolence. Psychiatric disorders: Anxiety. Reproductive system and breast disorders: Uterine contractions, endometrial hypertrophy. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, toxic epidermal necrolysis. Vascular disorders: Hypertension.
Potentially Fatal: Toxic and septic shock.

Increased serum concentration with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin). Decreased serum concentration with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine). May increase serum concentration of CYP2C8/2C9 substrates (e.g. fluvastatin, NSAIDs, repaglinide) and CYP2B6 substrates (e.g. efavirenz, bupropion). May diminish the therapeutic effect of hormonal contraceptives. May enhance the effect of QT-prolonging agents.

Drugs Acting on the Uterus

G03XB01 - mifepristone ; Belongs to the class of antiprogestogens.