Femoston Conti

What it is

FEMOSTON-CONTI contains estradiol (as hemihydrate) and dydrogesterone and is supplied as immediate-release film-coated tablets for oral use. Each blister strip contains 14 round, biconvex, white, film-coated tablets, each containing 1 mg estradiol (as hemihydrate), and 14 round, biconvex, grey, film-coated tablets, each containing 1 mg estradiol (as hemihydrate) combined with 10 mg dydrogesterone.

Approved indications

— Hormone replacement therapy (HRT) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. — Prevention of postmenopausal bone mineral density loss in women.

Dosing overview

One tablet is administered orally daily without interruption. Therapy should be started with FEMOSTON 1/10 mg, and depending on the clinical response to treatment, the dose can be adjusted to individual needs. If the dose selected does not alleviate the symptoms of oestrogen deficiency, it should be increased, using FEMOSTON 2/10 mg. Treatment should begin with the administration of the white, 1 mg estradiol tablets for the first 14 days of a 28-day cycle, followed by 14 days administration of the grey 1 mg estradiol/10 mg dydrogesterone combination tablets. This sequence is also indicated on the blister strip. When all 28 tablets in the pack have been taken, another pack is started without interruption.

Key safety warnings

Estrogens and progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Oestrogen/progestogen therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism. The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen/progestogen HRT or oestrogen-only HRT, that is dependent on the duration of taking HRT. The risk of breast cancer with oestrogen plus dydrogesterone was lower than that noted with other synthetic progestogens. Less than 5 years of use of oestrogen plus dydrogesterone was not associated with a statistically significant increased risk of breast cancer (RR 1.21; 95% CI 0.90 to 1.61). In the oestrogen plus progestogen sub-study of WHI, a 2-fold greater rate of venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, was observed in women receiving conjugated equine estrogens plus medroxyprogesterone acetate compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the oestrogen plus progestogen treated group compared to 16 per 10,000 women-years in the placebo group. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilisation. Treatment should not be restarted until the woman is completely mobilised.

Contraindications

Women with contraindications include those who have had a hysterectomy, those with known or suspected carcinoma of the breast, endometrium or other oestrogen dependent neoplasia, those with known or suspected progestogen dependent neoplasms, those with untreated endometrial hyperplasia, those with active or chronic liver disease or a history of liver disease where the liver function tests have failed to return to normal, those with cerebrovascular accident or a past history of these conditions associated with previous oestrogen use, and those with previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) or cerebrovascular accident. Additional contraindications include known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency), active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction), abnormal genitourinary tract bleeding of unknown aetiology, porphyria, known or suspected pregnancy, lactation, and known hypersensitivity to any ingredients contained in FEMOSTON tablets.

PBS listing

FEMOSTON-CONTI tablet blister pack is registered on the ARTG (registration number 78654) and was first listed on 2001-05-30. In November 2017, the PBAC recommended an amendment to the current PBS listing to allow oestradiol + dydrogesterone oral tablets to be used for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.

Regulatory history

FEMOSTON-CONTI was first registered on the ARTG on 2001-05-30. In November 2017, the PBAC recommended a change to the PBS listing for oestradiol + dydrogesterone oral tablets for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.