FEMOSTON

What it is

Femoston 2/10 contains estradiol 2 mg and estradiol 2 mg with dydrogesterone 10 mg in a tablet blister pack composite pack. Femoston 1/10 contains estradiol 1 mg and estradiol 1 mg with dydrogesterone 10 mg in a tablet blister pack composite pack. The estrogen component substitutes for the loss of endogenous oestrogen production due to natural or surgical menopause in hysterectomised women.

Approved indications

— Short-term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. — Treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus (estradiol with norethisterone acetate oral tablets).

Key safety warnings

Hormone replacement therapy should not be initiated or continued to prevent or treat cardiovascular disease. For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. HRT should be prescribed at the lowest effective doses and for the shortest duration consistent with the treatment goals and risks for the individual woman. HRT is associated with a 1.3- to 3-fold risk of developing venous thromboembolism, that is deep venous thrombosis or pulmonary embolism. Combined oestrogen-progestagen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The overall evidence shows an increased risk of breast cancer in women taking oestrogen-only HRT or oestrogen-progestagen combinations that is dependent on the duration of taking HRT, with an increased risk becoming apparent after about 3 years. In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed oestrogens. The appropriate addition of a progestagen to an oestrogen regimen lowers this additional risk.

Contraindications

Femoston is contraindicated in known, suspected, or past history of breast cancer; known, suspected, or past history of oestrogen-dependent neoplasia such as endometrial cancer; vaginal bleeding of unknown aetiology; untreated endometrial hyperplasia; previous or current venous thromboembolism; known thrombophilic disorders; active or recent arterial thromboembolic disease; acute liver disease or history of liver disease where liver function tests have failed to return to normal; known hypersensitivity to any of the components; porphyria; and known or suspected pregnancy.

Regulatory history

Femoston 2/10 was first listed on the Australian Register of Therapeutic Goods on 8 September 2000. Femoston 1/10 was first listed on 8 May 2014. In November 2017, the Pharmaceutical Benefits Scheme Advisory Committee recommended an amendment to the PBS listing to allow estradiol with norethisterone acetate oral tablets to be used for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.