FIXTA

What it is

FIXTA contains 60 mg raloxifene hydrochloride, which is equivalent to 56 mg raloxifene free base. It is supplied as tablets. Raloxifene is a selective oestrogen receptor modulator (SERM). It exerts the positive effects of oestrogen on bone and lipid metabolism, while specifically antagonising some of the potentially negative effects of oestrogen on uterine and breast tissues.

Approved indications

— Prevention and treatment of osteoporosis in postmenopausal women. — Reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis. — Reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer, defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified Gail model).

Dosing overview

The recommended dosage is one 60 mg FIXTA tablet per day orally, which may be taken at any time of day without regard to meals. No dose adjustment is necessary for the elderly. Supplemental calcium should be added to the diet if daily intake is inadequate.

Key safety warnings

In a multicentre, placebo-controlled, randomised study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events followed for a median of 5.6 years, there was an increased risk of mortality due to stroke in the group taking raloxifene, with stroke mortality of 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene. The risk-benefit balance of raloxifene for treatment or prevention of osteoporosis, or reduction in risk of invasive breast cancer, in postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischaemic attack or atrial fibrillation, should be considered when prescribing FIXTA. Raloxifene is associated with an increased risk for venous thromboembolic events that appears to be similar to the reported risk associated with current use of hormone replacement therapy. Raloxifene should be discontinued in the event of a condition or illness leading to a prolonged period of immobilisation, as soon as possible with illness, or from three days before prolonged immobilisation is likely, and therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile. In patients with a history of oral oestrogen-induced hypertriglyceridaemia (≥5.6 mmol/L), raloxifene may be associated with a marked increase in serum triglycerides, and patients with this medical history should have serum triglycerides monitored when taking raloxifene.

Contraindications

FIXTA is contraindicated in women who are or may become pregnant, as raloxifene may cause foetal harm when administered to a pregnant woman. FIXTA is contraindicated in women with active or a past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. FIXTA is contraindicated in women with hypersensitivity to raloxifene or other ingredients in the tablet. FIXTA is contraindicated for use in males and is only for use in postmenopausal women.

PBS listing

Information regarding PBS listing for FIXTA is not available in the provided source documents.

Regulatory history

FIXTA 60 raloxifene hydrochloride 60 mg tablets were first listed on the Australian Register of Therapeutic Goods on 26 September 2013.