EVISTA

What it is

EVISTA contains 60 mg raloxifene hydrochloride per tablet, equivalent to 56 mg raloxifene free base. Raloxifene is a selective oestrogen receptor modulator (SERM) with agonistic effects at some oestrogen receptors and antagonistic effects at others. 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 greater than 1.66% based on the modified Gail model.

Dosing overview

The recommended dosage is one 60 mg EVISTA 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.

Key safety warnings

In a multicentre double-blind placebo-controlled randomised parallel 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 EVISTA 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 EVISTA. 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. Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis occurred at a frequency of approximately 0.7% or 3.25 cases per 1,000 patient years, with a relative risk of 2.32 in raloxifene treated patients compared to placebo. 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

EVISTA is contraindicated in women who are or may become pregnant, as raloxifene may cause foetal harm when administered to a pregnant woman. EVISTA 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. EVISTA is also contraindicated in women with hypersensitivity to raloxifene or other ingredients in the tablet. EVISTA is contraindicated for use in males and is only for use in postmenopausal women.

PBS listing

The tablet containing raloxifene hydrochloride 60 mg is listed on the PBS with 2 items, streamlined restriction status, and an ex-manufacturer price of A$19.47.

Regulatory history

EVISTA raloxifene hydrochloride 60 mg tablet was first listed on the ARTG on 19 January 1999. The product was first approved on 26 November 2008.