GENRX

What it is

Tamoxifen Sandoz is a nonsteroidal triphenylethylene based drug which displays a complex spectrum of oestrogen antagonist and oestrogen agonist like pharmacological effects in different tissues. In breast cancer patients, at the tumour level, tamoxifen acts primarily as an antioestrogen, preventing oestrogen binding to the oestrogen receptor.

Approved indications

— Treatment of breast cancer. — Primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

Dosing overview

Key safety warnings

An increased incidence of endometrial changes including hyperplasia, polyps and cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with tamoxifen treatment. Any patients receiving or having previously received Tamoxifen Sandoz who report abnormal gynaecological symptoms, especially non-menstrual vaginal bleeding, should be promptly investigated. There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during Tamoxifen Sandoz therapy. For treatment of breast cancer, the risks and benefits of Tamoxifen Sandoz should be carefully considered in women with a history of thromboembolic events. Cases of visual disturbances, including infrequent reports of corneal changes, and common reports of retinopathy have been described in patients receiving tamoxifen therapy. Cataracts have commonly been reported in association with the administration of tamoxifen. Tamoxifen should be used cautiously in patients with existing leucopenia or thrombocytopenia. Leucopenia has been observed following the administration of tamoxifen, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions and can sometimes be severe and rarely cases of agranulocytosis have been reported. Decreases in platelet counts (usually to 50,000 to 100,000/mm³, infrequently lower) have been occasionally reported in patients taking tamoxifen for breast cancer. The use of tamoxifen for reduction of breast cancer risk has been associated with reduced bone density in premenopausal women. Whether this may result in an increased risk of fracture is not known. Pre-menopausal women taking tamoxifen for this reason should be advised regarding measures to maintain bone health.

Contraindications

Tamoxifen Sandoz must not be given during pregnancy. Tamoxifen Sandoz should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. When considered for primary reduction of breast cancer risk, Tamoxifen Sandoz is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus.

Regulatory history

Tamoxifen Sandoz was first approved on 26 September 2001. GENRX TAMOXIFEN (tamoxifen as citrate) 20 mg tablet was first listed on the ARTG on 24 July 2020 under licence category RE.