ESTALIS

What it is

Estalis Sequi is a combination pack consisting of two matrix transdermal drug delivery systems (patches). Estalis Sequi Week 1 and 2 contains estradiol and Estalis Sequi Week 3 and 4 contains estradiol and norethisterone acetate (NETA). The patches are transdermal drug delivery systems.

Approved indications

— For the short-term treatment of symptoms of estrogen deficiency in menopausal women who have an intact uterus.

Dosing overview

One treatment cycle of Estalis Sequi consists of 4 matrix patches of Estalis Sequi Week 1 and 2 followed by 4 matrix patches of Estalis Sequi Week 3 and 4. Therapy is started with Estalis Sequi Week 1 and 2 (50 μg/day) matrix patch. Estalis Sequi Week 1 and 2 matrix patch is applied to the skin every 3 to 4 days for the first 14 days of a 28-day cycle, followed by the application of Estalis Sequi Week 3 and 4 50/250 μg/day matrix patch to the skin every 3 to 4 days for the remaining 14 days of the 28-day cycle. The Estalis Sequi Week 3 and 4 dose may be decreased to 50/140 μg/day if progestogen-related side effects occur.

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 myocardial infarction, 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 combined with medroxyprogesterone acetate relative to placebo. Estrogen/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. Should any of these occur or be suspected, estrogen/progestogen therapy should be discontinued immediately. The use of estrogens and progestogens by postmenopausal women has been reported to increase the risk of breast cancer. After a mean follow-up of 5.6 years, the WHI trial reported an increased risk of breast cancer in women who took estrogen plus progestogen. The use of estrogen plus progestogen has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. Women should be advised that changes in the breasts should be reported to their doctor and in addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Contraindications

Estalis Sequi should not be used by women with known or suspected pregnancy; breast-feeding; known, past or suspected cancer of the breast; known or suspected estrogen-dependent neoplasia, including cancer of the endometrium; known or suspected pituitary or hypothalamic tumours; undiagnosed abnormal vaginal bleeding; severe hepatic impairment; endometriosis; connective tissue disease or otosclerosis; active venous thromboembolism (such as deep venous thrombosis or pulmonary embolism), known thrombophilic or thromboembolic disorders, arterial thromboembolic disease (such as coronary heart disease or stroke), or a documented history of these conditions; porphyria; or hypersensitivity to estrogens and progestogens or to any of the components of this product.

Regulatory history

Estalis Continuous products were first listed on the Australian Register of Therapeutic Goods on 11 October 1999. Estalis Sequi patches were first listed on 17 October 2020. Updated registrations of Estalis Sequi and Estalis Continuous were listed on 14 April 2025.