FEMME-TAB

What it is

Seasonique is a 91-day extended-regimen oral contraceptive tablet. Each pink tablet contains 150 µg levonorgestrel and 30 µg ethinylestradiol, whilst each white tablet contains 10 µg ethinylestradiol. Each composite pack contains 84 round pink film coated tablets containing levonorgestrel and ethinylestradiol and 7 white, round, biconvex film-coated tablets containing ethinylestradiol.

Approved indications

— Oral contraceptive use.

Dosing overview

Seasonique is an extended-regimen oral contraceptive where tablets are taken continuously for 91 days. One pink tablet containing levonorgestrel and ethinylestradiol is taken daily for 84 consecutive days, followed by one white ethinylestradiol tablet for 7 days, during which time withdrawal bleeding usually occurs. Each subsequent 91-day cycle is started without interruption on the same day of the week on which the patient began her first dose of Seasonique, following the same schedule.

Key safety warnings

Epidemiological studies have suggested an association between the use of combined oral contraceptives containing ethinylestradiol and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep venous thrombosis, and pulmonary embolism. The use of any combined oral contraceptive increases the risk of venous thromboembolism compared with no use, with the highest risk in the first ever year of use. Data from a retrospective cohort study suggest that the risk of venous thromboembolism associated with Seasonique may be 1.4 fold higher compared with levonorgestrel-containing combined hormonal contraceptives used in a 28 day cycle. In case of severe gastro-intestinal disturbances such as vomiting or diarrhoea, absorption may not be complete and additional contraceptive measures should be taken.

Contraindications

Seasonique should not be used in the presence of current venous thromboembolism (on anticoagulants) or history of deep venous thrombosis or pulmonary embolism. Known hereditary or acquired predisposition for venous thromboembolism such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, or protein S deficiency contraindicates use. Current arterial thromboembolism or history of arterial thromboembolism such as myocardial infarction or stroke, or prodromal conditions such as angina pectoris or transient ischaemic attack contraindicates use. History of migraine with focal neurological symptoms contraindicates use. Pancreatitis or a history thereof if associated with severe hypertriglyceridemia contraindicates use, as does severe hepatic disease when liver function values have not returned to normal. Known or suspected sex steroid-influenced malignancies of the genital organs or breasts, undiagnosed vaginal bleeding, and known or suspected pregnancy contraindicates use. Concomitant use with herbal remedy St. John's Wort (hypericum perforatum) and hypersensitivity to any of the ingredients contained in Seasonique contraindicates use.

Regulatory history

Seasonique was first listed on the Australian Register of Therapeutic Goods on 10 January 2012 under the brand name FEMME-TAB with multiple strength formulations registered.