SEASONIQUE

What it is

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

Approved indications

— Seasonique is indicated for use as an oral contraceptive.

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 (COCs) 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 COC increases the risk of venous thromboembolism (VTE) compared with no use, with the risk highest in the first ever year of use and with some evidence that the risk is increased when a COC is re-started after a break in use of 4 weeks or more. Data from a retrospective cohort study suggest that the risk of VTE associated with Seasonique may be 1.4 fold higher (HR 1.40, 95% CI 0.90 – 2.19) 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 with 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 are contraindications. Current arterial thromboembolism or history of arterial thromboembolism (such as myocardial infarction or stroke) or prodromal condition (such as angina pectoris or transient ischaemic attack) contraindicate use. History of migraine with focal neurological symptoms is a contraindication. Pancreatitis or a history thereof if associated with severe hypertriglyceridemia, and presence or history of severe hepatic disease as long as liver function values have not returned to normal are contraindications. Presence or history of liver tumours (benign or malignant) and known or suspected sex steroid-influenced malignancies (such as of the genital organs or the breasts) contraindicate use. Undiagnosed vaginal bleeding, known or suspected pregnancy, hypersensitivity to any of the ingredients contained in Seasonique, and concomitant use with herbal remedy St. John's Wort (hypericum perforatum) are contraindications. Concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir is contraindicated.

Regulatory history

Seasonique was first listed on the ARTG on 24 May 2016 (licence category RE). The TGA approved Seasonique for use as an oral contraceptive on 23 May 2016, following a major variation submission for its novel extended-cycle dosage regimen. Clinical data supported the pharmacokinetics and the rationale for the extended-cycle regimen, which aims to maintain ovarian suppression, reduce hormone withdrawal symptoms, and improve bleeding profiles.