October 2016

New Product - Seasonique

Seasonique (levonorgestrel; ethinyloestradiol) is a 91 day extended regimen oral contraceptive tablet containing a combination of 150 µg of levonorgestrel and 30 µg ethinyloestradiol for 84 days followed by 10 µg ethinyloestradiol tablets for 7 days. Levonorgestrel is a synthetic progestogen and ethinyloestradiol is a synthetic oestrogen. These hormonal components act to inhibit ovulation by supressing gonadotrophin release from the pituitary gland. Seasonique is indicated for use as an oral contraceptive. Seasonique should not be used in presence of any of the following conditions: presence or risk of venous thromboembolism: current VTE (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, protein S deficiency; major surgery with prolonged immobilisation; and a high risk of venous thromboembolism due to the presence of severe or multiple risk factors. Seasonique should also not be used with the presence or risk of arterial thromboembolism (ATE): current ATE or history of ATE (e.g. myocardial infarction or stroke) or prodromal condition (e.g. angina pectoris or transient ischaemic attack); known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies and lupus anticoagulant); history of migraine with focal neurological symptoms; a high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as diabetes mellitus with vascular symptoms, severe hypertension and severe dyslipoproteinaemia; pancreatitis or a history thereof if associated with severe hypertriglyceridemia; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumours (benign or malignant); known or suspected sex steroid influenced malignancies (e.g. of the genital organs or the breasts); undiagnosed vaginal bleeding; known or suspected pregnancy; and in association with herbal remedy St. John’s wort (hypericum perforatum). Seasonique is available as a composite pack containing 3 monthly packs ; months 1 and 2 packs contain 28 tablets with levonorgestrel 150 µg/ethinyloestradiol 30 µg; month 3 pack contains 28 tablets with levonorgestrel 150 µg/ethinyloestradiol 30 µg plus 7 tablets with ethinyloestradiol 10 µg.

This list is a summary of only some of the changes that have occurred over the last month. Before prescribing, always refer to the full product information.

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MIMS Australia
Level 2, 1 Chandos Street
St Leonards NSW 2065
Phone: 1800 800 629