LENEST

What it is

Lenest is a combined oral contraceptive tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen ethinylestradiol.

Approved indications

— Oral contraception.

Dosing overview

One tablet is to be taken daily. The tablets must be taken in the order directed on the package at about the same time each day, with some liquid as needed. Daily tablet taking should be continuous for 28 consecutive days, starting with a pink active tablet marked with the corresponding day of the week from the green area of the pack. Each subsequent pack is to be started the day after the last tablet of the previous pack. When taken correctly, Lenest has a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

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, cerebrovascular accidents, deep venous thrombosis and pulmonary embolism. The use of any combined hormonal contraceptive increases the risk of venous thromboembolism compared with no use. The risk is highest in the first ever year of use and there is some evidence that the risk is increased when a combined hormonal contraceptive is re-started after a break in use of 4 weeks or more. Products that contain levonorgestrel are associated with the lowest risk of venous thromboembolism. Women should be informed of the symptoms of venous thromboembolism and be advised to seek urgent medical attention if symptoms develop and to inform the healthcare professional that she is taking a combined hormonal contraceptive. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently taking combined oral contraceptives. The excess risk gradually disappears during the course of the 10 years after cessation of use. Lenest is intended to prevent pregnancy. It does not protect against sexually transmitted infections, including HIV infections.

Contraindications

Lenest should not be used in the presence of current venous thromboembolism (on anticoagulants) or history of deep venous thrombosis or pulmonary embolism. Lenest should not be used in the presence of known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency or protein S deficiency. Lenest should not be used in the presence of current arterial thromboembolism or history of arterial thromboembolism (for example myocardial infarction or stroke) or prodromal condition (for example angina pectoris or transient ischaemic attack). Lenest should not be used in patients with history of migraine with focal neurological symptoms. Lenest should not be used in the presence or history of severe hepatic disease as long as liver function values have not returned to normal. Lenest is contraindicated for concomitant use with the medicinal products glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir or dasabuvir and combinations of these. Lenest should not be used in the presence or history of malignant conditions of the genital organs, the breasts, or other organs, if sex steroid-influenced. Lenest should not be used in known or suspected pregnancy.

Regulatory history

Lenest 20 ED (levonorgestrel 100 microgram/ethinylestradiol 20 microgram) was first listed on the Australian Register of Therapeutic Goods on 21 November 2014.