NEXTSTELLIS

What it is

NEXTSTELLIS is a medicine containing estetrol and drospirenone. Estetrol is a synthetic analogue of a native human estrogen and drospirenone is a synthetic progestational compound. Each active tablet contains 14.2 mg estetrol (equivalent to 15 mg of estetrol monohydrate) and 3 mg of drospirenone. The medicine is supplied as film-coated tablets, with pink active tablets and white inactive tablets. NEXTSTELLIS is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Prevention of pregnancy in women of reproductive potential.

Dosing overview

NEXTSTELLIS is swallowed whole once a day, with one tablet taken daily for 28 consecutive days. The administration cycle consists of 24 active pink tablets taken consecutively followed by 4 inactive white tablets. Tablets must be taken every day at about the same time of the day so that the interval between consecutive tablets is the same.

Key safety warnings

**Thromboembolism.** Combined oral contraceptives increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, with greater risk among older women (over 35 years of age), smokers, and females with hypertension, dyslipidaemia, diabetes, or obesity. Use of combined oral contraceptives increases the risk of venous thromboembolic events, such as deep vein thrombosis and pulmonary embolism. Based on clinical trial incidence and haemostatic profile, the risk of venous thromboembolism with NEXTSTELLIS is considered to be not higher than levonorgestrel-containing combined oral contraceptives. **Hyperkalaemia.** A theoretical risk for hyperkalaemia can be assumed only for patients whose pre-treatment serum potassium is in the upper reference range and who are additionally using potassium sparing medicines. **Hypertension.** For all women, including those with well-controlled hypertension, blood pressure should be monitored at routine visits and NEXTSTELLIS should be stopped if blood pressure rises significantly. **Bleeding patterns.** Women using NEXTSTELLIS may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first month of use, with an initial incidence of 27.1% in the first cycle and overall incidence thereafter ranging between 15% and 20% per cycle. Women who use NEXTSTELLIS may experience absence of scheduled (withdrawal) bleeding, even if not pregnant, occurring in 9.7% to 11.3% of subjects per cycle. **Depression.** Women with a history of depression should be carefully observed and NEXTSTELLIS should be discontinued if depression recurs to a serious degree.

Contraindications

Combined oral contraceptives, including NEXTSTELLIS, should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during use, the product should be stopped immediately. These include current venous thromboembolism or history of deep venous thrombosis or pulmonary embolism; known hereditary or acquired predisposition for venous thromboembolism; major surgery with prolonged immobilisation; current arterial thromboembolism or history thereof such as myocardial infarction or stroke; known hereditary or acquired predisposition for arterial thromboembolism; history of migraine with focal neurological symptoms; and high risk of arterial thromboembolism due to multiple combined risk factors or one serious risk factor such as diabetes mellitus with vascular symptoms, severe hypertension, or severe dyslipoproteinaemia. Additional contraindications include pancreatitis or history thereof if associated with severe hypertriglyceridemia; severe hepatic disease; severe renal insufficiency; liver tumours; adrenal insufficiency; known or suspected sex steroid-influenced malignancies; undiagnosed vaginal bleeding; known or suspected pregnancy; and hypersensitivity to any ingredients.

PBS listing

In March 2025, NEXTSTELLIS was recommended for Pharmaceutical Benefits Scheme listing with unrestricted benefit.

Regulatory history

NEXTSTELLIS (estetrol 14.2 mg / drospirenone 3 mg) was first registered on the ARTG on 26 November 2021. The PBAC recommended the medicine for listing in March 2025.