SLINDA

What it is

Slinda is a tablet containing drospirenone. Each active tablet contains 4 mg of drospirenone. Slinda is a progestogen-only pill which contains the progestogen drospirenone, derived from spironolactone. In a therapeutic dosage, drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. This gives drospirenone a pharmacological profile closely resembling the natural hormone progesterone.

Approved indications

— Contraception.

Dosing overview

One tablet is to be taken daily for 28 consecutive days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. Tablets must be taken every day, at about the same time of the day, so that the interval between two tablets is always 24 hours.

Key safety warnings

Drospirenone is an aldosterone antagonist with potassium sparing properties. In most cases, no increase of potassium levels is to be expected. However, it is recommended to check serum potassium levels during the first treatment cycle in patients presenting with renal insufficiency and pre-treatment serum potassium in the upper reference range, and during concomitant use of potassium sparing medicinal products. From epidemiological studies there is little evidence for an association between progestogen-only preparations and an increased risk of myocardial infarction or cerebral thromboembolism. Rather, the risk of cardiovascular and cerebral events is related to increasing age, hypertension, and smoking. In patients with hypertension the risk of stroke may be slightly enhanced by progestogen-only preparations. Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof and discontinuation of Slinda should be considered in case of prolonged immobilisation due to surgery or illness. Treatment with Slinda leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is currently unknown whether the decrease in estradiol serum levels may have a clinically relevant effect on bone mineral density. Loss of bone mineral density is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if bone mineral density decrease in this population will reduce peak bone mass and increase the risk for fracture in later life. Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Patients should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.

Contraindications

Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Severe renal insufficiency or acute renal failure. Known or suspected sex-steroid sensitive malignancies. Undiagnosed vaginal bleeding. Known or suspected pregnancy. Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients.

PBS listing

Slinda was recommended for General Schedule unrestricted benefit listing in November 2024 for contraception.

Regulatory history

Slinda received initial approval on 5 July 2021. The product is registered on the ARTG under licence category RE (Registered Export). In November 2024, the PBAC recommended Slinda for unrestricted general schedule listing.