VISANNE

What it is

Visanne contains 2 mg of dienogest per tablet. Dienogest is a norgestosterone derivative with antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest has no significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

Approved indications

— Treatment of endometriosis.

Dosing overview

The dosage of dienogest is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.

Key safety warnings

The efficacy of dienogest may be reduced in the event of missed tablets, vomiting and/or diarrhoea if occurring within 3–4 hours after tablet taking. In women with a history of extrauterine pregnancy or an impairment of tube function, the use of dienogest should be decided on only after carefully weighing the benefits against the risks. The risk of cardiovascular and cerebral events is related to increasing age, hypertension, and smoking. In case of long-term immobilisation it is advisable to discontinue the use of dienogest (in the case of elective surgery at least four weeks in advance) and not to resume treatment until two weeks after complete remobilisation. Treatment should be stopped at once if there are symptoms or suspicion of an arterial or venous thrombotic event. Uterine bleeding, for example in women with adenomyosis or uterine leiomyomata, may be aggravated with the use of dienogest. If bleeding is heavy and continuous over time this may lead to anaemia (severe in some cases). In the event of anaemia, discontinuation of dienogest should be considered. In patients who are at an increased risk of osteoporosis a careful risk-benefit assessment should be performed before starting dienogest because endogenous oestrogen levels are moderately decreased during treatment with dienogest. The use of dienogest in adolescents (12 to <18 years) over a treatment period of 12 months was associated with a mean decrease in bone mineral density (BMD) in the lumbar spine of 1.2%. Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

Contraindications

Dienogest should not be used in the presence of known or suspected pregnancy or lactation. Active venous thromboembolic disorder or arterial and cardiovascular disease, present or in history (for example myocardial infarction, cerebrovascular accident, ischaemic heart disease) are contraindications. Severe hepatic disease (present or in history) as long as liver function values have not returned to normal, liver tumours (benign or malignant), known or suspected sex hormone-dependent malignancies, and undiagnosed vaginal bleeding are contraindications. Hypersensitivity to the active substance or to any of the excipients is also a contraindication.

PBS listing

Visanne 2 mg tablets are listed on the PBS with one item under streamlined restriction. The ex-manufacturer price is A$41.15.

Regulatory history

Visanne was approved by the TGA on 25 May 2010 for the treatment of endometriosis. The product was first listed on the Australian Register of Therapeutic Goods on 11 June 2010.