drospirenone + estetrol: clinical use

Prescribing considerations

• Assess personal and family history, exclude pregnancy and measure blood pressure before initiation or re-initiation.
• Evaluate venous and arterial thromboembolism risks and explain warning symptoms; the comparative VTE risk of estetrol-containing contraception remains unknown.
• Review smoking, migraine, cardiovascular risk, renal and hepatic function, planned surgery or immobilisation, mood history and interacting medicines.
• Investigate persistent irregular bleeding, bleeding after previously regular cycles or possible pregnancy as appropriate.
• This product remains subject to additional monitoring.

Contraindications and cautions

• Current or previous venous thromboembolism, thrombophilia, major surgery with prolonged immobilisation or a high combined VTE risk
• Current or previous arterial thromboembolism, stroke, transient ischaemic attack, angina or high arterial risk
• Migraine with focal neurological symptoms
• Severe hypertension, severe dyslipoproteinaemia or diabetes with vascular disease
• Severe renal insufficiency or acute renal failure
• Severe hepatic disease before liver function normalises, or current or previous liver tumour
• Known or suspected sex-steroid-sensitive breast or genital malignancy
• Unexplained vaginal bleeding
• Hypersensitivity to an ingredient

Monitoring

• Blood pressure and changes in thrombotic or cardiovascular risk factors
• Mood changes or depressive symptoms
• Bleeding pattern and adherence where pregnancy is possible
• Serum potassium with aldosterone antagonists or potassium-sparing diuretics
• Relevant renal or hepatic function when clinically indicated
• Interpret affected endocrine, metabolic, coagulation and carrier-protein laboratory tests cautiously

Clinical pharmacology

Estetrol suppresses follicle-stimulating and luteinising hormones. Drospirenone adds progestogenic and antigonadotrophic activity, with antiandrogenic and mild antimineralocorticoid effects. Inhibition of ovulation is the principal contraceptive mechanism.

Formulation and product differences

• Pink film-coated tablets contain drospirenone and estetrol; white film-coated tablets contain no active substance.
• Both active and placebo tablets contain lactose.
• The tablets are essentially sodium-free.
• The blister includes weekday stickers and uses arrows to show the tablet sequence.

Tablet

Route: Oral

Strengths: 3 mg + 14.2 mg