dienogest + estradiol valerate: clinical use

Prescribing considerations

• Confirm that oral contraception is desired when prescribing for heavy menstrual bleeding and exclude organic pathology where appropriate.
• Assess thromboembolic history, smoking, migraine, blood pressure, body mass index, cardiovascular risk and planned immobilisation or surgery.
• Exclude pregnancy and review medicines, herbal products, unexplained bleeding, liver disease and hormone-sensitive malignancy.
• Explain thrombotic risk and symptoms requiring urgent assessment.
• Assess persistent new bleeding after previously regular cycles for pregnancy or non-hormonal pathology.

Contraindications and cautions

• Current or previous venous thromboembolism, thrombophilia, major surgery with prolonged immobilisation or otherwise high VTE risk.
• Current or previous arterial thrombosis, stroke or transient ischaemic attack, migraine with focal neurological symptoms, or high arterial-thrombotic risk.
• Severe hypertension, diabetes with vascular complications or severe dyslipoproteinaemia where these confer high arterial risk.
• Severe active liver disease, liver tumours, known or suspected sex-steroid-dependent malignancy, or unexplained vaginal bleeding.
• Hypersensitivity to an ingredient; avoid in rare hereditary disorders incompatible with the tablet’s lactose content.

Monitoring

• Measure blood pressure and document relevant medical and family history before prescribing.
• Reassess thrombotic and cardiovascular risks when circumstances change.
• Review new migraine or focal neurological symptoms, significant mood deterioration, sustained hypertension, jaundice or important bleeding changes promptly.
• Consider effects on hepatic, thyroid, adrenal, renal, lipid, carbohydrate and coagulation tests.

Clinical pharmacology

Estradiol valerate is converted to estradiol. Dienogest is a progestogen with antiandrogenic activity and is metabolised mainly through CYP3A4. Contraception chiefly results from ovulation suppression, with additional cervical-mucus and endometrial effects.

Formulation and product differences

• The wallet is multiphasic, with differently coloured active tablets containing varying hormone compositions.
• Some active tablets contain estradiol valerate alone and others contain both active ingredients; white tablets contain no active substance.
• All tablets are film-coated and contain lactose.