estradiol hemihydrate + nomegestrol acetate: clinical use

Prescribing considerations

• Assess current and family thromboembolic history, smoking, migraine, cardiovascular risks, planned surgery or immobilisation, and interacting medicines.
• Exclude pregnancy and measure blood pressure before initiation or re-initiation.
• Discuss bleeding-pattern changes, including possible absent withdrawal bleeding.
• Safety and efficacy are not established in adolescents under 18 years.

Contraindications and cautions

• Current, previous or high risk of venous or arterial thromboembolism
• Migraine with focal neurological symptoms
• Severe hypertension, vascular diabetes or severe dyslipoproteinaemia
• Severe liver disease, liver tumour or pancreatitis associated with severe hypertriglyceridaemia
• Known or suspected sex-steroid-sensitive malignancy
• Meningioma or a history of meningioma
• Unexplained vaginal bleeding
• Hypersensitivity to an ingredient

Monitoring

• Reassess blood pressure and evolving thrombotic risk factors.
• Review new or worsening migraine, depression, persistent bleeding disturbance or liver dysfunction.
• Monitor for symptoms suggesting meningioma; stop nomegestrol-containing treatment if meningioma is diagnosed.
• Consider relevant monitoring when interacting medicines, particularly lamotrigine, are started or stopped.

Clinical pharmacology

Nomegestrol acetate is a selective progesterone-receptor agonist with antigonadotrophic and anti-oestrogenic activity. Estradiol is chemically identical to endogenous 17β-estradiol. Contraception primarily results from ovulation inhibition and altered cervical secretion.

Formulation and product differences

• The blister contains white active hormone tablets and yellow placebo tablets.
• Both tablet types contain lactose monohydrate.
• The tablets are film-coated and intended for oral use.

Tablet

Route: Oral

Strengths: 2.5 mg + 1.5 mg