estradiol valerate + medroxyprogesterone acetate: clinical use

Prescribing considerations

• Confirm that symptoms adversely affect quality of life and assess individual benefits and risks before initiation and at least annually.
• Take personal and family history and perform clinically indicated breast, pelvic and cardiovascular assessment.
• Oral combined HRT increases venous thromboembolism risk; assess thrombosis, cardiovascular, surgical and immobilisation risks.
• Investigate unexplained bleeding before treatment and new, persistent or heavy unscheduled bleeding during treatment.
• Experience in women older than 65 years is limited.

Contraindications and cautions

• Known, previous or suspected breast cancer
• Known or suspected oestrogen-dependent malignancy
• Unexplained genital bleeding or untreated endometrial hyperplasia
• Previous or current venous thromboembolism or a known thrombophilic disorder
• Active or recent arterial thromboembolic disease
• Acute liver disease, or previous liver disease while tests remain abnormal
• Porphyria or hypersensitivity to an ingredient

Monitoring

• Review symptom control, adverse effects and the benefit–risk balance periodically and at least annually.
• Monitor blood pressure and reassess breast, thrombotic, cardiovascular and liver risk as clinically indicated.
• Encourage routine breast screening and prompt reporting of breast changes.
• Assess unscheduled bleeding according to timing, persistence, severity and individual endometrial risk.
• Oestrogen can alter some laboratory measurements, including thyroid-binding proteins.

Clinical pharmacology

Estradiol valerate is absorbed orally and rapidly hydrolysed to estradiol. Medroxyprogesterone acetate is a progesterone-receptor agonist that converts oestrogen-stimulated endometrium towards a secretory state, reducing endometrial hyperplasia risk.

Formulation and product differences

• This product is a fixed oral continuous-combination tablet.
• It contains lactose monohydrate and is unsuitable in certain rare hereditary disorders of galactose or glucose-galactose handling.
• Other formulations contain different proportions of the same active ingredients; selection should follow clinical assessment rather than tablet appearance alone.

Tablet

Route: Oral

Strengths: 1 mg + 2.5 mg, 1 mg + 5 mg, 2 mg + 5 mg