ospemifene: clinical use

Prescribing considerations

• Initiate only when vulval and vaginal atrophy symptoms adversely affect quality of life; reassess benefit and risk at least annually.
• Assess venous thromboembolism and cerebrovascular risk, including family history, obesity, systemic lupus erythematosus, previous stroke and anticipated immobilisation.
• Investigate other gynaecological pathology before initiation.
• Previous breast cancer requires careful specialist assessment; use should only be considered after breast-cancer treatment, including adjuvant therapy, has finished.
• Not recommended in severe hepatic impairment.

Contraindications and cautions

• Hypersensitivity to ospemifene or an excipient
• Active or previous venous thromboembolism, including retinal vein thrombosis
• Unexplained vaginal bleeding
• Suspected breast cancer or active breast-cancer treatment
• Suspected or active sex-hormone-dependent malignancy
• Signs or symptoms of endometrial hyperplasia

Monitoring

• Review continuing benefit and risk at least annually.
• Investigate vaginal bleeding or spotting occurring during treatment or persisting after discontinuation.
• Plan interruption around major surgery or prolonged immobilisation and restart only after mobility returns.
• Monitor clinical response when used with orlistat or strong enzyme inducers.

Clinical pharmacology

A nonsteroidal SERM whose parent compound and active metabolite bind oestrogen receptors, producing tissue-selective agonist and antagonist effects. It is highly protein-bound and predominantly hepatically metabolised through CYP and UGT pathways.

Formulation and product differences

• Available as a film-coated oral tablet intended to be swallowed whole with food.
• Contains lactose and is essentially sodium-free.
• The selected UK product is supplied in blister packs; not every authorised pack size may be marketed.

Tablet

Route: Oral

Strengths: 60 mg