dienogest: clinical use

Prescribing considerations

• Confirm pregnancy status where clinically appropriate and explain that dienogest is not contraceptive.
• Review thromboembolic, cardiovascular, hepatic, metabolic, mood and osteoporosis risk factors.
• Investigate heavy or persistent bleeding and assess for anaemia where indicated.
• Use before menarche is not indicated. Consider bone health in adolescents and people at increased osteoporosis risk.
• Review CYP3A4 inducers, inhibitors and hormonal contraception.

Contraindications and cautions

• Active venous thromboembolic disorder
• Current or previous arterial or cardiovascular disease
• Diabetes with vascular involvement
• Current or previous severe hepatic disease until liver function has normalised
• Current or previous liver tumour
• Known or suspected sex-hormone-dependent malignancy
• Undiagnosed vaginal bleeding
• Hypersensitivity to dienogest or an excipient

Monitoring

• Symptom response, tolerability and bleeding pattern
• Haemoglobin or full blood count if bleeding is heavy or persistent
• Mood, particularly with a history of depression
• Blood pressure and glycaemic control where clinically relevant
• Liver function if hepatic symptoms or deterioration occur
• Bone-health risk; consider assessment where osteoporosis risk is increased

Clinical pharmacology

Dienogest is a nortestosterone-derived progestogen with antiandrogenic activity. It suppresses endogenous oestradiol and has progestogenic effects on endometrial tissue. Oral absorption is high, and metabolism is predominantly through CYP3A4.

Formulation and product differences

• The selected product is a white, round oral tablet containing lactose monohydrate.
• People with specified rare hereditary disorders of galactose or glucose-galactose handling should not take the selected formulation.

Tablet

Route: Oral

Strengths: 2 mg