avanafil: clinical use

Prescribing considerations

• Confirm erectile dysfunction and assess potentially reversible physical, psychological and medicine-related causes.
• Assess cardiovascular fitness for sexual activity, blood pressure and concurrent vasodilators.
• Review renal and hepatic function, previous serious visual events, penile anatomy and conditions predisposing to priapism.
• Use particular caution with alpha-blockers, bleeding disorders, active peptic ulceration and left ventricular outflow obstruction.

Contraindications and cautions

• Organic nitrates, nitric oxide donors or riociguat.
• Potent CYP3A4 inhibitors.
• Recent myocardial infarction, stroke or life-threatening arrhythmia.
• Resting blood pressure below 90/50 mmHg or above 170/100 mmHg.
• Unstable angina, angina during intercourse or heart failure classified as NYHA class II or greater.
• Severe renal or hepatic impairment.
• Previous vision loss from non-arteritic anterior ischaemic optic neuropathy or a hereditary degenerative retinal disorder.
• Hypersensitivity to avanafil or an excipient.

Monitoring

• No routine laboratory-monitoring programme is specified in the SmPC.
• Review effectiveness, tolerability, hypotensive symptoms and interacting medicines.
• Advise immediate assessment for priapism and prompt assessment for sudden visual or hearing symptoms.
• Suspected adverse reactions can be reported through the UK Yellow Card Scheme.

Clinical pharmacology

Avanafil is a selective, reversible PDE5 inhibitor. It is rapidly absorbed, highly protein-bound and metabolised mainly by CYP3A4, with a smaller CYP2C9 contribution. Metabolites are eliminated predominantly in faeces.

Formulation and product differences

• The selected product is a pale-yellow oval oral tablet supplied in perforated unit-dose blisters. Excipients include mannitol and yellow iron oxide, and no special storage conditions are required.

Tablet

Route: Oral

Strengths: 50 mg, 100 mg, 200 mg