Avanafil is indicated for the treatment of erectile dysfunction in adult men.

Avanafil is a selective phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction resulting from conditions such as diabetes, aging, or other underlying causes. It works by inhibiting the PDE5 enzyme, which normally breaks down cyclic guanosine monophosphate (cGMP) in the corpus cavernosum of the penis. During sexual stimulation, nitric oxide (NO) is released from nerve endings and endothelial cells, stimulating the production of cGMP. Increased cGMP levels lead to relaxation of smooth muscles and dilation of penile blood vessels, enhancing blood flow and resulting in erection. By preventing the breakdown of cGMP, Avanafil enhances and prolongs the erectile response.

The recommended starting dose is 100 mg taken approximately 15 minutes before sexual activity, on an as needed basis. Avanafil may be taken with or without food. Avanafil must not be taken more than once a day. The dose may be increased to 200 mg or decreased to 50 mg based on efficacy and/or tolerability. Use the lowest dose that provides benefit. Concomitant use of nitrates in any form is contraindicated. Do not use Avanafil with strong CYP3A4 inhibitors. If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period. In patients on stable alpha-blocker therapy, the recommended starting dose of Avanafil is 50 mg.

Avanafil may enhance the blood pressure–lowering effects of nitrates, alpha-blockers, antihypertensive agents, and alcohol. Co-administration with CYP3A4 inhibitors (such as ketoconazole, ritonavir, and erythromycin) can increase Avanafil plasma concentration and exposure.

Avanafil is contraindicated in patients taking any form of organic nitrates. It is also contraindicated in patients with known hypersensitivity to Avanafil. Concurrent use with guanylate cyclase (GC) stimulators such as riociguat or vericiguat is contraindicated.

Common adverse effects (≥2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain.

Pregnancy Category C. Avanafil is not intended for use in women.

Avanafil should not be used in patients for whom sexual activity is not recommended due to cardiovascular or other health conditions.

Use with alpha-blockers, antihypertensive agents, or excessive alcohol intake (more than 3 units) may lead to symptomatic hypotension.

Patients should seek immediate medical attention if an erection persists for more than 4 hours.

Sudden vision loss in one or both eyes may indicate non-arteritic ischemic optic neuropathy (NAION); discontinue use and seek medical care. Patients with a history of NAION may have increased risk.

Sudden decrease or loss of hearing also requires immediate discontinuation and medical evaluation.

Pediatric use: Not indicated

Geriatric use: No dose adjustment required, but increased sensitivity may occur

Renal & hepatic impairment: Avoid use in severe impairment

Single doses up to 800 mg and repeated doses up to 300 mg have been studied. In overdose, supportive treatment should be provided. Hemodialysis is unlikely to be effective due to high protein binding and minimal renal excretion.

Drugs for erectile dysfunction.

Store below 25°C, protected from light and moisture. Keep out of reach of children.