Indications

Avanafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

Composition

Pharmacology

Avanafil is a selective phosphodiesterase 5 (PDE5) enzyme inhibitor used for the treatment of erectile dysfunction caused by diabetes, age induced oxidative stress or other complications. Avanafil inhibits the cGMP specific phosphodiesterase 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum located around the penis. Penis erection during sexual stimulation is caused by increased penis blood flow resulting from the relaxation of penis arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase 5 (PDE5) by avanafil enhances erectile function by increasing the amount of cGMP.

Dosage & Administration

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.

Contraindications

Administration of Avanafil to patients using any form of organic nitrate is contraindicated. Avanafil is contraindicated in patients with a known hypersensitivity to Avanafil. Administration of Avanafil with guanylate cyclase (GC) stimulators such as riociguat and vericiguat is contraindicated.

Side Effects

Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain.

Pregnancy & Lactation

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

Precautions & Warnings

Patients should not use Avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason. Use of Avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension. Patients should seek emergency treatment if an erection lasts greater than 4 hours. Patients should stop taking Avanafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non-Arteritic Ischemic Optic Neuropathy (NAION). Discuss with patients the increased risk of NAION in patients with a prior history of NAION. Patients should stop taking Avanafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

Therapeutic Class

Drugs for Erectile Dysfunction

Storage Conditions

Store below 25°C temperature. Keep away from light and wet place. Keep out of reach of children.