Avanafilo

Avanafil

Las secciones siguientes están citadas de la ficha en inglés, porque es ese documento el que porta la autorización. Cuando una autoridad europea publica la misma información en español, el enlace figura en las fuentes. No traducimos por nuestra cuenta los textos reguladores: un error de traducción en una contraindicación sería más peligroso que una línea en otro idioma.

01Usos autorizados

• Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.

02Formas y dosis

• Avanafil tablets, 100 mg are white to off-white, oval shape, biconvex tablets debossed with 'A42' on one side and 'H' on the other side.
• Tablets: 50 mg, 100 mg, 200 mg

03Cómo se toma

• The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis
• Take avanafil tablet no more than once a day.
• Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit.
• Avanafil tablet may be taken with or without food
• Do not use avanafil tablet with strong CYP3A4 inhibitors
• If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period.

04No debe usarse en caso de

• Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated
• Hypersensitivity to any component of the avanafil tablet
• Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat

05Interacciones

• Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure

06Advertencias y precauciones

• 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 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). Avanafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION
• Patients should stop taking avanafil and seek prompt medical attention in the event of sudden decrease or loss of hearing
• Patients who have suffered a myocardial infarction, stroke, life-threatening arrhythmia, or coronary revascularization within the last 6 months;
• Patients with resting hypotension (blood pressure less than 90/50 mmHg) or hypertension (blood pressure greater than 170/100 mmHg);
• Patients with unstable angina, angina with sexual intercourse, or New York Heart Association Class 2 or greater congestive heart failure. As with other PDE5 inhibitors avanafil has systemic vasodilatory properties and may augment the blood pressure-lowering effect of other anti-hypertensive medications.

07Efectos adversos frecuentes

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

08Embarazo

Avanafil is not indicated for use in females. There are no data with the use of avanafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of avanafil during organogenesis at exposures for total avanafil at approximately 8 and 6 times, respectively, the Maximum Recommended Human Dose (MRHD) of 200 mg based on AUC (see Data).

09Mecanismo de acción

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Avanafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum.

Esta sección recoge la ficha técnica autorizada. El texto está condensado a partir del resumen de la propia autoridad, y el documento completo figura en las fuentes.