What is the recommended dosage and treatment guidelines for avanafil (PDE5 inhibitor) in patients with erectile dysfunction (ED)?

Avanafil Dosage and Treatment Guidelines for Erectile Dysfunction

The recommended starting dose of avanafil for erectile dysfunction is 100 mg taken orally as needed approximately 15 minutes before sexual activity, with dose adjustments based on efficacy and tolerability ranging from 50 mg to 200 mg, not to exceed once daily. 1

Dosing Recommendations

• The initial recommended dose is 100 mg taken approximately 15 minutes before sexual activity 1
• Based on individual efficacy and tolerability, the dose may be:
  • Increased to 200 mg taken approximately 15 minutes before sexual activity 1
  • Decreased to 50 mg taken approximately 30 minutes before sexual activity 1
• The lowest effective dose should be used to minimize adverse effects 1
• Maximum recommended dosing frequency is once per day 1
• Avanafil may be taken with or without food 1
• Sexual stimulation is required for a response to treatment 1

Special Dosing Considerations

• For patients on stable alpha-blocker therapy, the recommended starting dose is 50 mg 1
• For patients taking moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, fluconazole), the maximum dose should be 50 mg, not to exceed once every 24 hours 1
• Avanafil should not be used with strong CYP3A4 inhibitors 1
• In patients with mild to moderate hepatic or renal impairment, use with caution at lower doses initially 2
• Avanafil is not recommended for patients with severe renal or hepatic impairment 1

Efficacy Profile

• Avanafil has similar efficacy to other PDE5 inhibitors (sildenafil, tadalafil, vardenafil) in the general ED population 2
• Onset of action is rapid, with effectiveness observed as early as 15 minutes after administration 3, 4
• Efficacy has been demonstrated for up to 6 hours after dosing 3
• Men with diabetes and post-prostatectomy patients have more severe ED at baseline and may respond less robustly to avanafil and other PDE5 inhibitors 2, 5
• Combining testosterone therapy with avanafil may improve efficacy in men with both ED and testosterone deficiency 2

Safety Profile and Adverse Effects

• Most common adverse events include headache, flushing, nasal congestion, nasopharyngitis, and back pain 2, 3
• Avanafil has the lowest rates of dyspepsia among PDE5 inhibitors 2, 6, 5
• Like tadalafil, avanafil has lower rates of myalgia compared to other PDE5 inhibitors 2, 5
• Most adverse events follow a dose-response pattern, with higher doses associated with increased rates of adverse events 2, 7

Contraindications

• Concomitant use of nitrates in any form is contraindicated due to risk of dangerous hypotension 1
• Hypersensitivity to avanafil or any component of the tablet 1
• Use with guanylate cyclase stimulators such as riociguat and vericiguat 1
• Not recommended in patients with severe hepatic or renal impairment 1

Optimizing Treatment Success

• Proper patient education is essential, as incorrect use accounts for many treatment failures 2
• Patients should be instructed that:
  • Sexual stimulation is necessary for the medication to work 2
  • More than one trial may be required to establish efficacy 2
  • The medication should be taken approximately 15 minutes before sexual activity 1
• Dose titration should be performed to balance efficacy and minimize adverse effects 2
• For patients who fail initial therapy, ensure an adequate trial was conducted (at least 5 separate occasions at maximum dose) before considering alternative treatments 2

Cardiovascular Considerations

• Cardiovascular risk should be assessed for all men with ED before prescribing avanafil 2, 5
• Sexual activity is considered equivalent to walking 1 mile in 20 minutes or climbing 2 flights of stairs in 20 seconds 2
• Men unable to perform this level of exercise without symptoms should be referred to a cardiologist before treatment 2