See Supplemental Patient Information
- Evaluate erectile dysfunction (ED) by undertaking appropriate medical assessment for identification of potential underlying causes, as well as treatment options
- Consider the cardiovascular status of patients before initiating therapy as certain degree of cardiac risk during sexual activity may exist in patients with preexisting CV disease. Avoid using therapy in men for whom sexual activity is inadvisable due to their underlying CV status. Advise patients experiencing symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention
- Patients with left ventricular outflow obstruction and those with severely impaired autonomic control of blood pressure may be extremely sensitive to the action of this drug
- Avanafil is not recommended in patients having suffered a MI, stroke, life-threatening arrhythmia, or coronary revascularization within the last 6 months and those with unstable angina, angina during sexual intercourse, New York Heart Association Class 2 or greater CHF, and resting hypotension (blood pressure <90/50 mmHg) or hypertension (blood pressure >170/100 mmHg)
- This drug is associated with mild systemic vasodilatory properties and may augment the blood pressure-lowering effect of other anti-hypertensive medications. Prior to prescribing this drug, carefully consider whether patients with underlying CV disease could be affected adversely by such vasodilatory effects, particularly during sexual activity
- Therapy is not recommended in patients receiving concomitant strong CYP3A4 inhibitors; the maximum recommended dose is 50 mg once daily for those taking concomitant moderate CYP3A4 inhibitors
- Concomitant use with alpha-blockers, other anti-hypertensives, or substantial amounts of alcohol may lead to hypotension
- Prolonged erection >4 hrs and priapism (painful erections >6 hrs in duration) may occur with this class of compounds. If priapism is not treated promptly, it may result in penile tissue damage and permanent loss of potency
- Advise patients to discontinue therapy and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should discuss about the increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of this drug. Therapy use is not recommended in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa
- Advise patients to discontinue therapy and seek prompt medical attention in the event of sudden decrease or loss of hearing; tinnitus and dizziness may also occur
- The potential for avanafil to augment the blood pressure-lowering effect of alpha-blockers and other antihypertensive medications should be discussed with the patients. Symptomatic hypotension (e.g., fainting, dizziness, lightheadedness) may occur on concomitant use of PDE5 inhibitors and alpha-adrenergic blocking agents
- Stabilize patients on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients demonstrating hemodynamic instability on alpha-blocker therapy alone are at a higher risk of symptomatic hypotension with concurrent use of PDE5 inhibitors
- In patients who are stabilized on alpha-blocker therapy, initiate PDE5 inhibitors at the lowest recommended dose
- Initiate alpha-blocker therapy at the lowest dose in patients already taking an optimized dose of PDE5 inhibitor. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure while taking a PDE5 inhibitor
- Safety of concurrent use of PDE5 inhibitors and alpha-blockers may be affected by other variables including intravascular volume depletion and other antihypertensive agents
- Inform patients that substantial consumption of alcohol (e.g., >3 units) in combination with this drug may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache
- Safety and efficacy of combinations of avanafil with other PDE5 inhibitors or ED treatments have not been established. Inform patients to avoid using avanafil with other PDE5 inhibitors
- Carefully assess risk-benefit ratio while using this drug in patients with bleeding disorders or significant active peptic ulceration
- Therapy offers no protection against sexually transmitted diseases. Consider counseling patients about the protective measures necessary to guard against STDs, including HIV
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Uncontrolled hypertension
- Aortic stenosis
- Idiopathic hypertrophic subaortic stenosis
- Coagulation disorder
- Diabetes mellitus
- Manifestations predisposing patients to priapism
- Patients with anatomical deformation of the penis
- Penile deformities
- Retinitis pigmentosa
- Degenerative retinal disorders
- History of non-arteritic anterior ischemic optic neuropathy
- Smokers
- Alcohol abuse
- Patients >50 yrs
Supplemental Patient Information
- Discuss with patients the appropriate action if they experience anginal chest pain requiring nitroglycerin following intake of avanafil; in such patients, who has taken this drug, where nitrate administration is of utmost importance for a life-threatening situation, at least 12 hrs should elapse after the last dose of avanafil before nitrate administration is considered. Under such circumstances, administer nitrates only under close medical supervision with appropriate hemodynamic monitoring. Advise patients who experience anginal chest pain after taking this drug to immediately seek medical attention
- Advise patients having an erection lasting >4 hrs, whether painful or not, to seek emergency medical attention
- Inform patients that their blood pressure may drop suddenly to an unsafe level if it is taken with certain other medicines which lower blood pressure
- Advise patients to avoid concomitant use with nitrates
- Advise patients experiencing symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention
Pregnancy Category:C
Breastfeeding: Safety unknown; avanafil is not indicated for use in women.
