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STENDRA™ (avanafil) is indicated for the treatment of erectile dysfunction (ED).
The use of STENDRA and organic nitrates in any form, at any time, is contraindicated.
Before treating ED, physicians should consider the impact of resuming sexual activity and the mild and transient vasodilatory effects of STENDRA on blood pressure. Physicians should carefully consider whether patients with underlying cardiovascular disease or other more unusual conditions could be adversely affected by vasodilatory effects, especially in combination with sexual activity.
For patients taking concomitant strong CYP3A4 inhibitors (including anti-fungals ketoconazole, itraconazole; protease inhibitors for HIV: ritonavir, atazanavir, indinavir, nelfinavir, saquinavir; antibiotics clarithromycin and telithromycin; and the antidepressant nefazodone), use of STENDRA is not recommended.
As there have been infrequent reports of prolonged erections lasting more than 4 hours or priapism with all ED treatments in this drug class, patients should be advised to seek immediate medical attention should these occur. Erections lasting longer than 6 hours can result in penile tissue damage and long-term loss of potency.
Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including STENDRA, and seek medical attention in the event of sudden loss of vision.
Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should advise patients to stop taking PDE5 inhibitors, including STENDRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Physicians should advise patients of the potential for PDE5 inhibitors, including STENDRA, to augment the blood pressure lowering effect of alpha blockers and anti-hypertensive medications. In some patients concomitant administration of a PDE5 inhibitor and alpha blocker may lead to symptomatic hypotension. Patients should be stable on alpha-blocker therapy prior to taking STENDRA.
Patients should be made aware that both alcohol and PDE5 inhibitors including STENDRA act as vasodilators. When vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Physicians should inform patients that substantial consumption of alcohol (e.g., greater than 3 units) in combination with STENDRA may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness and headache.
Physicians should inform patients not to take STENDRA with other PDE5 inhibitors as the safety and efficacy of these combinations have not been studied.
Use of STENDRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.
The most common side effects of STENDRA were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%).