Aventy 100

Erectile Dysfunction

May take with or without food

Erectile Dysfunction 100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity Use lowest effective dose Hepatic impairment Mild to moderate impairment: Dose adjustment not necessary Severe impairment: Safety and efficacy not established; do not use

Renal Impairment Mild-to-moderate (CrCl ?30 mL/min): Dose adjustment not necessary Severe impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use

Hypersensitivity Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

Sexual stimulation causes nitric oxide to be released in the corpus cavernosum; nitric oxide activates the enzyme guanylate cyclase, which in turn increases cGMP levels; increase in cGMP levels causes smooth muscle relaxation. Phosphodiesterase type 5 inhibitors enhance the effects of nitric oxide in smooth muscle relaxation of the corpus cavernosum by inhibiting the degradation of cGMP.

Potential for cardiovascular risk during sexual activity in patients with underlying cardiovascular conditions Monitor patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) Dose should not exceed 50 mg/24hr when taking avanafil concomitantly with moderate CYP3A4 inhibitors Initiate therapy at 50 mg/24hr if coadministered with antihypertensive medications like alpha-blockers Priapism may occur especially in patients with predisposed conditions (eg, sickle cell anemia, multiple myeloma, or leukemia) Discontinue therapy if sudden loss of vision in one or both eyes occur (could be a sign of non-arteritic anterior ischemic optic neuropathy) Safety and efficacy not established in patients with hereditary retinal disorders, including retinitis pigmentosa (use not recommended) Sudden hearing loss may occur; discontinue therapy if tinnitus symptoms occur Alcohol may increase risk for orthostatic hypotension; may increase heart rate and cause dizziness and headache Lactation: Safety and efficacy not established

>2% Headache (5.6%) Flushing (3.5%) Nasal congestion (2.1%) Nasopharyngitis (3.4%) Back pain (2.5%) Upper respiratory infection (<2%) Bronchitis (<2%) Influenza (<2%) Sinusitis (<2%) Sinus congestion (<2%) Hypertension (<2%) Dyspepsia (<2%) Nausea (<2%) Constipation (<2%) Rash (<2%) <1% Peripheral edema Fatigue Angina Deep vein thrombosis Palpitations Gastritis Gastroesophageal reflux disease Hypoglycemia Hyperglycemia Oropharyngeal pain Stomach discomfort Vomiting Depression Insomnia Cough Dyspnea exertional Epistaxis Wheezing Pruritus Urinary tract infection Pollakiuria Nephrolithiasis Hematuria Increased erection Balanitis

Pregnancy Category: C Lactation: Safety and efficacy not established