Version May 2024
Note: If a patient taking avanafil develops chest pain, delay therapy with a nitrate for ≥12 hours after last avanafil dose.
Erectile dysfunction: Oral: Initial: 100 mg (or 50 mg if concurrently receiving an alpha blocker) taken ~15 minutes prior to sexual activity; taken as one single dose and not more than once daily; dose may be increased to 200 mg ~15 minutes prior to sexual activity or decreased to 50 mg ~30 minutes prior to sexual activity using the lowest dose that provides benefit; maximum 200 mg daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Use is not recommended (has not been studied).
ESRD requiring hemodialysis: Use is not recommended (has not been studied).
Mild to moderate hepatic impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe hepatic impairment (Child-Pugh class C): Use is not recommended (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Nervous system: Headache (1% to 12%)
1% to 10%:
Cardiovascular: ECG abnormality (1% to 3%), flushing (3% to 10%), hypertension (1% to 2%)
Dermatologic: Skin rash (1% to 2%)
Gastrointestinal: Constipation (1% to 2%), dyspepsia (1% to 2%), nausea (1% to 2%), viral gastroenteritis (2%)
Infection: Influenza (1% to 2%)
Nervous system: Dizziness (1% to 2%)
Neuromuscular & skeletal: Back pain (2% to 3%)
Respiratory: Bronchitis (1% to 2%), nasal congestion (≤4%), nasopharyngitis (3% to 5%), paranasal sinus congestion (1% to 2%), sinusitis (1% to 2%), upper respiratory tract infection (1% to 3%)
<1%:
Cardiovascular: Angina pectoris (including unstable angina pectoris), deep vein thrombosis, palpitations, peripheral edema
Dermatologic: Pruritus
Endocrine & metabolic: Hypoglycemia, increased serum glucose
Gastrointestinal: Gastritis, gastroesophageal reflux disease, stomach discomfort, vomiting
Genitourinary: Balanitis, hematuria, pollakiuria, prolonged erection, urinary tract infection
Hepatic: Increased serum alanine aminotransferase
Nervous system: Depression, drowsiness, fatigue, insomnia, vertigo
Neuromuscular & skeletal: Limb pain, muscle spasm, musculoskeletal pain, myalgia
Ophthalmic: Vision color changes
Renal: Nephrolithiasis
Respiratory: Cough, dyspnea on exertion, epistaxis, oropharyngeal pain, wheezing
Frequency not defined: Cardiovascular: Decreased blood pressure
Postmarketing:
Cardiovascular: Acute myocardial infarction
Nervous system: Cerebrovascular accident, subarachnoid hemorrhage, temporary amnesia
Ophthalmic: Anterior ischemic optic neuropathy (nonarteritic), visual impairment, vitreous detachment
Hypersensitivity to avanafil or any component of the formulation; coadministration with any form of organic nitrates (either regularly and/or intermittently) or guanylate cyclase stimulators (eg, riociguat, vericiguat).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Color discrimination: May cause dose-related impairment of color discrimination. Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases (no safety information available).
• Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. A direct relationship between therapy and hearing loss has not been determined.
• Hypotension: Decreases in blood pressure may occur due to vasodilator effects; use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Patients should avoid or limit concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.
• Priapism: Painful erection >6 hours in duration has been reported (rarely). Instruct patients to seek immediate medical attention if erection persists >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, leukemia).
• Vision loss: Vision loss may occur rarely and be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Instruct patients to seek medical assistance for sudden loss of vision in one or both eyes. Patients who have already experienced NAION are at an increased risk of recurrence. Other risk factors for NAION include low cup-to-disc ratio (“crowded disc”), coronary artery disease, diabetes, hypertension, hyperlipidemia, smoking, and >50 years of age. Use with caution in these patients only when the benefits outweigh the risks. Safety and efficacy were not studied in patients with known degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended.
Disease-related concerns:
• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie disease).
• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established.
• Cardiovascular disease: Use is not recommended in patients with hypotension (<90/50 mm Hg); uncontrolled hypertension (>170/100 mm Hg); unstable angina or angina during intercourse; life-threatening arrhythmias, stroke, MI, or coronary revascularization within the last 6 months; cardiac failure or coronary artery disease causing unstable angina. Safety and efficacy have not been studied in these patients. Use caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic cardiomyopathy with outflow tract obstruction). There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.
• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease; safety and efficacy have not been established.
Concurrent drug therapy issues:
• Nitrates: Use of avanafil is contraindicated in patients currently taking nitrate preparations. According to the manufacturer, when nitrate administration is deemed medically necessary in a life-threatening situation, may administer nitrates only if 12 hours has elapsed after avanafil use. Of note, the elimination half-life of avanafil is similar to that of sildenafil and vardenafil which both require 24 hours to elapse prior to administration of nitrates (ACCF/AHA [Anderson, 2013]; ACCF/AHA [O'Gara, 2013]).
Other warnings/precautions:
• Appropriate use: Potential underlying causes of erectile dysfunction should be evaluated prior to treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Stendra: 50 mg, 100 mg, 200 mg
No
Tablets (Stendra Oral)
50 mg (per each): $78.16
100 mg (per each): $78.16
200 mg (per each): $78.16
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: May be administered with or without food, ~15 to 30 minutes prior to sexual activity.
Erectile dysfunction: Treatment of erectile dysfunction
Avanafil may be confused with sildenafil, tadalafil, vardenafil
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Alpha1-Blockers (Nonselective): Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers (Nonselective). Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification
Alpha1-Blockers (Uroselective): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Alprostadil: Phosphodiesterase 5 Inhibitors may enhance the adverse/toxic effect of Alprostadil. Risk X: Avoid combination
Amyl Nitrite: Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Amyl Nitrite. Risk X: Avoid combination
Blood Pressure Lowering Agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Avanafil. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May decrease the serum concentration of Avanafil. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Avanafil. Management: The maximum avanafil dose is 50 mg per 24-hour period when used together with a moderate CYP3A4 inhibitor. Patients receiving such a combination should also be monitored more closely for evidence of adverse effects (eg, hypotension, syncope, priapism). Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Avanafil. Risk X: Avoid combination
Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Itraconazole: May increase the serum concentration of Avanafil. Risk X: Avoid combination
Lorcaserin (Withdrawn From US Market): May enhance the adverse/toxic effect of Phosphodiesterase 5 Inhibitors. Specifically, the risk of developing priapism may be increased. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Nitroprusside: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Nitroprusside. Risk X: Avoid combination
Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Riociguat: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Riociguat. Risk X: Avoid combination
Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Risk X: Avoid combination
Vericiguat: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Grapefruit juice may increase serum levels/toxicity of avanafil. Management: Monitor patients receiving this combination closely for evidence of adverse effects (eg, hypotension, syncope, priapism, etc.).
Adverse events were not observed in animal reproduction studies. This product is not indicated for use in females.
It is not known if avanafil is present in breast milk.
This product is not indicated for use in females.
Monitor for response, adverse reactions, blood pressure, and heart rate.
Does not directly cause penile erections, but affects the response to sexual stimulation. 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 cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Avanafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by avanafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum; at recommended doses, it has no effect in the absence of sexual stimulation.
Absorption: Rapid
Protein binding: ~99%
Metabolism: Hepatic via CYP3A4 (major), CYP2C (minor); forms metabolites (active and inactive)
Half-life elimination: Terminal: ~5 hours
Time to peak, plasma: 30 to 45 minutes (fasting); 1.12 to 1.25 hours (high-fat meal)
Excretion: Feces (~62%); urine (~21%)
Altered kidney function: In mild renal impairment, AUC0-inf decreased by 2.9%and Cmax increased by 2.8%; in moderate renal impairment, AUC0-inf increased by 9.1% and Cmax decreased by 2.8%.
Hepatic function impairment: In mild hepatic impairment, AUC0-inf increased by 3.8% and Cmax decreased by 2.7%; in moderate hepatic impairment, AUC0-inf increased by 11.2% and Cmax decreased by 51%.
Older adult: AUC0-inf increased by 6.8% and Cmax decreased by 2.1%.
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