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Avanafil: Drug information

Avanafil: Drug information
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For additional information see "Avanafil: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Stendra
Pharmacologic Category
  • Phosphodiesterase-5 Enzyme Inhibitor
Dosing: Adult

Dosage guidance:

Safety: Do not administer in patients who regularly take nitrates due to risk for severe hypotension. After intermittent nitrate use, delay avanafil administration for ≥24 hours (Ref). If a patient taking avanafil develops chest pain, delay nitrate administration for ≥12 hours (Ref); some sources suggest waiting ≥24 hours (Ref). For patients taking a nonuroselective alpha-1 blocking antihypertensive agent, use avanafil with caution and consider a lower starting dose, as avanafil can potentiate hypotensive effects (Ref); some experts recommend against routinely using these drugs together, particularly in patients with cardiovascular disease (Ref). Use of a uroselective alpha-1 blocker in combination with avanafil is acceptable when both agents are used at low doses (Ref).

Erectile dysfunction

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.

Dosing: Kidney Impairment: Adult

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).

Dosing: Liver Impairment: Adult

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).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Stendra: 50 mg, 100 mg, 200 mg

Generic: 50 mg, 100 mg, 200 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Avanafil Oral)

50 mg (per each): $70.34

100 mg (per each): $70.34

200 mg (per each): $70.34

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.

Administration: Adult

Oral: May be administered with or without food, ~15 to 30 minutes prior to sexual activity.

Use: Labeled Indications

Erectile dysfunction: Treatment of erectile dysfunction

Medication Safety Issues
Sound-alike/look-alike issues:

Avanafil may be confused with sildenafil, tadalafil, vardenafil

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May increase hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk C: Monitor

Alpha1-Blockers (Nonselective): Phosphodiesterase 5 Inhibitors may increase hypotensive effects 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 increase hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk C: Monitor

Alprostadil: Phosphodiesterase 5 Inhibitors may increase adverse/toxic effects of Alprostadil. Risk X: Avoid

Amyl Nitrite: Phosphodiesterase 5 Inhibitors may increase vasodilatory effects of Amyl Nitrite. Risk X: Avoid

Blood Pressure Lowering Agents: Phosphodiesterase 5 Inhibitors may increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Avanafil. Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease serum concentration of Avanafil. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase 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 serum concentration of Avanafil. Risk X: Avoid

Dapoxetine: May increase orthostatic hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk X: Avoid

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Avanafil. Management: Advise patients taking avanafil to avoid consumption of grapefruit juice. In patients who continue to consume grapefruit juice, the maximum avanafil dose should not exceed 50 mg per 24-hour period. Risk D: Consider Therapy Modification

Itraconazole: May increase serum concentration of Avanafil. Risk X: Avoid

Molsidomine: May increase hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk X: Avoid

Nitroprusside: Phosphodiesterase 5 Inhibitors may increase hypotensive effects of Nitroprusside. Risk X: Avoid

Phosphodiesterase 5 Inhibitors: May increase adverse/toxic effects of Phosphodiesterase 5 Inhibitors. Risk X: Avoid

Riociguat: Phosphodiesterase 5 Inhibitors may increase hypotensive effects of Riociguat. Risk X: Avoid

Sapropterin: May increase hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk C: Monitor

Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may increase vasodilatory effects of Vasodilators (Organic Nitrates). Risk X: Avoid

Vericiguat: May increase hypotensive effects of Phosphodiesterase 5 Inhibitors. Risk X: Avoid

Food Interactions

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.).

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. This product is not indicated for use in females.

Breastfeeding Considerations

It is not known if avanafil is present in breast milk.

This product is not indicated for use in females.

Monitoring Parameters

Monitor for response, adverse reactions, blood pressure, and heart rate.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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%.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Spedra;
  • (AT) Austria: Spedra;
  • (AU) Australia: Spedra;
  • (BD) Bangladesh: Aventy;
  • (BE) Belgium: Spedra;
  • (BG) Bulgaria: Spedra;
  • (CH) Switzerland: Spedra;
  • (CZ) Czech Republic: Spedra;
  • (DE) Germany: Spedra;
  • (EE) Estonia: Spedra;
  • (EG) Egypt: Atconafil | Easyrect | Erovanafile;
  • (ES) Spain: Spedra;
  • (FI) Finland: Spedra;
  • (FR) France: Spedra;
  • (GB) United Kingdom: Spedra;
  • (GR) Greece: Spedra;
  • (HK) Hong Kong: Spedra;
  • (HR) Croatia: Spedra;
  • (HU) Hungary: Spedra;
  • (IE) Ireland: Spedra;
  • (IN) India: Avanair | Avanext;
  • (IT) Italy: Spedra;
  • (KR) Korea, Republic of: Zepeed;
  • (LT) Lithuania: Spedra;
  • (LU) Luxembourg: Spedra;
  • (LV) Latvia: Spedra;
  • (MY) Malaysia: Spedra;
  • (NG) Nigeria: Spedra;
  • (NL) Netherlands: Spedra;
  • (NO) Norway: Spedra;
  • (PL) Poland: Spedra;
  • (PR) Puerto Rico: Stendra;
  • (PT) Portugal: Spedra;
  • (RU) Russian Federation: Razatas;
  • (SA) Saudi Arabia: Vantra;
  • (SE) Sweden: Spedra;
  • (SI) Slovenia: Spedra;
  • (SK) Slovakia: Spedra;
  • (TW) Taiwan: Spedra;
  • (UA) Ukraine: Avanalav
  1. Anderson JL, Adams CD, Antman EM, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2012 ACCF/AHA focused update incorporated into the ACCF/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(23):e663-e828. doi: 10.1161/CIR.0b013e31828478ac. [PubMed 23630129] 10.1161/CIR.0b013e31828478ac
  2. Blaha MJ. Sexual activity in patients with cardiovascular disease. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 2, 2024.
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  6. Loeb S, Folkvaljon Y, Lambe M, et al. Use of Phosphodiesterase Type 5 Inhibitors for Erectile Dysfunction and Risk of Malignant Melanoma. JAMA. 2015;313(24):2449-2455. [PubMed 26103029]
  7. McVary KT, “Clinical Practice. Erectile Dysfunction,” N Engl J Med, 2007, 357(24):2472-81. [PubMed 18077811]
  8. Nehra A, Jackson G, Miner M, et al. The Princeton III Consensus recommendations for the management of erectile dysfunction and cardiovascular disease. Mayo Clin Proc. 2012;87(8):766-778. doi: 10.1016/j.mayocp.2012.06.015. [PubMed 22862865] 10.1016/j.mayocp.2012.06.015
  9. O'Gara PT, Kushner FG, Ascheim DD, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(4):e362-e425. [PubMed 23247304]
  10. Refer to manufacturer’s labeling.
  11. Stendra (avanafil) [prescribing information]. Freehold, NJ: Metuchen Pharmaceuticals LLC; October 2022.
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