HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA. STENDRA® (avanafil) tablets, for oral use.

Initial U.S. Approval: 2012

RECENT MAJOR CHANGES

Warnings and Precautions, Effects on the Eye (5.4) 04/2014

Dosage and Administration (2.1) 09/2014

Contraindications, Concomitant Guanylate Cyclase (GC)

Stimulators (4.3) 09/2015

INDICATIONS AND USAGE

STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (1)

DOSAGE AND ADMINISTRATION

  • The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis (2.1)
  • Take STENDRA no more than once a day (2.1)
  • Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or
    decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit (2.1)
  • STENDRA may be taken with or without food (2.2)
  • Do not use STENDRA with strong CYP3A4 inhibitors (2.3)
  • If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period (2.3)
  • In patients on stable alpha-blocker therapy, the recommended starting dose of STENDRA is 50 mg (2.3)

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg, 100 mg, 200 mg (3)

CONTRAINDICATIONS

  • Administration of STENDRA to patients using any form of organic nitrate is contraindicated (4.1)
  • Hypersensitivity to any component of the STENDRA tablet (4.2)
  • Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3)

WARNINGS AND PRECAUTIONS

  • Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason (5.1)
  • Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension (2.3, 5.6, 5.7)
  • Patients should seek emergency treatment if an erection lasts greater than 4 hours (5.3)
  • Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic
    europathy (NAION). STENDRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
    Patients with a “crowded” optic disc may also be at an increased risk of NAION (5.4, 6.2)
  • Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5)

ADVERSE REACTIONS

Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact 866.928.6180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

  • STENDRA can potentiate the hypotensive effect of nitrates, alphablockers, antihypertensives, and alcohol (7.1)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure (7.2)

USE IN SPECIFIC POPULATIONS

  • Do not use in patients with severe renal impairment (8.6)
  • Do not use in patients with severe hepatic impairment (8.7)
  • See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling Revised: 06/2016