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) 08/2017

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 Neuropathy (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: 12/2016

Important Safety Information

What is the most important information you should know about STENDRA?

STENDRA® (avanafil) is a prescription medicine used to treat erectile dysfunction (ED).

STENDRA is not for use in women or children. It is not known if STENDRA is safe or effective in women or children under 18 years of age.

Important Safety Information

What is the most important information you should know about STENDRA?

STENDRA® (avanafil) is a prescription medicine used to treat erectile dysfunction (ED).

STENDRA is not for use in women or children. It is not known if STENDRA is safe or effective in women or children under 18 years of age.

Do not take STENDRA if you take any medicines called “nitrates” or “guanylate cyclase stimulators”, as these combinations can cause your blood pressure to drop suddenly to unsafe levels. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Tell all of your healthcare providers that you take STENDRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took STENDRA.

Stop sexual activity and get medical help right away if you experience symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Who should not take STENDRA?

Do not take STENDRA if you:

  • take nitrates, often prescribed for chest pain (angina), as this may cause a sudden, unsafe drop in blood pressure
  • take guanylate cyclase stimulators such as riociguat (Adempas®), which are often used to treat pulmonary hypertension
  • take street drugs called “poppers” such as amyl nitrate and butyl nitrate
  • are allergic to STENDRA (avanafil) or any of the ingredients in STENDRA. Seek medical attention right away if you experience any symptoms of an allergic reaction such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

Before you take STENDRA, tell your healthcare provider if you:

  • have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure
  • have had heart surgery within the last 6 months
  • have pulmonary hypertension
  • have had a stroke
  • have low blood pressure, or high blood pressure that is not controlled
  • have a deformed penis shape
  • have had an erection that lasted for more than 4 hours
  • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • have ever had severe vision loss, including an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION)
  • have bleeding problems
  • have or have had stomach ulcers
  • have liver problems
  • have kidney problems or are having kidney dialysis
  • have any other medical condition

STENDRA may affect the way other medicines work.

Tell your healthcare provider about all medicines you take, including any of the following:

  • medicines called nitrates
  • medicines called guanylate cyclase stimulators such as riociguat (ADEMPAS)
  • medicines called HIV protease inhibitors such as ritonavir (NORVIR), indinavir (CRIXIVAN), saquinavir (FORTAVASE or INVIRASE) or atazanavir (REYATAZ)
  • some types of oral antifungal medicines, such as ketoconazole (NIZORAL) and itraconazole (SPORANOX)
  • some types of antibiotics, such as clarithromycin (BIAXIN), telithromycin (KETEK), or erythromycin
  • medicines called alpha-blockers. These include HYTRIN (terazosin), FLOMAX (tamsulosin HCl), CARDURA (doxazosin), MINIPRESS (prazosin HCl), UROXATRAL (alfuzosin HCl), JALYN (dutasteride and tamsulosin HCl), or RAPAFLO (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or to fainting
  • other medicines that treat high blood pressure
  • other medicines or treatments for ED

Do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking STENDRA can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What are the possible side effects of STENDRA?

The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.

Rare but serious side effects of STENDRA may include:

  • an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away
  • sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called nonarteritic anterior ischemic optic neuropathy (NAION). Stop if you have sudden vision loss in one or both eyes
  • sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness

STENDRA does not protect against pregnancy or sexually transmitted diseases, including HIV.

How should I take STENDRA?

  • The starting dose of STENDRA is 100 mg taken as early as approximately 15 minutes before sexual activity.
  • The dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken as early as approximately 30 minutes before sexual activity. The lowest effective dose should be used.
  • STENDRA may be taken with or without food.
  • Moderate consumption of alcohol is allowed (up to 3 drinks). Do not take more than 3 drinks (e.g. 3 glasses of wine or 3 shots of whiskey) when taking STENDRA.
  • Sexual stimulation is required for an erection to occur after taking STENDRA.
  • Do not take STENDRA more than once per day.
  • The safety and efficacy of combinations of STENDRA with other treatments for ED has not been studied. Therefore, the use of such combinations is not recommended.

USE ONLY AS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL

These are not all the possible side effects of STENDRA. Talk to your healthcare provider or pharmacist for more information or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch.

For more dosing information, please see accompanying full Prescribing Information and Patient Information.

Reference: 1. Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007;120(2): 151-157.