Patient Information Stendra®

(sten-druh) (avanafil) Tablets

Read this Patient Information before you start taking STENDRA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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

STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take STENDRA if you take any medicines called “nitrates.” Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take STENDRA if you take medicines called guanylate cyclase stimulators which include:

  • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension

Ask your healthcare provider or pharmacist if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

Tell all 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 get 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.

What is STENDRA?

STENDRA 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 and effective in women or children under 18 years of age.

Who should not take STENDRA?

Do not take STENDRA if you:

  • Take medicines called “nitrates”
  • Use street drugs called “poppers” such as amyl nitrate and butyl nitrate
  • Are allergic to avanafil or any of the ingredients in STENDRA. See the end of this leaflet for a complete list of ingredients in STENDRA.
  • Take any medicines called guanylate cyclase stimulators, such as riociguat. What should I tell my healthcare provider before taking STENDRA?

What should I tell my healthcare provider before taking STENDRA?

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 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 non-arteritic 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 conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works causing side effects. Especially tell your healthcare provider if you take any of the following:

  • Medicines called nitrates (see What is the most important information I should know about STENDRA?)
  • Medicines called guanylate cyclose stimulators, such a riociguat (see What is the most important information I should know about STENDRA?)
  • Medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir (Crixivan), saquinavir (Fortavase or Invirase) or atazanir (Reyataz)
  • Some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (Sporonox)
  • Some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
  • Medicines called alpha blockers. These include Hytrin (terazosin), Flomax (tamsulosin HC1), Cardura (doxazosin), Minipress (prazosin HC1), Uroxatral (alfuzosin HC1), Jalyn (dutasteride and tamsulosin HC1), 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

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take STENDRA?

  • Take STENDRA exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much STENDRA to take and when to take it.
  • Take STENDRA 100 mg or 200 mg as early as approximately 15 minutes before sexual activity.
  • Take STENDRA 50 mg as early as approximately 30 minutes before sexual activity
  • Do not take STENDRA more than 1 time a day.
  • Your healthcare provider may change your dose if needed.
  • You should take the lowest dose of STENDRA that works for you. You and your healthcare provider should decide about the lowest dose of STENDRA that works for you.

STENDRA may be taken with or without food.

  • Do not drink too much alcohol when taking STENDRA (for example, 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
  • Back pain

STENDRA may uncommonly cause:

  • 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 1 or both eyes. Sudden vision loss in 1 or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in 1 or both eyes.
  • Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store STENDRA?

  • Store STENDRA at 68°F to 77°F (20°C to 25°C).
  • Keep STENDRA out of the light.

Keep STENDRA and all medicines out of the reach of children General information about the safe and effective use of STENDRA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use STENDRA for a condition for which it was not prescribed. Do not give STENDRA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about STENDRA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about STENDRA that is written for health professionals.

For more information, go to www.STENDRA.com or call 1-844-458-4887.

What are the ingredients in STENDRA?

Active ingredient: avanafil

Inactive ingredients: mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate, and ferric

oxide yellow

This Patient Information has been approved by the U.S. Food and Drug Administration.

Norvir (ritonavir) is a trademark of Abbott Laboratories

Crixivan (indinavir sulfate) is a trademark of Merck Sharp & Dohme Coip.

Invirase (saquinavir mesylate) is a trademark of Hoffmann-1. A Roche, Inc.

Reyataz (atazanavir sulfate) is a trademark of Bristol-Myers Squibb Co.

Biaxin (clarithromycin) is a trademeark of Abbott Laboratories Ketek (telithromycin) is a trademark of Aventis Pharma S.A.

Nizoral (ketoconazole) is a trademark of Johnson & Johnson

Sporanox (itraconazole) is a trademark of Johnson & Johnson

Hytrin (terazosin HC1) is a trademark of Abbott Laboratories

Flomax (tamsulosin HC1) is a trademark of Yamanouchi Pharmaceutical Co., Ltd.

Cardura (doxazosin mesylate) is a trademark of Pfizer Inc.

Minipress (prazosin HC1) is a trademark of Pfizer Inc.

Uroxatral (alfuzosin HC1) is a trademark of Sanofi Societi Anonyme France Jalyn (dutasteride and tamsulosin HC1) is a trademark of Glaxo Group Limited Rapaflo (silodosin) is a trademark of Watson Pharmaceuticals, Inc.

Manufactured for: Mist Pharmaceuticals, LLC, Cranford, NJ 07016 By: Sanofi Winthrope Industrie, Ambares, France;

© Metuchen Pharmaceuticals, LLC. All rights reserved.

US Patent Number: 6,656,935 and 7,501,409

STENDRA is a registered U.S. trademark of Metuchen Pharmaceuticals, LLC. 332F001

Important Safety Information

Important Safety Information

INDICATION

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

IMPORTANT SAFETY INFORMATION ABOUT STENDRA

  • Administration of STENDRA with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. STENDRA has been shown to potentiate the hypotensive effects of nitrates.
  • STENDRA is contraindicated in patients with a known hypersensitivity to any component of the tablet.
  • Do not use STENDRA in patients who are using a Guanylate Cyclase (GC) stimulator, such as riociguat. PDE 5 inhibitors, including STENDRA may potentiate the hypotensive effects of GC stimulators
  • There is a potential for cardiac risk during sexual activity in patients with preexisting cardiovascular disease. Patients should therefore not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason.
  • Patients with the following characteristics (recent serious cardiovascular events, resting hypotension or uncontrolled hypertension, unstable angina, angina with sexual intercourse, New York Heart Association Class 2 or greater congestive heart failure, or hereditary degenerative retinal disorders, including retinitis pigmentosa) were not included in the clinical safety and efficacy trials. STENDRA is therefore not recommended for those patients.
  • As with other PDE5 inhibitors, STENDRA has systemic vasodilatory properties and may augment the blood pressure-lowering effect of other antihypertensive medications. Physicians should carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.
  • STENDRA metabolism is principally mediated by the CYP450 isoform 3A4 (CYP3A4). Inhibitors of CYP3A4 may reduce STENDRA clearance and increase plasma concentrations of avanafil. Do not use STENDRA in patients taking concomitant strong CYP3A4 inhibitors. For patients taking concomitant moderate CYP3A4 inhibitors, the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours.
  • Prolonged erections greater than 4 hours in duration and priapism (painful erections greater than 6 hours in duration) have been reported with other PDE5 inhibitors. Patients should seek emergency treatment for an erection that lasts longer than 4 hours. If not treated immediately, penile tissue damage and permanent loss of potency could result. Use with caution in patients with anatomical deformation of the penis or in patients with conditions that may predispose them to priapism.
  • Physicians should advise patients to stop use of all PDE5 inhibitors, including STENDRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. This may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision. STENDRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
  • Use of PDE5 inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Patients experiencing these symptoms should be advised to stop taking STENDRA and seek prompt medical attention.
  • Physicians should discuss with patients the potential for STENDRA to augment the blood pressure-lowering effect of alpha-blockers and other antihypertensive medications.
  • Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating treatment with a PDE5 inhibitor. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose (STENDRA 50 mg). In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dosage may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
  • Both alcohol and PDE5 inhibitors including STENDRA act as vasodilators. When vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Physicians should therefore inform patients that substantial consumption of alcohol (ie, greater than 3 units) in combination with STENDRA may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
  • The safety and efficacy of combinations of STENDRA with other treatments for ED have not been studied. The use of such combinations is therefore not recommended.
  • The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration. In vitro studies with human platelets indicate that STENDRA potentiates the anti-aggregatory effect of sodium nitroprusside (a nitric oxide [NO] donor).
  • The use of STENDRA offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV), should be considered.
  • The most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain.
  • Drug interactions: STENDRA can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol. CYP3A4 inhibitors (eg, ketoconazole, ritonavir, erythromycin) increase STENDRA exposure.

Please see full Prescribing Information.

References: 1. STENDRA [package insert]. Mist Pharmaceuticals.; 2015. 2. Viagra® [package insert]. Pfizer Inc; 2015. 3. Levitra® [package insert]. Bayer Healthcare Pharmaceuticals Inc.; 2015. 4. Staxyn® [package insert]. Bayer Healthcare Pharmaceuticals Inc.; 2015. 5. Cialis® [package insert]. Eli Lilly and Company; 2016. 6. Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012; 9(4):1122-1133. 7. Goldstein I, Jones LA, Belkoff LH, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012; 87(9):843-852. 8. Data on File. Clinical Study Report. Mist Pharmaceuticals.; 2014. 9. Mulhall JP, Burnett AL, Wang R, et al. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013; 189(6):2229-2236. 10. Belkoff LH, McCullough A, Goldstein I, et al. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013;67(4):333-341.