Stendra

Avanafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• flushing
• back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• an erection that lasts longer than 4 hours
• sudden loss of vision in one or both eyes (see below for more information)
• sudden hearing loss (see below for more information)
• ringing in the ears
• dizziness
• rash
• itching
• swollen eyelids

Avanafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Some patients experienced a sudden loss of some or all of their vision after they took medications that are similar to avanafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking avanafil, call your doctor immediately. Do not take any more doses of avanafil or similar medications such as sildenafil (Revatio, Viagra), tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.

Some patients experienced a sudden decrease or loss of hearing after they took other medications that are similar to avanafil. The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking avanafil, call your doctor immediately. Do not take any more doses of avanafil or similar medications such as sildenafil (Revatio, Viagra), tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.

Avanafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Avanafil is used to treat erectile dysfunction (impotence).

Avanafil may also be used for purposes not listed in this medication guide.

Taking avanafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take avanafil if you also take riociguat (Adempas) or a nitrate drug such as nitroglycerin.

Stop using avanafil and get emergency medical help if you have sudden vision loss.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

You should not take avanafil if you are allergic to it.

Taking avanafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take avanafil if you also take riociguat (Adempas), or if you take a nitrate drug for chest pain or heart problems. Nitrates include nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers").

To make sure avanafil is safe for you, tell your doctor if you have:

• heart disease or heart rhythm disorder;
• a recent history (in the past 6 months) of heart surgery;
• a history of heart attack, stroke, or life-threatening heart rhythm problem;
• congestive heart failure;
• angina (chest pain), high or low blood pressure;
• liver disease, kidney disease (or if you are on dialysis);
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• hearing or vision problems, history of vision loss;
• retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie's disease); or
• if you have been told you should not have sexual intercourse for health reasons.

Avanafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Viagra or other drugs similar to avanafil. Most of these people also had certain pre-existing eye problems or risk factors for blood vessel disorders (such as heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether avanafil is the actual cause of vision loss.

Avanafil is not for use in women. It is not known whether avanafil will harm an unborn baby.

Although avanafil is not for use in women, it is not known if this medicine passes into breast milk or if it could harm a nursing baby.

Dosage Forms & Strengths

tablets

• 50mg
• 100mg
• 200mg

Erectile Dysfunction

100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day

Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity

Use lowest effective dose

Dosage Modifications

Coadministration with strong CYP3A4 inhibitors or nitrates: Contraindicated

Coadministration with moderate CYP3A4 inhibitors: Not to exceed dose of 50 mg/24 hr

Coadministration with stable alpha-blocker therapy: Initiate therapy at 50 mg/24 hr

Renal Impairment

• Mild-to-moderate (CrCl ≥30 mL/min): Dose adjustment not necessary
• Severe impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use

Hepatic impairment

• Mild to moderate impairment: Dose adjustment not necessary
• Severe impairment: Safety and efficacy not established; do not use

Safety and efficacy not established

Do not take avanafil if you are allergic to it, or if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking avanafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of avanafil.

Do not take avanafil more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Avanafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking a similar medication called sildenafil (Viagra). Most of these people also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Stop using avanafil and get emergency medical help if you have sudden vision loss.

Your pharmacist can provide more information about avanafil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.01. Revision date: 5/14/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Stendra is a prescription medication used to treat erectile dysfunction in men. Stendra belongs to a group of drugs called phosphodiesterase (PDE) inhibitors. These work by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.

This medication comes in tablet form and is taken typically once a day, on an as needed basis, approximately 30 minutes before sexual activity. Stendra can be taken with or without food.

Common side effects of Stendra include headache, flushing, and back pain.

Serious side effects have been reported with Stendra. See the “Stendra Precautions” section.

Common side effects of Stendra include the following:

• headache
• flushing
• stuffy or runny nose
• sore throat
• back pain

This is not a complete list of Stendra side effects. Ask your doctor or pharmacist for more information.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dose range of Stendra (avanafil) is 50 mg-200 mg. For most patients, the starting dose is 100 mg taken approximately 30 minutes before sexual activity, on an as needed basis.

You should take the lowest dose of Stendra that works for you. You and your healthcare provider should decide
on the lowest dose of Stendra that works for you.

Your healthcare provider may change your dose if needed and may be based on efficacy and tolerability.

If you take too much Stendra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Stendra (avanafil) is supplied as oval, pale yellow tablets containing 50 mg, 100 mg, or 200 mg avanafil debossed with dosage strength.

Stendra was evaluated in three randomized, double-blind, placebo-controlled, parallel trials of 2 to 3 months in duration. Stendra was taken as needed at doses of 50 mg, 100 mg, and 200 mg (Study 1) and 100 mg and 200 mg (Study 2 and Study 3). Patients were instructed to take 1 dose of study drug approximately 30 minutes (Study 1 and Study 2) or approximately 15 minutes (Study 3) prior to initiation of sexual activity. Food and alcohol intake was not restricted.

In addition, a subset of patients from 2 of these trials were enrolled into an open-label extension trial. In the open-label extension trial, all eligible patients were initially assigned to avanafil 100 mg. At any point during the trial, patients could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual response to treatment.

The 3 primary outcome measures in Study 1 and 2 were the erectile function domain of the International Index of Erectile Function (IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP). The IIEF is a 4-week recall questionnaire that was administered at baseline and at 4-week intervals during treatment. The IIEF erectile function domain has a 30-point total score, where the higher scores reflect better erectile function. The SEP included diary-based measures of erectile function. Patients recorded information regarding each sexual attempt made throughout the trial. Question 2 of the SEP asks “Were you able to insert your penis into your partner’s vagina?” Question 3 of the SEP asks “Did your erection last long enough for you to have successful intercourse?”

In Study 3, the primary efficacy variable was the per-subject proportion of sexual attempts that had an erectogenic effect within approximately 15 minutes following dosing, where an erectogenic effect was defined as an erection sufficient for vaginal penetration and that enabled satisfactory completion of sexual intercourse.

Results are shown from the two, Phase 3, randomized, double-blind, placebo-controlled, parallel studies, one in the general ED population (Study 1) and the other in the diabetic population with ED (Study 2).

Results in the General ED Population (Study 1):

Stendra was evaluated in 646 men with ED of various etiologies (organic, psychogenic, mixed), in a randomized, double-blinded, parallel, placebo controlled fixed dose trial of 3 months duration. The mean age was 55.7 years (range 23 to 88 years). The population was 85.6% White, 13.2% Black, 0.9% Asian, and 0.3% of other races. The mean duration of ED was approximately 6.5 years. Stendra at doses of 50 mg, 100 mg, and 200 mg demonstrated statistically significant improvement in all 3 primary efficacy variables relative to placebo (see Table 7).

Results in the ED Population with Diabetes Mellitus (Study 2)

Stendra was evaluated in ED patients (n=390) with type 1 or type 2 diabetes mellitus in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration. The mean age was 58 years (range 30 to 78 years). The population was 80.5% White, 17.2% Black, 1.5% Asian, and 0.8% of other races. The mean duration of ED was approximately 6 years. In this trial, Stendra at doses of 100 mg and 200 mg demonstrated statistically significant improvement in all 3 primary efficacy variables as measured by the erectile function domain of the IIEF questionnaire; SEP2 and SEP3 (see Table 8).

Time to Onset of Effect (Study 3)

Stendra was evaluated in 440 subjects with ED including diabetics (16.4%) and subjects with severe ED (41.4%) in a randomized double-blind, parallel, placebo-controlled study of 2 months duration. The mean age was 58.2 years (range 24 to 86 years). The population was 75.7% White, 21.4% Black, 1.6% Asian, and 1.4% of other races. Subjects were encouraged to attempt intercourse approximately 15 minutes after dosing and used a stopwatch for measurement of time to onset of effect, defined as the time to the first occurrence of an erection sufficient for sexual intercourse.

Stendra 100 mg and 200 mg demonstrated statistically significant improvements relative to placebo in the primary efficacy variable, percentage of all attempts resulting in an erection sufficient for penetration at approximately 15 minutes after dosing followed by successful intercourse (SEP3) (see Table 9).

*comparison to placebo using rank-ANCOVA model.