Pronunciation:

a-VAN-a-fil

Brand Names:

• Stendra

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Erectile Dysfunction Agent

Pharmacologic—

Phosphodiesterase Type 5 Inhibitor

Uses of This Medicine:

Avanafil is used to treat men who have erectile dysfunction (also called sexual impotence). Avanafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, avanafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, avanafil will not work to cause an erection.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Avanafil is not indicated for use in the pediatric population. Safety and efficacy have not been established. .

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avanafil in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amyl Nitrite
• Erythrityl Tetranitrate
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Itraconazole
• Levoketoconazole
• Nitroglycerin
• Pentaerythritol Tetranitrate
• Propatyl Nitrate
• Riociguat
• Vericiguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Atazanavir
• Belzutifan
• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Dabrafenib
• Darunavir
• Duvelisib
• Efavirenz
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Idelalisib
• Indinavir
• Ivosidenib
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lopinavir
• Lorlatinib
• Mavacamten
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nirmatrelvir
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pirtobrutinib
• Posaconazole
• Primidone
• Ritlecitinib
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tocilizumab
• Trofinetide
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxazosin
• Erythromycin
• Tamsulosin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis (eg, angulation, cavernosal fibrosis, or Peyronie’s disease) or
• Leukemia (blood cancer) or
• Multiple myeloma (blood cancer) or
• Sickle-cell anemia (blood disorder)—Use with caution. May increase risk of unwanted side effects (eg, prolonged erection of the penis).

• Age greater than 50 years or
• Coronary artery disease or
• Crowded disc or low cup to disc ratio in the eye (an eye disorder) or
• Diabetes or
• Heart disease or
• Hyperlipidemia (high fats in the blood) or
• Hypertension (high blood pressure) or
• Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or
• Smoking—May increase the chance for a serious side effect in the eye called NAION.

• Angina (severe chest pain), unstable or
• Arrhythmia (irregular heartbeat, within the last 6 months) or
• Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or
• Congestive heart failure or
• Heart attack (within the last 6 months) or
• Hypertension (high blood pressure), uncontrolled or
• Hypotension (low blood pressure) or
• Retinal disorders (eye problem) or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke (within the last 6 months)—Should not be used in patients with these conditions.

• Bleeding disorders or
• Stomach ulcers—Chance of problems occurring may be increased. It is not known if the medicine is safe for use in these patients.

Proper Use of This Medicine:

Use avanafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of erectile dysfunction (as needed):
    • Adults—At first, 100 milligrams (mg) as a single dose, no more than once a day, taken 15 minutes before sexual intercourse. Your doctor may adjust your dose if needed. However, the dose is usually not more than 200 mg once a day.
    • Children—Use is not recommended.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that you tell all of your doctors that you take avanafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took avanafil.

Do not use this medicine if you are also using riociguat (Adempas®), vericiguat (Verquvo®), or a nitrate medicine, often used to treat angina (chest pain) or high blood pressure. Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® Ointment, Nitrolingual® Spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs called "poppers" (eg, amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If you need to use a nitrate medicine for emergency, take it at least 12 hours after your last dose of avanafil.

Do not take this medicine if you are also using other PDE5 inhibitors, including sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). If you take too much avanafil or take it together with these medicines, the chance for side effects will be higher.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

If you experience sudden loss of vision in one or both eyes, contact your doctor immediately.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

If you already use medicine for high blood pressure (hypertension), avanafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness.

Do not drink excessive amounts of alcohol (eg, more than 3 glasses of wine or 3 shots of whiskey) when taking avanafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

Rare

Arm, back, or jaw pain

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

chest pain, discomfort, or tightness

chest tightness or heaviness

difficult or labored breathing

difficult, burning, or painful urination

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

increased erection

lower back or side pain

nausea and vomiting

pain in the groin or genitals

pain, redness, or swelling in the arm or leg

rapid weight gain

sharp back pain just below the ribs

sweating

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Pain or discomfort in the arms, jaw, back, or neck

seeing flashes or sparks of light

seeing floating spots before the eyes, veil, or curtain appearing across part of vision

sudden decrease or loss of hearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Feeling of warmth

fever

muscle aches

redness of the face, neck, arms, and occasionally, upper chest

sore throat

stuffy or runny nose

Less common

Acid or sour stomach

belching

body aches or pain

change in color vision

chills

cough

cough producing mucus

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

ear congestion

heartburn

indigestion

joint pain

loss of appetite

loss of voice

muscle pain or stiffness

pain or tenderness around the eyes and cheekbones

rash

shivering

sneezing

sweating

trouble sleeping

Rare

Anxiety

bloody nose

bone pain

burning feeling in the chest or stomach

confusion

cool, pale skin

depression

feeling of constant movement of self or surroundings

increased hunger

itching skin

muscle aching or cramping

muscle spasms

nightmares

seizures

sensation of spinning

shakiness

sleepiness or unusual drowsiness

slurred speech

swollen joints

tenderness in the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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