Avanafil

Name: Avanafil

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Avanafil Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

During sexual activity, if you become dizzy or nauseated, or 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.

Stop using avanafil and call your doctor at once if you have:

  • vision changes, sudden vision loss;
  • ringing in your ears, or sudden hearing loss;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • pain, swelling, warmth, or redness in one or both legs;
  • shortness of breath, swelling in your hands or feet;
  • a light-headed feeling, like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

  • headache;
  • flushing (warmth, redness, or tingly feeling);
  • cold symptoms such as runny or stuffy nose, sore throat; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Reviewed on 2/26/2015 References REFERENCE: FDA Prescribing Information

Side Effects of Avanafil

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

Common side effects of avanafil include the following:

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

This is not a complete list of avanafil 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.

Other Requirements

  • Store avanafil at 68°F to 77°F (20°C to 25°C).
  • Store avanafil out of the light.
  • Keep this and all medicines out of the reach of children.

What is avanafil?

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.

How should I take avanafil?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Avanafil can be taken with or without food.

Avanafil is usually taken only when needed, about 30 minutes before sexual activity. Follow your doctor's instructions.

Avanafil can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.

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.

Store at room temperature away from moisture, heat, and light.

What should I avoid while taking avanafil?

Drinking alcohol can increase certain side effects of avanafil. Avoid drinking more than 3 alcoholic beverages while you are taking avanafil.

Grapefruit and grapefruit juice may interact with avanafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking avanafil.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Avanafil dosing information

Usual Adult Dose for Erectile Dysfunction:

Initial dose: 100 mg orally as needed approximately 30 minutes before sexual activity.
Maintenance dose: 50 to 200 mg orally as needed 30 minutes before sexual activity.
Maximum dose: 200 mg orally once a day

Comments:
-The lowest dose that provides benefit should be taken.
-Sexual stimulation is needed for a response to treatment.

Use: Treatment of erectile dysfunction

Stability

Storage

Oral

Tablets

20–25°C (may be temporarily exposed to ≤30°C).1 5 Protect from light.1 5

Commonly used brand name(s)

In the U.S.

  • Stendra

Available Dosage Forms:

  • Tablet

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Before Using avanafil

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 avanafil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to avanafil 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.

Pediatric

Avanafil is not indicated in children .

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 avanafil, 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 avanafil 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
  • Nitroglycerin
  • Pentaerythritol Tetranitrate
  • Propatyl Nitrate
  • Riociguat

Using avanafil 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.

  • Atazanavir
  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Efavirenz
  • Etravirine
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Voriconazole

Using avanafil 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

Interactions with Food/Tobacco/Alcohol

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 avanafil 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 avanafil, 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 avanafil. 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—Chance of problems occurring may be increased and avanafil should be used with caution in these patients.
  • 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.
  • Leukemia (blood related cancer) or
  • Multiple myeloma (blood related cancer) or
  • Sickle-cell anemia (blood disorder)—Avanafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.

What are some things I need to know or do while I take Avanafil?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how avanafil affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Do not take this medicine with other drugs used to treat a change in sex ability.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • Talk with your doctor before you drink alcohol.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • A very bad eye problem has rarely happened with avanafil. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
  • This medicine is not approved for use in children. Talk with the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about avanafil, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about avanafil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using avanafil.

Review Date: October 4, 2017

Brand Names U.S.

  • Stendra

Pharmacologic Category

  • Phosphodiesterase-5 Enzyme Inhibitor

Special Populations Elderly

AUC0-inf increased by 6.8% and Cmax decreased by 2.1%.

Dosing Adult

Erectile dysfunction: Oral: Initial: 100 mg taken ~15 minutes prior to sexual activity; taken as one single dose and not more than once daily; dose may be increased to 200 mg ~15 minutes prior to sexual activity or decreased to 50 mg ~30 minutes prior to sexual activity using the lowest dose that provides benefit; maximum 200 mg daily

Dosing adjustment with concomitant medications:

Alpha-blocker (dose should be stable at time of avanafil initiation): Initial avanafil dose: 50 mg taken as one single dose and not more than once daily.

Moderate CYP34A inhibitors (including amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil): Maximum avanafil dose: 50 mg taken as one single dose and not more than once daily.

Strong CYP3A4 inhibitors (including atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, saquinavir, ritonavir, telithromycin): Avoid concomitant use of avanafil.

Dosing Geriatric

Elderly ≥65 years: Refer to adult dosing.

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

STENDRA was administered to 2215 men during clinical trials. In trials of STENDRA for use as needed, a total of 493 patients were exposed for greater than or equal to 6 months, and 153 patients were treated for greater than or equal to 12 months.

In three randomized, double-blind, placebo-controlled trials lasting up to 3 months in duration, the mean age of patients was 56.4 years (range from 23 to 88 years). 83.9 % of patients were White, 13.8% were Black, 1.4% Asian, and < 1% Hispanic. 41.1% were current or previous smokers. 30.6% had diabetes mellitus.

The discontinuation rate due to adverse reactions for patients treated with STENDRA 50 mg, 100 mg, or 200 mg was 1.4%, 2.0%, and 2.0%, respectively, compared to 1.7% for placebo-treated patients.

Table 1 presents the adverse reactions reported when STENDRA was taken as recommended (on an as-needed basis) from these 3 clinical trials.

Table 1: Adverse Reactions Reported by Greater Than or Equal to 2% of Patients Treated with STENDRA From 3 Placebo-Controlled Clinical Trials Lasting 3 Months for STENDRA Use as Needed

Adverse Reaction Placebo
(N = 349)
STENDRA
50 mg
(N = 217)
STENDRA
100 mg
(N = 349)
STENDRA
200 mg
(N = 352)
Headache 1.7% 5.1% 6.9% 10.5%
Flushing 0.0% 3.2% 4.3% 4.0%
Nasal congestion 1.1% 1.8% 2.9% 2.0%
Nasopharyngitis 2.9% 0.9% 2.6% 3.4%
Back pain 1.1% 3.2% 2.0% 1.1%

Adverse reactions reported by greater than or equal to 1%, but less than 2% of patients in any STENDRA dose group, and greater than placebo included: upper respiratory infection (URI), bronchitis, influenza, sinusitis, sinus congestion, hypertension, dyspepsia, nausea, constipation, and rash.

In an, open-label, long-term extension study of two of these randomized, double-blind, placebo-controlled trials, the total duration of treatment was up to 52 weeks. Among the 712 patients who participated in this open-label extension study, the mean age of the population was 56.4 years (range from 23 to 88 years). The discontinuation rate due to adverse reactions for patients treated with STENDRA (50 mg, 100 mg, or 200 mg) was 2.8%.

In this extension trial, all eligible patients were initially assigned to STENDRA 100 mg. At any point during the trial, patients could request to have their dose of STENDRA increased to 200 mg or decreased to 50 mg based on their individual response to treatment. In total, 536 (approximately 75%) patients increased their dose to 200 mg and 5 (less than 1%) patients reduced their dose to 50 mg.

Table 2 presents the adverse reactions reported when STENDRA was taken as recommended (on an as-needed basis) in this open-label extension trial.

Table 2: Adverse Reactions Reported by Greater Than or Equal to 2% of Patients Treated With STENDRA in an Open-Label Extension Trial

Adverse Reaction STENDRA
(N = 711)
Headache 5.6%
Flushing 3.5%
Nasopharyngitis 3.4%
Nasal congestion 2.1%

Adverse reactions reported by greater than or equal to 1%, but less than 2% of patients in the open-label extension study included: upper respiratory infection (URI), influenza, sinusitis, bronchitis, dizziness, back pain, arthralgia, hypertension, and diarrhea.

The following events occurred in less than 1% of patients in the three placebo-controlled 3-month clinical trials and/or the open-label, long-term extension study lasting 12 months. A causal relationship to STENDRA is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use and reports too imprecise to be meaningful.

Body as a whole – edema peripheral, fatigue

Cardiovascular – angina, unstable angina, deep vein thrombosis, palpitations

Digestive – gastritis, gastroesophageal reflux disease, hypoglycemia, blood glucose increased, alanine aminotransferase increased, oropharyngeal pain, stomach discomfort, vomiting

Musculoskeletal – muscle spasms, musculoskeletal pain, myalgia, pain in extremity

Nervous – depression, insomnia, somnolence, vertigo

Respiratory – cough, dyspnea exertional, epistaxis, wheezing

Skin and Appendages – pruritus

Urogenital – balanitis, erection increased, hematuria, nephrolithiasis, pollakiuria, urinary tract infection

In an additional, randomized, double-blind, placebo-controlled study lasting up to 3 months in 298 men who had undergone bilateral nerve-sparing radical prostatectomy for prostate cancer, the mean age of patients was 58.4 years (range 40 - 70). Table 3 presents the adverse reactions reported in this additional study.

Table 3: Adverse Reactions Reported by Greater than or Equal to 2% of Patients Treated with STENDRA in a Placebo-Controlled Clinical Trial Lasting 3 Months in Patients Who Underwent Bilateral Nerve-Sparing Radical Prostatectomy

Adverse Reaction Placebo
(N = 100)
STENDRA
100 mg
(N = 99)
STENDRA
200 mg
(N = 99)
Headache 1.0% 8.1% 12.1%
Flushing 0.0% 5.1% 10.1%
Nasopharyngitis 0.0% 3.0% 5.1%
Upper respiratory infection 0.0% 2.0% 3.0%
Nasal congestion 1.0% 3.0% 1.0%
Back pain 1.0% 3.0% 2.0%
Electrocardiogram abnormal 0.0% 1.0% 3.0%
Dizziness 0.0% 1.0% 2.0%

A randomized, double-blind, placebo-controlled 2 months study was conducted in 435 subjects with a mean age of 58.2 years (range 24 to 86 years) to determine the time to onset of effect of STENDRA, defined as the time to the first occurrence of an erection sufficient for sexual intercourse. Table 4 presents the adverse reactions occurring in ≥ 2% of subjects treated with STENDRA.

Table 4: Adverse Reactions Reported by ≥ 2% of Patients Treated with STENDRA in a Placebo-Controlled Clinical Trial Lasting 2 Months to Determine the Time to Onset of Effect (Study 3)

Adverse Reaction Placebo
(N = 143)
STENDRA
100 mg
(N = 146)
STENDRA
200 mg
(N = 146)
Headache 0.7% 1.4% 8.9%
Nasal congestion 0.0% 0.7% 4.1%
Gastroenteritis viral 0.0% 0.0% 2.1%

Across all trials with any STENDRA dose, 1 subject reported a change in color vision.

Postmarketing Experience

Ophthalmologic

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Read the entire FDA prescribing information for Stendra (Avanafil)

Read More »

In Summary

Commonly reported side effects of avanafil include: headache and flushing. Other side effects include: nasopharyngitis. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to avanafil: oral tablet

General

The most common side effects reported were headache, flushing, nasal and sinus congestion and back pain.[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 10.1%)
Common (1% to 10%): Hypertension, abnormal electrocardiogram
Uncommon (0.1% to 1%): Peripheral edema, angina, unstable angina, deep vein thrombosis, palpitations, hot flush, increased heart rate
Rare (less than 0.1%): Tachycardia, chest pain, increased blood pressure, cardiac murmur
Postmarketing reports: Hypotension[Ref]

Genitourinary

Uncommon (0.1% to 1%): Balanitis, increased erection
Rare (less than 0.1%): Penis disorder, spontaneous penile erection, genital pruritus, increased prostate specific antigen
Postmarketing reports: Priapism, hematuria, hematospermia, penile hemorrhage[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dyspepsia, nausea, constipation
Uncommon (0.1% to 1%): Gastritis, gastroesophageal reflux disease, stomach discomfort, vomiting, dyspepsia, nausea
Rare (less than 0.1%): Dry mouth, lower abdominal pain[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia
Uncommon (0.1% to 1%): Muscle spasms, musculoskeletal pain, myalgia, pain in extremity, muscle tightness
Rare (less than 0.1%): Flank pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 12.1%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Somnolence, vertigo, sinus headache
Rare (less than 0.1%): Psychomotor hyperactivity[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, insomnia
Rare (less than 0.1%): Premature ejaculation, inappropriate affect[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria, nephrolithiasis, pollakiuria, urinary tract infection
Rare (less than 0.1%): Blood urine present[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, nasopharyngitis, upper respiratory infection (URI), bronchitis, sinusitis, sinus congestion
Uncommon (0.1% to 1%): Oropharyngeal pain, cough, exertional dyspnea, wheezing
Rare (less than 0.1%): Rhinorrhea, upper respiratory tract congestion[Ref]

Hematologic

Uncommon (0.1% to 1%): Epistaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased alanine aminotransferase
Rare (less than 0.1%): Increased blood bilirubin[Ref]

Immunologic

Common (1% to 10%): Influenza
Rare (less than 0.1%): Seasonal allergy[Ref]

Metabolic

Uncommon (0.1% to 1%): Hypoglycemia, increased blood glucose
Rare (less than 0.1%): Gout, Increased weight[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, vision loss
Postmarketing reports: Non-arteritic anterior ischemic optic neuropathy (NAION)[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, tinnitus
Rare (less than 0.1%): Asthenia, influenza-like illness, increased body temperature
Postmarketing reports: Loss of hearing[Ref]

Some side effects of avanafil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

-Mild to Moderate Renal Dysfunction (creatinine clearance greater than or equal to 30 and less than 90 mL/min): No adjustment recommended
-Severe Renal Dysfunction: Not recommended

Liver Dose Adjustments

-Mild to Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended
-Severe Liver Dysfunction: Not recommended

Avanafil Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity, embryotoxicity or fetotoxicity. There are no adequate and well controlled studies in pregnant women.

Not indicated for use in females. US FDA pregnancy category: C US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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