Why VYBRIQUE | Proven Medicine for ED | VYBRIQUE™ (sildenafil) oral film

Results You Can Count On

A clinical study was conducted with 475 men with ED who took either VYBRIQUE™ or a placebo over 12 weeks.

The results of the study showed that VYBRIQUE improved the development and maintenance of an erection and achieving penetration vs placebo.

The study measured erectile function using 2 assessment tools: a questionnaire assessing several measures of sexual function, including the ability to achieve an erection, and a diary assessment used after each sexual intercourse, which measured the ability to achieve penetration and maintain an erection.

Door Hanger Zoom

Before You Take VYBRIQUE™

Tell your doctor about the medicines you take and your medical conditions. Do not take VYBRIQUE if you take medicines called nitrates or guanylate cyclase stimulators, or are allergic to sildenafil or ingredients in VYBRIQUE.
There are risks with taking VYBRIQUE, including possible serious side effects:
- An erection that will not go away (priapism)
- Sudden vision loss in one or both eyes
- Sudden hearing decrease or hearing loss
The risks of taking VYBRIQUE are outlined here.

Common Side Effects

Be aware of the side effects associated with VYBRIQUE, including the most common side effects:

Headache
Flushing
Upset stomach
Abnormal vision
Back pain

Nausea
Muscle pain
Dizziness
Rash
Stuffy or runny nose

VYBRIQUE will not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.

Please see additional Important Safety Information about VYBRIQUE.

Couple walking

Actor portrayals.

What is VYBRIQUE^™?

VYBRIQUE (sildenafil) oral film is a prescription medicine used to treat erectile dysfunction (ED). VYBRIQUE is not for use in women or children. It is not known if VYBRIQUE is safe and effective in women or children under 18 years of age.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION & USE

VYBRIQUE can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VYBRIQUE if you take medicines called nitrates. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

What is VYBRIQUE^™?

VYBRIQUE (sildenafil) oral film is a prescription medicine used to treat erectile dysfunction (ED). VYBRIQUE is not for use in women or children. It is not known if VYBRIQUE is safe and effective in women or children under 18 years of age.

IMPORTANT SAFETY INFORMATION

VYBRIQUE can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VYBRIQUE if you take medicines called nitrates. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take VYBRIQUE if you take medicines called guanylate cyclase stimulators, which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Do not take VYBRIQUE if you are allergic to sildenafil or any of the ingredients in VYBRIQUE.

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

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. VYBRIQUE does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency Virus (HIV).

VYBRIQUE can cause serious side effects including:

an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away because priapism can permanently damage your penis.
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 non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking VYBRIQUE and call your healthcare provider right away 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. If you have these symptoms, stop taking VYBRIQUE and contact a healthcare provider right away.

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

have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve 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 NAION
have bleeding problems
have or have had stomach ulcers
have liver problems
have kidney problems or are having kidney dialysis

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor especially if you take any of the following:

nitrates
guanylate cyclase stimulators, such as riociguat
alpha-blockers, such as doxazosin. The use with VYBRIQUE can lead to a drop in blood pressure or to fainting.
HIV protease inhibitors, such as ritonavir and saquinavir
oral antifungal medicines, such as ketoconazole and itraconazole
antibiotics, such as erythromycin
medicines that treat high blood pressure
other medicines or treatments for ED

The most common side effects of VYBRIQUE are: headache; flushing; upset stomach; stuffy or runny nose; and dizziness. Other side effects include: abnormal vision, such as changes in color vision and blurred vision; back pain; muscle pain; nausea; and rash.

These are not all of the possible side effects of VYBRIQUE. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088, or contact IBSA Pharma Inc. at 1‑800‑587‑3513.

Please click here for Full Prescribing Information and Patient Information.

ED=erectile dysfunction; HIV=human immunodeficiency virus.

INDICATION

VYBRIQUE^™ (sildenafil) oral film is indicated for the treatment of erectile dysfunction (ED).

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION &
INDICATION

CONTRAINDICATIONS

Nitrates: VYBRIQUE is contraindicated in patients using any form of organic nitrates or nitric oxide donors, either regularly and/or intermittently, as it potentiates the hypotensive effects of nitrates. The safe interval for administering nitrates after VYBRIQUE is unknown, even though sildenafil plasma levels are lower at 24 hours after dosing.

INDICATION

VYBRIQUE^™ (sildenafil) oral film is indicated for the treatment of erectile dysfunction (ED).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Nitrates: VYBRIQUE is contraindicated in patients using any form of organic nitrates or nitric oxide donors, either regularly and/or intermittently, as it potentiates the hypotensive effects of nitrates. The safe interval for administering nitrates after VYBRIQUE is unknown, even though sildenafil plasma levels are lower at 24 hours after dosing.

Hypersensitivity Reactions: VYBRIQUE is contraindicated in patients with a known hypersensitivity to sildenafil or any component of VYBRIQUE. Hypersensitivity reactions, including rash and urticaria, have been reported.

Concomitant Guanylate Cyclase (GC) Stimulators: Do not use VYBRIQUE in patients using a GC stimulator, such as riociguat; as PDE5 inhibitors, including VYBRIQUE, may potentiate the hypotensive effects of GC stimulators.

WARNINGS AND PRECAUTIONS

Cardiovascular risk: There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. VYBRIQUE should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

VYBRIQUE was not studied and is not recommended for use in patients with:

Myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
Resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);
Cardiac failure or coronary artery disease causing unstable angina.

Patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be sensitive to the actions of vasodilators, including VYBRIQUE.

Prior to prescribing VYBRIQUE, carefully consider cardiovascular status, especially in combination with sexual activity.

Prolonged erection: Prolonged erection (>4 hours) and priapism (painful erections >6 hours in duration) have been reported infrequently, but can result in permanent penile damage if untreated. Instruct patients to seek immediate medical assistance if an erection persists longer than 4 hours. Use VYBRIQUE with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, or leukemia).

Effects on the eye: Advise patients to stop VYBRIQUE and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Use VYBRIQUE with caution and only when the anticipated benefits outweigh the risks in patients with a history of NAION. Individuals with “crowded” optic disc are also considered at greater risk for NAION.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the sildenafil citrate clinical trials, and use in these patients is not recommended.

Sudden hearing loss: Advise patients to stop taking VYBRIQUE and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil.

Potential drug interactions: VYBRIQUE can potentiate the hypotensive effects of nitrates, GC stimulators, alpha-blockers, and antihypertensives. Initiate VYBRIQUE at 25 mg with concomitant use of alpha-blockers.

CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin) increase VYBRIQUE plasma exposure. Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Do not exceed 25 mg of VYBRIQUE in a 48-hour period with ritonavir. Consider a starting dose of 25 mg of VYBRIQUE with erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir).

Sexually transmitted diseases: Use of VYBRIQUE offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, counsel patients about protective measures.

Specific Populations: Consider a starting dose of 25 mg of VYBRIQUE for patients ≥65 years, patients with severe renal impairment, or patients with hepatic impairment.

Adverse Reactions: The most common adverse reactions (≥2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.

Please click here for Full Prescribing Information.

ED=erectile dysfunction.