Vybrique

Vybrique is used to treat erectile dysfunction (ED, impotence) in men. It is an oral film placed directly on the tongue approximately 1 hour before sexual activity when needed. The maximum dose is 25 mg to 100 mg once daily.

Vybrique is not for use in women or children.

Vybrique (sildenafil) gained FDA approval on December 16, 2025. There is no generic sildenafil oral film, but generic sildenafil tablets are available. Sildenafil has been approved since March 1998.

Take Vybrique exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Vybrique to take and when to take it. Your healthcare provider may change your dose if needed.

• Take Vybrique by mouth about 1 hour before sexual activity. You may take Vybrique between 30 minutes and 4 hours before sexual activity if needed.
• Vybrique can be taken with or without food.
• Do not cut or chew Vybrique.
• Do not take Vybrique more than 1 time a day.
• If you take too much Vybrique, call your healthcare provider or go to the nearest hospital emergency room right away.

Instructions for Use

• Do not remove the film from the pouch unless ready for immediate use.
• Do not handle the oral film with wet hands.

• Take the pouch and locate the notch on the side of the pouch.
• Gently tear along the dotted line to open the pouch
• Gently peel both parts of the pouch. Now you can hold each side of the pouch between your thumb and your index finger.
• Take the oral film with dry fingers out of the pouch and put it onto your tongue. It will dissolve in your mouth and can be swallowed with saliva.

Sudden Blood Pressure Drop With Interacting Medicines

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 any other 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 Vybrique if you take medicines called guanylate cyclase stimulators, which include Riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

When Emergency Care is Needed for Heart Problems

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.

Heart Symptoms During Sex

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.

Sexually Transmitted Diseases

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

Do not take Vybrique if you:

• Take medicines called nitrates.
• Take any medicines called guanylate cyclase stimulators.
• Are allergic to sildenafil or any of the ingredients in Vybrique. See the end of this guide for a complete list of ingredients in Vybrique.

It is not known if Vybrique is safe and effective in women or children under 18 years of age.

Before taking Vybrique, tell your healthcare provider about all of your medical conditions, including 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
• Had heart surgery within the last 6 months
• Pulmonary hypertension
• Had a stroke
• Low blood pressure, or high blood pressure that is not controlled
• A deformed penis shape
• Had an erection that lasted for more than 4 hours
• Problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia
• Retinitis pigmentosa, a rare genetic (runs in families) eye disease
• Ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)
• Bleeding problems
• Have had stomach ulcers
• Liver problems
• Kidney problems or are having kidney dialysis.

Vybrique is not for use in females.

Common Side Effects

The most common side effects of Vybrique are:

• headache
• flushing
• upset stomach
• stuffy or runny nose
• dizziness.

Other side effects include:

• abnormal vision, such as changes in color and blurred vision
• back pain
• muscle pain
• nausea
• rash.

Serious Side Effects

Vybrique may cause the following other serious side effects.

An Erection That Will Not Go Away (Priapism)

If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, 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). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking Vybrique 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 experience ringing in their ears (tinnitus) or dizziness after taking Vybrique. If you have these symptoms, stop taking Vybrique and contact a healthcare provider right away.

Notes:

Tell your healthcare provider if you have any side effects that bother you or do not go away.

These are not all of the possible side effects of Vybrique. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Adult Dose of Vybrique for Erectile Dysfunction (ED)

• Initial dose: 50 mg orally placed on the tongue approximately 1 hour before sexual activity
• May be taken anywhere from 30 minutes to 4 hours before sexual activity
• Subsequent Doses: Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg.
• Maximum dose: Once daily.

Place the oral film directly onto your tongue, where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids.

Vybrique (sildenafil) works by preventing the breakdown of cyclic GMP and enhancing nitric oxide (NO) -mediated smooth muscle relaxation. In erectile dysfunction (ED), this increases blood flow to the penile tissue, facilitating an erection.

Vybrique belongs to the drug class called phosphodiesterase type 5 (PDE5) inhibitors.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Vybrique may affect the way other medicines work, and other medicines may affect the way Vybrique works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• Nitrates, such as nitroglycerin sublingual tablets/spray/IV and isosorbide dinitrate/mononitrate. See Important Information above
• Guanylate cyclase stimulators, such as riociguat. See Important Information above
• Alpha blockers such as doxazosin. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Vybrique with alpha-blockers can lead to a drop-in blood pressure or to fainting
• HIV protease inhibitors, such as ritonavir and saquinavir
• Some types of oral antifungal medicines, such as ketoconazole and itraconazole
• Some types of antibiotics, such as erythromycin
• 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.

Store Vybrique at room temperature between 68°F and 77°F (20°C and 25°C).

Keep out of the reach of children.

Active ingredient: sildenafil

Inactive ingredients: Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, and titanium dioxide.

Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Vybrique oral film is available as 25 mg, 50 mg, 75 mg, and 100 mg of sildenafil

Vybrique is manufactured by Altergon Italia Srl, via Zona Industriale, Morra de Sanctis, Avellino 83040, Italy.

Manufactured for IBSA Institut Biochimique SA, CH-6912 Pazzallo, Switzerland.

Distributed by IBSA Pharma Inc, Parsippany, NJ 07054 USA.

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