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Overview: Opsynvi is an oral tablet used for pulmonary arterial hypertension. It helps relax blood vessels and lower blood pressure in the lungs, which may help prevent your symptoms from getting worse and improve your ability to exercise. Common side effects include fluid retention, headache, and low red blood cell levels. Opsynvi may cause harm to a fetus if taken during pregnancy. Other serious side effects may include low blood pressure, vision or hearing problems, liver damage, or a prolonged, painful erection.

Uses

What is Opsynvi used for?

Opsynvi (macitentan/tadalafil) is commonly used for pulmonary arterial hypertension (PAH). PAH is a condition where you have high blood pressure in the blood vessels (arteries) in your lungs. Over time, this pressure strains your heart and makes it harder for you to be physically active.

Opsynvi may also be used for other conditions as determined by your health care provider.

How does Opsynvi work (mechanism of action)?

Opsynvi contains two ingredients: macitentan and tadalafil. Both help relax blood vessels in the lungs.

  • Macitentan blocks endothelin-1, a substance that tightens blood vessels and worsens lung damage in people with pulmonary arterial hypertension. By blocking endothelin-1, macitentan helps relax the blood vessels and lower the blood pressure in the lungs. 
  • Tadalafil blocks the activity of an enzyme called phosphodiesterase 5 (PDE5). This enzyme normally stops some types of muscles from relaxing, including the muscles lining some types of blood vessels. By blocking PDE5, tadalafil helps relax blood vessels in the lungs.

Opsynvi can help improve your ability to be physically active, slow lung damage, and help prevent your symptoms from getting worse.

How is Opsynvi supplied (dosage forms)?

Brands and other names

  • Opsynvi

Dosage forms and strengths

  • 10 mg/20 mg, 10 mg/40 mg oral tablets

How should I store Opsynvi?

Opsynvi should be stored in its original container at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not throw away the desiccant that comes in the Opsynvi bottle. It helps protect the tablets from moisture.

Side Effects

What are the most common side effects of Opsynvi?

The most common side effects of Opsynvi are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Fluid retention (see below)
  • Low levels of red blood cells (anemia; see below)
  • Headache or migraine

There may be other side effects of Opsynvi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Opsynvi?

While less common, the most serious side effects of Opsynvi are described below, along with what to do if they happen.

Severe Allergic Reactions. Opsynvi may cause allergic reactions, which can be serious. Stop taking Opsynvi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Opsynvi. Keep all lab test appointments to monitor for signs of liver problems. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Fluid Retention (Edema). Opsynvi can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure. Call your health care provider right away if you have any of the following symptoms.

  • Chest pain
  • Shortness of breath that is worse than usual
  • Stretched or shiny skin
  • Unusual weight gain
  • Swelling of your ankles, legs, belly, or other body areas

Anemia. Opsynvi may cause anemia, which is when you have low levels of red blood cells and low hemoglobin. Hemoglobin is a protein in red blood cells that carries oxygen throughout your body. Keep all appointments to have your blood checked while taking Opsynvi. Tell your health care provider if you have any of the following symptoms of anemia.

  • Unusual weakness or tiredness
  • Cold hands and feet
  • Fast or abnormal heartbeat
  • Pale or yellowish skin 
  • Dizziness, lightheadedness, or feeling like you are about to pass out

Low Blood Pressure (Hypotension). Opsynvi may cause low blood pressure. If you feel faint or dizzy, lie down. Tell your health care provider right away if you have any of the following symptoms of low blood pressure.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Feeling weak or tired

Painful, Prolonged Erection (Priapism). Opsynvi may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly. Stop taking Opsynvi and get emergency help right away if you have any of the following symptoms of priapism.

  • Erection lasting for more than 4 hours
  • Erection that is unrelated to sexual stimulation
  • Painful, swollen, or tender penis

Vision Changes. Opsynvi can cause mild, temporary vision changes such as blurry vision or sensitivity to light. Though rare, serious eye problems, including permanent vision loss, have been reported. Stop taking Opsynvi and get help right away if you have any of the following.

  • Sudden reduced vision or loss of vision in one or both eyes
  • Blurry or cloudy vision
  • Sensitivity to light
  • Trouble seeing upon waking up
  • Seeing colors incorrectly

Hearing Loss. Opsynvi may cause a sudden decrease or loss of hearing. Stop taking Opsynvi and tell your health care provider right away if you have hearing loss or any of the following symptoms.

Warnings & Precautions

Who should not take Opsynvi?

Allergies to Ingredients. People who are allergic to any of the following should not take Opsynvi.

  • Macitentan
  • Opsynvi
  • Tadalafil
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Opsynvi.

Pregnancy. Do not take Opsynvi if you are pregnant or plan to become pregnant. If you become pregnant or think you might be pregnant, contact your health care provider right away. See the Pregnancy section for more details.

Drug Interactions. Opsynvi should not be taken while you are using certain other medicines. Before taking Opsynvi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Opsynvi before taking it?

Do not take Opsynvi unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Opsynvi with other people, even if they have the same condition as you. It may harm them.

Keep Opsynvi out of the reach of children.

Do not cut, crush, or chew Opsynvi.

Opsynvi may lower sperm count and could make it hard for you to get your partner pregnant. If you have concerns, talk to your health care provider.

Opsynvi contains tadalafil, which is a phosphodiesterase 5 (PDE5) inhibitor. PDE5 inhibitors are medicines that can also be used for erectile dysfunction. Examples include sildenafil (Revatio, Viagra, and others), tadalafil (Cialis and others), or vardenafil (Levitra, Staxyn). Do not take Opsynvi with any other PDE5 inhibitor.

What should I tell my health care provider before taking Opsynvi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Opsynvi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Low levels of red blood cells (anemia)
  • Liver problems
  • Heart problems, such as heart failure or heart attack
  • Pulmonary veno-occlusive disease, a condition where certain blood vessels in the lungs are blocked or narrowed
  • Low blood pressure
  • Eye problems, such as an inherited eye disease called retinitis pigmentosa or a problem with the nerve between your eyes and brain (optic nerve)
  • Hearing problems
  • Blood cell problems, such as sickle cell disease or a blood cancer
  • Kidney problems or are on dialysis
  • Peyronie's disease, or a penis with an abnormal curve or shape 

Pregnancy. Opsynvi may cause harm to a fetus. You must not be pregnant before starting Opsynvi. If you can become pregnant, you must have a pregnancy test before starting Opsynvi, every month while taking it, and one month after stopping it to make sure you are not pregnant. You must also use a highly effective birth control method (such as tubal ligation) or a combination of methods (such as the pill plus condoms) while taking Opsynvi and for one month after your last dose. Talk to your health care provider about your birth control options. If you become pregnant or think you might be pregnant, contact your health care provider right away. 

Breastfeeding. Do not take Opsynvi while you are breastfeeding. It is not known if Opsynvi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Opsynvi?

For more information about Opsynvi, visit the drugmaker’s website at www.opsynvi.com or call them at 800-526-7736.

Interactions

Does Opsynvi interact with foods or drinks?

Your health care provider may recommend limiting or avoiding grapefruit while taking Opsynvi. Eating grapefruit or drinking grapefruit juice may increase levels of the medicine in your body, which could raise the risk of side effects of Opsynvi.

Do not have more than four drinks with alcohol in a short period of time while taking Opsynvi. The risk of side effects, such as dizziness, low blood pressure, and headache, may be higher if you drink alcohol while taking Opsynvi. It is best to limit the amount of alcohol you drink. 

Does Opsynvi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Opsynvi.

  • A nitrate, such as nitroglycerin (Nitro-Dur, NitroMist, Nitrostat, and others), isosorbide dinitrate (Isordil), or isosorbide mononitrate, which is a medicine used to prevent or treat short-lasting chest pain caused by a type of heart disease, or a street drug, such as amyl nitrite (“poppers”)
  • A guanylate cyclase stimulator, such as riociguat (Adempas), which is a medicine used for pulmonary arterial hypertension (PAH), or vericiguat (Verquvo), which is a medicine used for a type of heart failure
  • A phosphodiesterase 5 (PDE5) inhibitor, such as avanafil (Stendra), sildenafil (Revatio, Viagra, and others), tadalafil (Cialis and others), or vardenafil (Levitra, Staxyn), which is a medicine used for erectile dysfunction or PAH
  • Any other medicine for erectile dysfunction or PAH
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Amiodarone (Pacerone and others), which is a medicine used for an irregular heart rhythm
  • A medicine for HIV or AIDS
  • An alpha-blocker, such as alfuzosin (Uroxatral), doxazosin (Cardura), dutasteride, prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin), which is a medicine that may be used for high blood pressure and/or trouble peeing due to an enlarged prostate
  • A medicine for high blood pressure or heart problems

Many other medicines may alter the blood levels of Opsynvi. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Opsynvi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Opsynvi?

If you or someone else has taken too much Opsynvi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Opsynvi?

If you miss a dose, take it as soon as you remember that same day. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.