Opsynvi
Opsynvi is a combination medication containing two active ingredients: macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 or PDE5 inhibitor). Opsynvi is used to treat adults with pulmonary arterial hypertension (PAH), or high blood pressure in the lungs. The tablet is taken by mouth once per day with or without food. Common side effects include fluid buildup in the body, anemia, and headache.
What is Opsynvi (macitentan / tadalafil)?
What is Opsynvi (macitentan / tadalafil) used for?
Pulmonary arterial hypertension or PAH (high blood pressure in the lungs)
How Opsynvi (macitentan / tadalafil) works
Opsynvi is a combination of two medications that work together to lower the blood pressure in the lungs.
Macitentan is an endothelin receptor antagonist. It blocks the effects of a protein in your body called endothelin.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor. It blocks a protein in the body called PDE5.
By blocking endothelin and PDE5, Opsynvi (macitentan / tadalafil) relaxes the blood vessels that go from your heart to your lungs. This allows more blood to flow through, which lowers the amount of work your heart needs to do to pump blood to your lungs to get oxygen for your body.
Drug Facts
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What are the side effects of Opsynvi (macitentan / tadalafil)?
Common Side Effects
- Fluid buildup or swelling (21%)
- Anemia (19%)
- Headache (18%)
Other Side Effects
- Nausea
- Vomiting
- Stomach pain
- Muscle or back pain
- Pain in arm or leg
- Low blood pressure
- Common cold symptoms
- Flushing
- Nosebleed
- Vaginal bleeding
Serious Side Effects
- Liver problems: swelling of the stomach, yellowing of the skin or the whites of the eyes, dark or brown urine, confusion
- Low blood pressure: dizziness, lightheadedness, nausea, blurred vision, shallow and fast breathing, tiredness, fainting
- Anemia (low red blood cell count): tiredness, shortness of breath, irregular heartbeat, dizziness, chest pain, pale skin
- Fluid buildup in the body: shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; chest pain; unable to exercise; tiredness; unusual weight gain
- Hearing or vision loss
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Hearing loss, ringing in ears
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Prolonged or painful erection
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Sudden vision loss in one or both eyes
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Facial flushing, redness
- Headache
- Muscle pain
- Stomach pain
- Swelling of the ankles, hands, or feet
Pros and cons of Opsynvi (macitentan / tadalafil)
Pros
A first-choice treatment option for PAH
Convenient to take two medications in a single pill
Taken by mouth once per day
Cons
Can lower your blood pressure
Not safe to take while pregnant or breastfeeding
Only available as a tablet that must be swallowed whole
Pharmacist tips for Opsynvi (macitentan / tadalafil)
Mark your appointments on your calendar to see your prescriber or get any ordered blood work done while you're taking Opsynvi (macitentan / tadalafil). These appointments are important for making sure the medication is working well for you and is as safe for you as possible.
You can take Opsynvi (macitentan / tadalafil) with or without food. Taking it with food might help with possible stomach upset from the medication.
Swallow Opsynvi (macitentan / tadalafil) whole. Don't break, crush, or chew the tablet. Let your prescriber know if you can't swallow the tablets.
Opsynvi (macitentan / tadalafil) can cause your body to hold onto too much fluid and swell up. Contact your prescriber if you notice shortness of breath, unexpected weight gain, or swelling in the ankles or feet.
Avoid grapefruit or grapefruit juice while you're taking Opsynvi (macitentan / tadalafil). Grapefruit can raise the amount of the medication in your body, which can raise your risk for side effects.
Let your healthcare team know about all the medications (including vitamins and supplements) that you're taking or planning to take. Opsynvi (macitentan / tadalafil) interacts with many medications, like blood pressure medications, certain medications for enlarged prostate, and fluconazole (Diflucan), among others. Your care team can check for harmful interactions and adjust your medications if needed.
Don't take a nitrate medication, such as nitroglycerin (Nitrostat), within 48 hours of taking Opsynvi (macitentan / tadalafil). Otherwise, your blood pressure can drop to dangerously low levels.
Don't stop taking Opsynvi (macitentan / tadalafil) unless your prescriber tells you to, even if you start to feel better. Stopping Opsynvi (macitentan / tadalafil) can cause your symptoms to come back and can worsen your PAH.
Frequently asked questions about Opsynvi (macitentan / tadalafil)
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What are the risks and warnings for Opsynvi (macitentan / tadalafil)?
Opsynvi (macitentan / tadalafil) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not safe to use during pregnancy
Don't take Opsynvi (macitentan / tadalafil) if you're pregnant. This medication can cause severe and life-threatening harm to unborn babies. For this reason, Opsynvi (macitentan / tadalafil) is available only through the Macitentan-Containing Products REMS program if you're assigned female at birth. This Risk Evaluation and Mitigation Strategies (REMS) program helps make sure that the medication is as safe as possible for you.
If you're able to become pregnant, your prescriber will ask you to take a pregnancy test before you start Opsynvi (macitentan / tadalafil), monthly during treatment, and once more a month after you stop the medication. You should also use birth control during treatment with Opsynvi (macitentan / tadalafil) and for at least 1 month after you complete treatment. Let your care team know right away if you become pregnant during treatment.
Liver damage
Medications similar to Opsynvi (macitentan / tadalafil) can cause liver problems that can sometimes lead to liver failure. You'll need to get blood tests to check your liver health before you start treatment and while you're taking the medication. These blood tests make sure your liver is working properly. Get medical attention right away if you have symptoms of liver problems, such as stomach pain, yellowing of your skin or the whites of your eyes, nausea, vomiting, or dark urine. You might need to stop taking Opsynvi (macitentan / tadalafil) to prevent further liver damage.
Low blood pressure
Risk factors: Certain heart problems | Low fluids in the body | Drinking alcohol | Also taking erectile dysfunction medications | Also taking blood pressure-lowering medications | Also taking nitrates like nitroglycerin
Opsynvi (macitentan / tadalafil) can sometimes cause your blood pressure to drop, which can make you feel dizzy, tired, or lightheaded. Some medications can interact with Opsynvi (macitentan / tadalafil), making these effects worse. When you take Opsynvi (macitentan / tadalafil), make sure to sit down for the first few minutes to avoid dizziness or fainting. Change positions slowly until your body gets used to the medication. Get emergency help if you feel like you're going to pass out in addition to having fast breathing, an irregular heartbeat, blurry vision, or cold and clammy skin.
Anemia (low red blood cell count)
Risk factors: Severe anemia
Opsynvi (macitentan / tadalafil) might cause your hemoglobin levels to go down. Hemoglobin is the protein on your red blood cells that carries oxygen throughout your body. Low hemoglobin levels can lead to anemia. Speak with your prescriber before you start treatment if you have a history of anemia to make sure this medication is safe for you.
During treatment, you might need to get blood tests done if you have symptoms of anemia so your prescriber can check your hemoglobin levels. Let your prescriber know if you experience weakness, shortness of breath, dizziness, fast or irregular heartbeat, or pale skin while you're taking Opsynvi (macitentan / tadalafil).
Vision changes
Risk factors: Over age 50 | High blood sugar | High blood pressure | Heart disease | High cholesterol | Smoking | History of eye problems, including a "crowded" optic disc
Although rare, there have been reports of permanent eye damage that might be linked to taking PDE5 inhibitors such as tadalafil (one of the medications in Opsynvi). This particular type of eye damage is called non-arteritic anterior ischemic optic neuropathy (NAION), which is caused by poor blood flow to the nerves in the eye.
Tell your prescriber about your full medical history before you start Opsynvi (macitentan / tadalafil). You might be at higher risk for this eye problem if you have certain medical conditions or if an optometrist or ophthalmologist has told you that you have a "crowded" optic disc. It's recommended to see your eye specialist to get routine eye exams done while you're taking Opsynvi (macitentan / tadalafil). Go to the emergency room or call an eye specialist right away if you suddenly notice changes in your vision in one or both eyes.
Hearing loss
Some people who took tadalafil, an ingredient in Opsynvi, reported experiencing hearing loss. It can sometimes happen with ringing in the ears (tinnitus) and dizziness. It isn't clear whether these effects are related to the medication or to other factors. Let your prescriber know if you notice changes in your hearing in one or both ears while you're taking Opsynvi (macitentan / tadalafil).
Fluid buildup in the body
Risk factors: Heart failure
Opsynvi (macitentan / tadalafil) can cause fluid buildup in the body, leading to swelling or shortness of breath. Fluid buildup can start to happen within weeks of starting treatment. This fluid buildup can be severe if you have a history of heart failure, and it can worsen your heart condition. Let your prescriber know before you start treatment if you have any heart problems or heart failure. And contact your care team if you have any signs of heart failure, like shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; not being able to exercise; or tiredness while you're taking Opsynvi (macitentan / tadalafil).
Avoid use with other PDE5 inhibitors
Tadalafil, one of the active ingredients in Opsynvi, is also available under several other brand names, such as Adcirca, Alyq, Tadliq, and Cialis. Don't take Opsynvi (macitentan / tadalafil) with other PDE5 inhibitors, including other formulations of tadalafil, because they haven't been studied together. But taking more than one PDE5 inhibitor at the same time might raise the risk for side effects, including dizziness, headaches, and flushing.
Serious problems in people with PVOD
Opsynvi (macitentan / tadalafil) isn't recommended if you have pulmonary vascular occlusive disease (PVOD), a rare condition that affects the blood flow between your lungs and heart. Opsynvi (macitentan / tadalafil) hasn't been studied in people with PVOD, but it's possible that it can make this condition worse. Seek medical help if you notice signs of fluid in your lungs (e.g., shortness of breath, coughing that doesn't go away, tiredness, chest pain). You'll get examined for PVOD. And if you're diagnosed with this rare form of pulmonary hypertension, you'll need to stop taking Opsynvi (macitentan / tadalafil).
Prolonged or painful erection (priapism)
Risk factors: Sickle cell anemia | Multiple myeloma | Leukemia | Medical conditions that affect the penis
There are rare reports of people who've experienced an erection lasting more than 4 hours after they've taken PDE5 inhibitors like tadalafil, one of the ingredients in Opsynvi. Reports also include those of painful erections lasting longer than 6 hours (priapism). This can cause permanent damage to your penis if not treated in time. Get medical help right away if you have an erection that lasts longer than 4 hours or if you feel pain during an erection.
Lower sperm count
Talk to your prescriber about the risks and benefits of taking Opsynvi (macitentan / tadalafil) if you're assigned male at birth and you might want to have children in the future. Both macitentan and tadalafil might affect sperm, which might lead to problems with your ability to have children. It's not known whether this effect is reversible.
Opsynvi (macitentan / tadalafil) dosage forms
Typical dosing for Opsynvi (macitentan / tadalafil)
The typical dose is one 10 mg/20 mg (macitentan/tadalafil) tablet or one 10 mg/40 mg (macitentan/tadalafil) tablet by mouth once daily. Your dose will depend on what other PAH medications you're taking.
How much does Opsynvi (macitentan / tadalafil) cost?
Opsynvi (macitentan / tadalafil) contraindications
Currently pregnant
Allergy to macitentan or tadalafil
Taking nitrates, such as nitroglycerin or amyl nitrite)
Taking riociguat (Adempas) or other sGC stimulators
What are alternatives to Opsynvi (macitentan / tadalafil)?
Pulmonary arterial hypertension or PAH (high blood pressure in the lungs)
Pulmonary arterial hypertension (PAH)
Opsynvi (macitentan / tadalafil) images
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References
Best studies we foundActelion Pharmaceuticals US, Inc. (2024). Opsynvi- macitentan and tadalafil tablet, film coated [package insert]. DailyMed.
Al Othman, B., et al. (2024). Pseudopapilledema. American Academy of Ophthalmology.
Fagan, K. A., et al. (2001). Role of endothelin-1 in lung disease. Respiratory Research.
Grünig, E., et al. (2024). Randomized trial of macitentan/tadalafil single-tablet combination therapy for pulmonary arterial hypertension. Journal of the American College of Cardiology.
Humbert, M., et al. (2022). 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension: Developed by the task force for the diagnosis and treatment of pulmonary hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Endorsed by the International Society for Heart and Lung Transplantation (ISHLT) and the European Reference Network on rare respiratory diseases (ERN-LUNG). European Heart Journal.
MedlinePlus. (2015). Pulmonary veno-occlusive disease.
MedlinePlus. (2022). Hemoglobin test.
North American Neuro-Ophthalmology Society. (n.d.). Non-arteritic anterior ischemic optic neuropathy.
U.S. Food and Drug Administration. (2023). Risk evaluation and mitigation strategies | REMS.
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