Opsynvi

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.

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.

• 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.

• 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).

• 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.

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).

• 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).

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.

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).

• 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.

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.