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Opsynvi (macitentan and tadalafil) is an oral tablet used to treat pulmonary arterial hypertension (PAH).

Opsynvi is available as film-coated tablets containing: macitentan 10 mg and tadalafil 20 mg macitentan 10 mg and tadalafil 40 mg

Opsynvi is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH).

By blocking endothelin and PDE5, Opsynvi 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.

Opsynvi is given as 1 tablet once daily with or without food.

Opsynvi is a safe and effective treatment when used for FDA approved indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not take this medication if you are allergic to any ingredients in Opsynvi, are pregnant, or are taking organic nitrates or guanylate cyclase (GC) stimulators.

Common side effects of Opsynvi: Fluid build up or swelling Anemia Headache Nausea Vomiting Stomach pain Muscle or back pain Pain in arm or leg Low blood pressure Common cold symptoms Flushing

Serious side effects are rare with Opsynvi. Contact your healthcare provider immediately if you experience any of the following: 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, light headedness, 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 build up 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

The following medications may interact with Opsynvi: Strong CYP3A4 inducers/inhibitors: Avoid concomitant use. Moderate dual or combined CYP3A4 and CYP2C9 inhibitors: Avoid concomitant use.

Actelion Pharmaceuticals US, Inc.

Opsynvi can cause serious birth defects if taken during pregnancy. Females must not be pregnant when they start taking Opsynvi or become pregnant during treatment or for 1 month after stopping treatment with Opsynvi.

• Macitentan/Tadalafil