What Is Opsynvi Used For?

Opsynvi is a combination tablet containing two medicines – macitentan and tadalafil – specifically designed to treat pulmonary arterial hypertension (PAH) in adults.

Primary Uses

Opsynvi is used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels that carry blood from the heart to the lungs. In people with PAH, these arteries become narrower, forcing the heart to work harder to pump blood through them, causing tiredness, dizziness, and shortness of breath.

How It Works

Opsynvi works by widening the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure in the vessels carrying blood from the heart to the lungs and may improve your symptoms. You should only switch to Opsynvi after being on stable doses of macitentan and tadalafil as separate tablets.

How to Take Opsynvi

Take Opsynvi exactly as prescribed by your doctor. The medication should be taken consistently at the same time each day.

Dosage Instructions

The recommended dose is one tablet once daily. You can take Opsynvi with or without food. Swallow the whole tablet with a glass of water – do not chew or break the tablet. Take it at the same time each day and continue until your doctor tells you to stop.

What If You Miss a Dose?

If you miss your dose at the usual time, take it as soon as you remember, then continue taking your tablets at the usual times. Do not take a double dose to make up for the missed dose.

Available Tablet Strengths

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

• Low number of red blood cells (anemia)
• Swelling from fluid buildup
• Nose or throat infection
• Headache or migraine
• Flushing
• Sweating
• Nausea
• Indigestion
• Back pain
• Arm or leg pain
• Muscle pain
• Dizziness
• Stomach discomfort
• Diarrhea
• Blurred vision
• Nasal congestion
• Cough

Important Warnings

Opsynvi has several important warnings and contraindications that you must discuss with your doctor before starting treatment.

Who Should Not Take Opsynvi

Do not take Opsynvi if you: are allergic to macitentan, tadalafil, or any ingredients; are pregnant, planning pregnancy, or could become pregnant without reliable birth control; have serious liver problems or very high liver enzyme levels; take nitrates like amyl nitrite for angina; have had vision loss (NAION); had a heart attack in the last 3 months; have severe low blood pressure; have heart problems like angina, arrhythmias, uncontrolled high blood pressure, or stroke in the last 6 months; take guanylate cyclase stimulators like riociguat.

Medical Conditions to Discuss

Tell your doctor if you have: pulmonary veno-occlusive disease; heart problems other than pulmonary hypertension; blood pressure or blood vessel problems; hereditary eye disease; sickle cell anemia; multiple myeloma or leukemia; penis deformity or persistent erections lasting more than 4 hours; liver or kidney problems; lactose intolerance. You will need regular blood tests to monitor for anemia and liver function.

Pregnancy and Breastfeeding

Opsynvi may cause birth defects and must not be taken if pregnant or planning pregnancy. Women of childbearing potential must use at least two reliable forms of birth control during treatment and for at least 3 months after stopping. Monthly pregnancy tests are required. Do not breastfeed while taking Opsynvi. Men should use appropriate contraception to avoid exposing partners to semen, as Opsynvi may lower sperm count.

Drug Interactions

Several medications can interact with Opsynvi and affect how it works. Always tell your doctor about all medicines you’re taking.

• Antibiotics (rifampicin, clarithromycin, ciprofloxacin, erythromycin)
• Seizure medications (phenytoin, carbamazepine)
• St. John’s Wort
• HIV medications (ritonavir)
• Antifungal medications (ketoconazole, fluconazole, itraconazole, miconazole, voriconazole)
• Heart rhythm medications (amiodarone)
• Immunosuppressants (ciclosporin)
• Nitrates (glyceryl trinitrate)
• Guanylate cyclase stimulators (riociguat)
• Other PAH treatments (bosentan, sildenafil)
• Alpha blockers for blood pressure or prostate problems
• Calcium channel blockers (diltiazem, verapamil)
• Blood pressure medications
• Erectile dysfunction tablets (PDE5 inhibitors)

Alcohol & Driving

Opsynvi can affect your ability to drive safely and may interact with alcohol.

Alcohol

When taking Opsynvi with large amounts of alcohol, you may experience dizziness. Tell your doctor if you drink alcohol.

Driving and Operating Machinery

Opsynvi can cause dizziness and affect your vision. Be careful driving or operating machinery until you know how Opsynvi affects you.

Storage

Store Opsynvi below 30°C in the original package. Keep in a cool, dry place away from moisture, heat, or sunlight. Do not store in the bathroom, near a sink, in the car, or on window sills. Keep out of reach of children. Take expired or unwanted medicine to any pharmacy for safe disposal.

Overdose Information

If you think you have taken too much Opsynvi, seek urgent medical attention immediately. Contact the Poisons Information Centre (13 11 26), your doctor, or go to the nearest hospital Emergency Department, even if you feel fine.

Frequently Asked Questions