Opsynvi®
This product is manufactured by Janssen Inc. and is a combination of two ingredients, macitentan and tadalafil.
This product is taken orally.
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orally
Why is it prescribed?
Opsynvi® is used in adults to treat certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels leading to the lungs.
Take Opsynvi® at approximately the same time every day. The tablets should be swallowed whole - do not break, crush or chew them. Store the tablets at room temperature in the original package.
Alternatives
See other products used in the treatment of •primary pulmonary hypertension •secondary pulmonary hypertension •
The recommended dosage is one tablet (macitentan 10 mg and tadalafil 40 mg) once daily.
Opsynvi® contains two medications that increase blood flow to the lungs. Macitentan blocks the effects of endothelin-1 which helps decrease blood pressure in the lungs. Tadalafil relaxes and widens the blood vessels in the lungs, allowing the blood to flow more easily.
Immediately seek medical help if you experience:
- chest pain
- an allergic reaction: difficulty swallowing or breathing, shortness of breath, wheezing, fever, skin rash, hives, swelling
- a painful erection of the penis lasting longer than 4 hours in duration
- sudden decrease or loss of hearing
- a sudden decrease or loss of vision
- memory loss
Other possible side effects
- fluid retention
- anemia - low iron
- headache
- flushing
- upset stomach, diarrhea
- flushing
- low blood pressure - dizziness, fainting
- headache
- back pain, pain in the arms or legs, muscle aches
- stuffed up or congested nasal passages
Do not use Opsynvi® if:
- taking nitrates in any form (oral, under the tongue, skin patch, or by inhalation). If you have chest pain while on OPSYNVI®, do NOT take nitroglycerin or nitrates. Get emergency help instead.
- you have Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION).
- taking guanylate cyclase stimulators eg riociguat
Use Opsynvi with caution in:
- pulmonary veno-occlusive disease (PVOD)
- heart disease or previously had a heart attack
- aortic stenosis (narrowing of the aortic heart valve)
- stroke
- low blood pressure or uncontrolled high blood pressure
- liver problems
- kidney problems or are on dialysis
- sickle cell anemia
- multiple myeloma, leukemia
- risk of developing an eye disorder such as retinitis pigmentosa
Avoid the following medications while on Opsynvi®:
- verapamil or diltiazem
- rifampicin, clarithromycin, ciprofloxacin, erythromycin
- ritonavir, saquinavir
- phenytoin, carbamazepine, phenobarbital
- ketoconazole, itraconazole, fluconazole, miconazole, voriconazole
- cyclosporine
- amiodarone
- bosentan
- doxazosin and other "alpha blockers"
- theophylline
- sildenafil, vardenafil
Do not drink grapefruit juice while on Opsynvi® as it can increase the effects of this medication.
Use in pregnancy: Opsynvi® can cause serious birth defects if taken during pregnancy. Females who can get pregnant must take a pregnancy test before starting this medication. Monthly pregnancy tests may be recommended to allow the early detection of pregnancy. R®eliable forms of contraception must be used while on Opsynvi and for at least 1 month after stopping treatment.
Use in breastfeeding: It is not known if this medication can pass into breast milk. Therefore, breastfeeding is not recommended.