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Opsynvi Disease Interactions

There are 13 disease interactions with Opsynvi (macitentan / tadalafil).

Major

Endothelin receptor antagonists (applies to Opsynvi) hepatotoxicity/liver impairment

Major Potential Hazard, Moderate plausibility. Applicable conditions: Liver Disease

Endothelin receptor antagonists (ERAs) have been associated with aminotransferase elevations, hepatotoxicity, and cases of liver failure. Hepatic function should be assessed before treatment initiation and closely monitored during treatment. Therapy should be discontinued if aminotransferase elevations are accompanied by increases in bilirubin, or clinical symptoms of hepatotoxicity such as nausea, vomiting, fever, abdominal pain or jaundice. Treatment should be avoided in patients with elevated aminotransferases at baseline as monitoring for hepatotoxicity may be more difficult. In general, the use of ERAs is not recommended for patients with moderate to severe hepatic impairment.

Major

PDE5 inhibitors (applies to Opsynvi) cardiovascular disease

Major Potential Hazard, Moderate plausibility. Applicable conditions: Hypotension, Cerebral Vascular Disorder, History - Cerebrovascular Disease, History - Myocardial Infarction

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

Major

PDE5 inhibitors (applies to Opsynvi) renal dysfunction

Major Potential Hazard, High plausibility.

The plasma clearance of phosphodiesterase-5 (PDE5) inhibitors may be decreased in patients with severe renal impairment, resulting in drug accumulation. Therapy with these agents should be avoided in patients with severe renal disease or on renal dialysis. Dose adjustments might be needed based on individual renal assessment and tolerability if used in these patients.

Major

Tadalafil (applies to Opsynvi) pulmonary disease

Major Potential Hazard, Moderate plausibility. Applicable conditions: Pulmonary Heart or Vascular Disease, Pulmonary Edema

Tadalafil tablet for the treatment of pulmonary arterial hypertension (PAH) should not be used in patients with pulmonary veno-occlusive disease (PVOD) as it may significantly worsen the cardiovascular status of these patients. If signs of pulmonary edema develop during therapy, the possibility of associated PVOD should be considered.

Moderate

Endothelin receptor antagonists (applies to Opsynvi) anemia

Moderate Potential Hazard, Moderate plausibility.

Clinical studies have shown that most endothelin receptor antagonists decrease hemoglobin concentration and hematocrit levels. There are some postmarketing reports of anemia cases which needed blood transfusion. Hemoglobin and hematocrit levels should be measured prior to treatment initiation and should be monitored periodically thereafter. Initiation of therapy is not recommended in patients with clinically significant anemia.

Moderate

Endothelin receptor antagonists (applies to Opsynvi) fluid retention

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Congestive Heart Failure

Peripheral edema and fluid retention are known clinical consequences of pulmonary hypertension and also known effects of endothelin receptor antagonists. Caution and monitoring is recommended if these agents are used in patients with underlying left ventricular dysfunction or underlying heart failure, as they have an increased risk for developing significant fluid retention that may need treatment or require discontinuation.

Moderate

PDE 5 inhibitors (applies to Opsynvi) priapism

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Myeloproliferative Disorder, Sickle Cell Anemia, Peyronie's Disease, Cavernosal/Penile Tissue Abnormalities

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

Moderate

PDE5 inhibitors (applies to Opsynvi) alcoholism

Moderate Potential Hazard, Moderate plausibility.

Alcohol consumption may intensify the pressure-lowering effects of mild vasodilators, such as phosphodiesterase 5 (PDE5) inhibitors. Therefore, patients that consume alcohol should be warned to limit alcohol intake while receiving these agents.

Moderate

PDE5 inhibitors (applies to Opsynvi) hearing loss

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Tinnitus

Use of phosphodiesterase-5 (PDE5) inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients with hearing problems should stop taking these agents and seek prompt medical care.

Moderate

PDE5 inhibitors (applies to Opsynvi) liver disease

Moderate Potential Hazard, High plausibility.

Phosphodiesterase 5 (PDE-5) inhibitors are cleared predominantly by hepatic metabolism. The pharmacokinetic disposition of these agents has not been assessed in patients with severe hepatic impairment. No dosage modification is recommended for patients with mild to moderate hepatic impairment, however, therapy with these agents should not be administered to patients with severe hepatic impairment. In patients with mild hepatic impairment a lower dose of these agents should be used as initial therapy.

Moderate

PDE5 inhibitors (applies to Opsynvi) retinitis pigmentosa

Moderate Potential Hazard, Moderate plausibility.

Phosphodiesterase-5 (PDE5) inhibitors have been associated with transient impairment of color discrimination (blue/green) and blue- or color-tinged vision. These agents also inhibit phosphodiesterase-6 (PDE6), to a much lesser extent, which is involved in phototransduction in the retina. There are no controlled clinical data on the safety in patients with retinitis pigmentosa, a minority of whom may have genetic disorders of retinal phosphodiesterases. Therapy with these agents should be avoided in such patients.

Moderate

PDE5 inhibitors (applies to Opsynvi) seizure disorders

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Seizures

The use of phosphodiesterase 5 (PDE-5) inhibitors has been associated with seizures. Therapy with these agents should be administered cautiously in patients with preexisting seizure disorders.

Moderate

Tadalafil-visual disorders

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Retinitis Pigmentosa, Visual Defect/Disturbance, Optic Nerve Disorder

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

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Opsynvi drug interactions

There are 380 drug interactions with Opsynvi (macitentan / tadalafil).

Opsynvi alcohol/food interactions

There is 1 alcohol/food interaction with Opsynvi (macitentan / tadalafil).


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.