Safinamide Disease Interactions

Dopamine agonists may impair the systemic regulation of blood pressure, with resultant orthostatic hypotension, especially during dose escalation. Therapy with dopamine agonists should be monitored carefully in patients with Parkinson's disease since they may have an impaired ability to respond to an orthostatic challenge, and also in patients receiving antihypertensive drugs.

Ordinarily, patients with major psychotic disorder should not be treated with dopaminergic antiparkinson agents, because of the risk of exacerbating psychosis. Hallucinations and psychotic-like behavior have been reported with dopaminergic medications. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of these drugs.

Safinamide is contraindicated in patients with severe hepatic dysfunction (Child-Pugh C). In patients with moderate hepatic impairment the maximum recommended dose is 50 mg orally once a day. If a patient taking this dose progresses from moderate to severe hepatic impairment, safinamide should be discontinued.

Safinamide may cause hypertension or exacerbate existing hypertension. Patients should be monitored for new onset hypertension or hypertension that is not adequately controlled after starting treatment. Dosage adjustment may be necessary if elevation of blood pressure is sustained.

Animal studies with safinamide showed retinal degeneration, loss of photoreceptor cells, cataracts, and retinal scarring. Patients should be periodically monitored for visual changes, especially if they have a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of retinal disease, albinism, retinitis pigmentosa, or active retinopathy (e.g., diabetic retinopathy).