VYALEV requires careful patient monitoring due to potential serious adverse events including somnolence, psychiatric effects, impulse control issues, infusion site complications, and risks associated with abrupt discontinuation.
Critical Safety Considerations for VYALEV Therapy
VYALEV is contraindicated in patients concurrently using or having recently used nonselective MAO inhibitors due to hypertension risk. Key precautions include the potential for falling asleep during daily activities and somnolence, warranting caution with activities like driving. Hallucinations and psychosis may occur and might necessitate dose reduction. Patients should be monitored for impulse control behaviors (e.g., gambling, increased libido). Infusion site reactions and infections are common; aseptic techniques and site rotation are crucial. Sudden discontinuation or rapid dose reduction can lead to withdrawal-emergent hyperpyrexia and confusion. VYALEV may also cause or worsen dyskinesia. Cardiovascular ischemic events have been reported with carbidopa-levodopa, so patients with cardiac history require monitoring. Intraocular pressure should be monitored in glaucoma patients. Based on animal data, VYALEV may cause fetal harm.