VYALEV (foscarbidopa)

Absorption VYALEV is administered directly into the subcutaneous space and is converted to carbidopa and levodopa by alkaline phosphatase. In a phase 1 study in healthy volunteers, carbidopa and levodopa were detectable in plasma within 30 minutes at the first pharmacokinetic (PK) collection point. In healthy volunteer subjects the steady state levodopa was achieved within 2 hours when VYALEV dosing was delivered as a loading dose followed by continuous infusion. Healthy volunteers were administ...

The efficacy of VYALEV was established in a 12-week, randomized, double-blind, double-dummy, active-controlled, multicenter study (Study 1; NCT04380142) in patients with advanced Parkinson’s disease (PD). Study 1 enrolled patients who were responsive to levodopa treatment, had motor fluctuations inadequately controlled by their current medications, and who experienced a minimum of 2.5 hours of “Off” time per day as assessed by PD diaries. A total of 141 patients were randomized in 1:1 ratio and received either 24-hour/day continuous subcutaneous administration of VYALEV plus oral placebo capsu...

The following serious adverse reactions are discussed below and elsewhere in labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 ) ] Hallucinations/Psychosis [see Warnings and Precautions ( 5.2 ) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.3 ) ] Infusion Site Reactions and Infections [see Warnings and Precautions ( 5.4 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.5 ) ] Dy...

VYALEV is contraindicated in patients who are currently taking a non-selective monoamine oxidase (MAO) inhibitor or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions ( 7.1 )] . VYALEV is contraindicated in patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor or have rec...

May cause falling asleep during activities of daily living. ( 5.1 ) Hallucinations/Psychosis: May respond to dose reduction of VYALEV. ( 5.2 ) Impulse Control Behaviors: Consider dose reductions or stopping VYALEV. ( 5.3 ) Infusion Site Reactions and Infections: Monitor for infusion site infections: Following aseptic techniques while using this medication and frequent rotation of the infusion site is recommended to reduce the risk. ( 5.4 ) Avoid sudden discontinuation or rapid dose reduction to ...

7 DRUG INTERACTIONS Selective MAO-B inhibitors: May cause orthostatic hypotension. ( 7.1 ) Antihypertensive drugs: May cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive drug may be needed. ( 7.2 ) Dopamine D2 receptor antagonists and isoniazid may reduce the effectiveness of VYALEV. ( 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use o...