Foscarbidopa/foslevodopa - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS May cause falling asleep during activities of daily living.

Hallucinations/Psychosis: May respond to dose reduction of VYALEV.

Impulse Control Behaviors: Consider dose reductions or stopping VYALEV.

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.

Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion.

May cause or exacerbate dyskinesia: Consider dose reduction of VYALEV.

5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with levodopa (the active metabolite of VYALEV) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents.

Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event (sleep attack).

Some of these events have been reported more than one year after initiation of treatment.

Falling asleep while engaged in activities of daily living usually occurs in patients experiencing preexisting somnolence, although patients may not give such a history.

For this reason, prescribers should reassess patients for drowsiness or sleepiness while using VYALEV, especially since some of the events occur well after the start of treatment.

Prescribers should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Patients who have already experienced somnolence or an episode of sudden sleep onset should not participate in these activities while taking VYALEV.

Before initiating treatment with VYALEV, advise patients about the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with VYALEV such as the use of concomitant sedating medications or the presence of sleep disorders.

Consider discontinuing VYALEV in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating).

If VYALEV is continued, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patient becomes somnolent.

There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

5.2 Hallucinations/Psychosis There is an increased risk for hallucinations and psychosis in patients taking VYALEV.

In Study 1 [see Clinical Studies ], hallucinations occurred in 12.2% of patients treated with VYALEV compared to 1.5% of patients treated with oral immediate-release carbidopa-levodopa.

Psychosis occurred in 4.1% of patients treated with VYALEV compared to 1.5% of patients treated with oral immediate-release carbidopa-levodopa.

Treatment with VYALEV was discontinued in 1 (1.4%) patient because of hallucinations.

Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of VYALEV or other concomitantly administered medications.

Confusion, insomnia, and excessive dreaming may accompany hallucinations.

Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychosis, disorientation, aggressive behavior, agitation, and delirium.

Review of treatment is recommended if these symptoms develop.