VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).

Injection: 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL). Each single-dose vial contains 10 mL of a colorless to yellow to brown (may have a purple or red tint) and clear to slightly opalescent solution.

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

The following serious adverse reactions are discussed below and elsewhere in labeling:

In the event of an overdosage with VYALEV, the infusion should be stopped immediately. Administer intravenous fluids and maintain an adequate airway. Electrocardiographic monitoring should be used, and the patient observed carefully for the development of cardiac arrhythmias; if necessary, an appropriate antiarrhythmic therapy should be given. Patients must also be monitored for hypotension.

VYALEV injection is a solution that is a combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate).

Foscarbidopa and foslevodopa are prodrugs that undergo enzymatic bioconversion via intrinsic alkaline phosphatase to carbidopa and levodopa, respectively,

Foscarbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white to light yellow powder, freely soluble in aqueous media, with a molecular weight of 306.21 g/mol anhydrous. It is designated chemically as (2

Foslevodopa, an aromatic amino acid, is a white to off-white powder, freely soluble in aqueous media, with a molecular weight of 277.17 g/mol. It is designated chemically as (2

VYALEV (foscarbidopa and foslevodopa) injection is a sterile, preservative-free solution for subcutaneous infusion. VYALEV is supplied in a 10 mL single-dose glass vial that contains 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL).  VYALEV may contain sodium hydroxide and/or hydrochloric acid to adjust the pH to approximately 7.4.

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 capsules (N=74) or 24-hour/day continuous subcutaneous administration of placebo solution plus oral encapsulated carbidopa-levodopa immediate-release (IR) tablets (N=67). 

Patients had a mean age of 66.4 years and a mean disease duration of 8.6 years. Most (93%) of the patients were white, 2% were Asian, 3% Black and 70% of the patients were male. At baseline, approximately 74% of patients in the VYALEV group and 66% of patients in the oral IR carbidopa-levodopa group were taking at least 1 or more classes of PD medications other than carbidopa-levodopa.

The primary clinical outcome measure was the mean change from baseline to Week 12 in the total daily mean “On” time without troublesome dyskinesia (defined as "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia) based on PD diary.

The key secondary clinical outcome measure was the mean change from baseline to Week 12 in the total daily mean “Off” time. The “On” and “Off” time were normalized to a daily 16-hour awake period. Daily normalized "Off" and "On" times are averaged over valid PD diary days for each visit to obtain the average daily normalized times. VYALEV demonstrated statistically significant improvements from baseline to Week 12 in "On" time without troublesome dyskinesia compared with the oral IR carbidopa-levodopa group (p=0.0083; Table 3). VYALEV also demonstrated statistically significant improvements from baseline to Week 12 in “Off” time compared with the oral IR carbidopa-levodopa group (p=0.0054; Table 3).

Figure 1 shows results over time according to treatment for the efficacy variable (mean change from baseline to week 12 in the total daily mean normalized “On” time without troublesome dyskinesia based on PD diary).

* p ≤ 0.01. P value reflects comparison between treatment groups

CD = carbidopa; LD = levodopa; LS = least squares; SE = standard error

Note - Week 3 was an optional visit.

Figure 2 shows results over time according to treatment for the efficacy variable (mean change from baseline to week 12 in the total daily mean normalized “Off” time based on PD diary).

* p ≤ 0.01. P value reflects comparison between treatment groups

CD = carbidopa; LD = levodopa; LS = least squares; SE = standard error

Note - Week 3 was an optional visit.

Advise the patient to read the FDA-approved patient labeling (

Refer patients to the Instructions for Use for complete administration instructions. Inform patients of aseptic technique and of subcutaneous administration site selection and rotation

Inform patients that if they disconnect the pump for less than 1 hour (e.g., to shower or for a short medical procedure), a new infusion set (tubing and cannula) or rotation of the infusion site is not needed before resuming infusion, unless medically indicated. Instruct the patient to stop the pump and disconnect the tubing. The syringe can remain attached to the pump until the tubing is reconnected. Refer the patient to the

Inform patients that if they have a prolonged interruption of therapy lasting more than 1 hour, a new infusion set (tubing and cannula) should be used, and rotation to a different infusion site is required before resuming infusion. In addition, if VYALEV is interrupted for more than 3 hours, advise patients to administer a loading dose with either VYALEV or oral immediate-release carbidopa and levodopa

Alert patients to the potential sedating effects caused by VYALEV, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a common adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with VYALEV to gauge whether it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their healthcare professional. 

Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with VYALEV or when taking a concomitant medication that increases plasma levels of levodopa

Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations) and other symptoms of psychosis while taking VYALEV. Tell patients to report hallucinations, abnormal thinking, psychotic behavior, or confusion to their healthcare professional promptly should they develop

Advise patients that they may experience impulse control and/or compulsive behaviors while taking VYALEV. Advise patients to inform their healthcare professional if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with VYALEV 

Advise patients to contact their healthcare professional if they notice signs of inflammation or infection at the infusion site, such as local spreading of redness, swelling, warmth, pain, discoloration when they apply pressure to the area, and/or fever. Tell patients to follow aseptic techniques while using VYALEV and to regularly change the infusion site (at least every third day), using a new infusion set. Advise patients to make sure the new infusion site is at least 1 inch (2.5 cm) from a site used in the last 12 days. Instruct patients to remove the cannula if an infection at the infusion site occurs and to contact their healthcare provider. Inform patients that they may need to change the infusion site more often than every third day if they notice any of the above-mentioned signs of infection

Advise patients to contact their healthcare professional before stopping VYALEV. Tell patients to inform their healthcare professional if they develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness

Inform patients that VYALEV may cause or exacerbate pre-existing dyskinesias

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant during treatment

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed

Manufactured for:

NDC: 0074-0501-01

Injection

120 mg and 2,400 mg per 10 mL

(12 mg and 240 mg per mL)

abbvie