Foscarbidopa/Foslevodopa

Q: Is Foscarbidopa/Foslevodopa available over the counter?

Foscarbidopa/Foslevodopa is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Prescription

Brand names: Vyalev

Dosage Form

Injection

Route

SUBCUTANEOUS

Manufacturer

AbbVie Inc.

About This Medication

11 DESCRIPTION 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, in vivo . 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 S )-2-hydrazinyl-3-[3-hydroxy-4-(phosphonooxy)phenyl]-2-methylpropanoic acid trihydrate. Its empirical formula is C 10 H 15 N 2 O 7 P (anhydrous basis), and its structural formula is: 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 S )-2-amino-3-[3-hydroxy-4-(phosphonooxy)phenyl] propanoic acid. Its empirical formula is C 9 H 12 NO 7 P, and its structural formula is: 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. 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 (2S)-2-hydrazinyl-3-[3-hydroxy-4-(phosphonooxy)phenyl]-2-methylpropanoic acid trihydrate. Its empirical formula is C10H15N2O7P (anhydrous basis), and its structural formula is: 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 (2S)-2-amino-3-[3-hydroxy-4-(phosphonooxy)phenyl] propanoic acid. Its empirical formula is C9H12NO7P, and its structural formula is:

Active Ingredients

Ingredient	Strength
Foscarbidopa	-
Foslevodopa	-

Indications & Usage

1 INDICATIONS AND USAGE VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ( 1 )

How It Works

12.1 Mechanism of Action VYALEV is a prodrug combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate). Foscarbidopa and foslevodopa are converted in vivo to carbidopa and levodopa. Carbidopa When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. Levodopa Levodopa is the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa treats symptoms of Parkinson's disease.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. ( 2.1 , 2.2 , 2.3 ) See the Full Prescribing Information for calculation of the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose. ( 2.2 ) The maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa). ( 2.2 ) 2.1 Important Information For subcutaneous administration only. Patients selected for treatment with VYALEV should be capable of understanding and using the delivery system [see Healthcare Professional Instructions for Use of VYAFUSER Pump , and Patient Instructions for Use of VYAFUSER Pump ] themselves or with assistance from a caregiver. Patients should be trained on the proper use of VYALEV and the delivery system prior to initiating. 2.2 Recommended Dosage VYALEV (foscarbidopa and foslevodopa) is administered as a subcutaneous infusion with the VYAFUSER pump [ see Dosage and Administration ( 2.3 ), Healthcare Professional Instructions for Use of VYAFUSER Pump , and Patient Instructions for Use of VYAFUSER Pump ] . VYALEV Base Continuous Dosage and Hourly Infusion Rate The continuous infusion rate is based on total levodopa dosage (TLD). The hourly base continuous infusion rate (mL/hr) = [(TLD x 1.3) / 240] / [number of hours the patient is typically awake (e.g., 16 hours)], as shown in the steps below. Step 1: Calculate the TLD for the levodopa-containing medications that VYALEV is replacing. All dosages should be converted to the equivalent dosage of immediate-release levodopa to obtain the TLD. Prescribers should adjust the total dose of levodopa-containing products for COMT inhibitor use. See the Prescribing Information for the respective drugs for conversions or adjustments. Do not include rescue or as needed levodopa or any other anti-Parkinsonian medication or therapy, including medications taken outside of awake time (e.g., night-time dosing) in this calculation. Step 2: Determine the total daily dosage (mg) of VYALEV foslevodopa component by multiplying the TLD by 1.3. The conversion factor takes into account the molecular weight and bioavailability of foslevodopa compared to levodopa. Step 3: Determine the total daily volume (mL) of VYALEV by dividing the total daily dosage (mg) of VYALEV by 240. Each 1 mL of VYALEV contains 240 mg of foslevodopa. Step 4: Determine the hourly base continuous infusion rate of VYALEV by dividing the total daily volume (mL) of VYALEV by the number of hours the patient is typically awake (e.g., 16 hours). VYALEV may be administered over the patient’s waking hours or may be administered for 24 hours. See Dosage and Administration ( 2.3 ) for adjustment of and alternate infusion rates for lower overnight dosages. Maximum Dosage The maximum recommended daily dosage of VYALEV is 3,525 mg of the foslevodopa component (equivalent to approximately 2,500 mg levodopa). Optional Loading Dose If VYALEV therapy is being initiated in an “Off” state or the patient has not been receiving their base continuous infusion for more than 3 hours, a loading dose can be administered immediately prior to starting or re-starting the base continuous hourly infusion. Loading doses can be administered either with VYALEV or patients can continue using oral immediate-release carbidopa/levodopa tablets. The loading dose should be calculated from the first morning dose of oral immediate release carbidopa/levodopa the patient took before starting treatment with VYALEV. If VYALEV is used for the loading dose, multiply the first morning dose of oral immediate release levodopa by 1.3 and divide by 240 to determine the loading dose of VYALEV. The pump is capable of delivering a loading dose ranging from 0.1 mL to a maximum of 3 mL, in increments of 0.1 mL. Extra Dose An extra dose volume can be programmed to 1 of 5 options (see Table 1). The “extra dose” feature is limited to no more than 1 extra dose per hour. If 2 or more extra doses are used by the patient during the 24-hour/day treatment period, a revision of the base continuous infusion rate should be considered (refer to the Healthcare Professional Instructions for Use of VYAFUSER Pump details). Table 1. Extra Dose Option for VYALEV VYALEV extra dose volume Approximate equivalent levodopa dose * 0.1 mL 17 mg 0.15 mL 25.5 mg 0.2 mL 34 mg 0.25 mL 42.5 mg 0.3 mL 51 mg * See Step 1 2.3 Preparation and Administration Instructions Patients should be trained on the proper use of VYALEV and the delivery system prior to initiating treatment with VYALEV and, as necessary, thereafter [see Dosage and Administration ( 2.2 ) and the Patient Instructions for Use of VYAFUSER Pump ] . Preparation Use aseptic technique. Use sterile, single-patient-use infusion components (syringe, infusion set, and vial adapter) qualified for use with the pump to infuse VYALEV. Do not dilute. Do not mix VYALEV with other products. The medication vials are for single dose only. The entire contents of a VYALEV vial should be transferred into a syringe for administration. Do not withdraw a partial portion of the vial contents. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths ( 3 ) ] . The infusion set (cannula) can remain in place for up to 3 days when VYALEV is infused continuously. Administration Site Selection Administer VYALEV subcutaneously, preferably in the abdomen, avoiding the area with a 2-inch radius from the navel. Rotate the infusion site and use a new infusion set at least every 3 days. Select new infusion sites at least 1 inch from sites used within the previous 12 days. Do not infuse VYALEV into areas where the site is tender, bruised, red, or hard to the touch. Infusion Flow Rates Adjustment: Infusion rates may be adjusted in increments of 0.01 mL/hr (which is equivalent to approximately 1.7 mg of levodopa/hour). Alternative Flow Rates: The healthcare professional has the option to enable and pre-program the pump with 2 alternative continuous infusion rates (Low/High) that the patient may select to account for changes in functional demand (e.g., lowering the dosage at night or increasing the dose for prolonged intense activity) (see the Healthcare Professional Instructions for Use of VYAFUSER Pump ) . Discarding VYALEV and Syringe Discard the vial after transfer of the product to the syringe. Discard the syringe and any unused VYALEV in the syringe after the product has been in the syringe for 24 hours. 2.4 Interruption of Therapy Prescribing a backup oral carbidopa and levodopa product is recommended in the event that delivery of VYALEV is interrupted, which may result in underdosing. Sudden discontinuation or rapid dose reduction of VYALEV, without administration of alternative dopaminergic therapy, should be generally avoided [see Warnings and Precautions ( 5.5 )]. Following interruptions of more than 1 hour, a new infusion set (tubing and cannula) should be used and rotated to a different infusion site. If the infusion has been interrupted for longer than 3 hours, the patient may also self-administer a loading dose, if enabled by their healthcare professional [see Dosage and Administration ( 2.2 )] .

Side Effects Overview

6 ADVERSE REACTIONS 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 ) ] Dyskinesia [see Warnings and Precautions ( 5.6 ) ] Cardiovascular Ischemic Events [see Warnings and Precautions ( 5.7 ) ] Glaucoma [see Warnings and Precautions ( 5.8 )] Most common adverse reactions for VYALEV (VYALEV incidence at least 10% and greater than oral carbidopa-levodopa incidence) were infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In Study 1, a 12-week, active-controlled clinical trial, a total of 141 patients with advanced PD were enrolled [see Clinical Studies ( 14 )]. Of these, 74 patients received VYALEV and 67 received oral immediate-release carbidopa-levodopa with placebo subcutaneous infusion. Adverse reactions led to discontinuation of VYALEV in 22% of patients, which included hallucinations, infusion site reactions, and infusion site infections [see Warnings and Precautions ( 5.2 , 5.5 )]. Table 2 presents the adverse reactions that occurred in ≥3% of patients who received VYALEV and with a difference of >2% between the VYALEV and the oral immediate release carbidopa-levodopa groups in Study 1. Table 2. Adverse Reactions in Study 1 that Occurred in ≥3% of Patients with Advanced PD who Received VYALEV and 2% Difference from Active Control Adverse Reaction VYALEV (n = 74 ) % Oral immediate-release carbidopa-levodopa (n = 67 ) % Infusion/catheter site reaction a 62 8 Infusion/catheter site infection b 28 3 Hallucination 12 2 Dyskinesia 11 6 On and off phenomenon 8 0 Balance disorder 5 0 Constipation 5 0 Peripheral swelling 5 0 Agitation 4 2 Insomnia 4 2 Psychotic disorder c 4 2 Dyspnea 4 0 Infusion/catheter site reaction includes multiple related terms. Infusion site/catheter site infections includes multiple related terms. Psychotic disorder includes psychotic disorder, delusion, and paranoia.

Warnings & Precautions

5 WARNINGS AND PRECAUTIONS 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 reduce the risk of withdrawal-emergent hyperpyrexia and confusion. ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction of VYALEV. ( 5.6 ) 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 ( 14 )], 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. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with VYALEV. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of PD and may decrease the effectiveness of VYALEV [see Drug Interactions ( 7.3 ) ] . 5.3 Impulse Control/Compulsive Behaviors Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including VYALEV, that increase central dopaminergic tone and that are generally used for the treatment of PD. In some cases, although not all, these urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with VYALEV. Consider reducing the dose or discontinuing VYALEV if a patient develops such urges. 5.4 Infusion Site Reactions and Infections VYALEV can cause infusion site reactions and infections. In Study 1, one or more infusion site reactions were reported in 62% of patients treated with VYALEV and 8% of patients who received placebo subcutaneous infusion. Various types of reactions at the infusion site have been reported including: erythema, pain, edema, nodule, bruising, hemorrhage, induration, pruritus, extravasation, inflammation, mass, warmth, hematoma, pallor, rash, and swelling. In Study 1, 8% of patients treated with VYALEV and no patient who received placebo withdrew from treatment because of an infusion site reaction. In Study 1, infusion site infections occurred in 28% of patients treated with VYALEV compared to 3% of patients who received placebo subcutaneous infusion. In Study 1, 5% of patients treated with VYALEV and 2% who received placebo withdrew from treatment because of an infusion site infection. The most frequent infusion site infection reported was cellulitis. If an infection is suspected at the infusion site, the cannula should be removed from the infusion site. If the cannula is removed for an infection, either a new canula should be placed at a new infusion site or, in the event of a prolonged interruption, the patient should be prescribed an oral carbidopa and levodopa product until they are able to resume VYALEV [see Dosage and Administration ( 2.3 , 2.4 )] . 5.5 Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking VYALEV. If VYALEV is discontinued, the dose should be tapered to reduce the risk of hyperpyrexia and confusion [see Dosage and Administration ( 2.4 ) ] . 5.6 Dyskinesia VYALEV may cause or exacerbate dyskinesias. In Study 1, dyskinesia occurred in 11% of patients treated with VYALEV compared to 6% of patients treated with oral immediate-release carbidopa-levodopa. The occurrence of dyskinesias may require a dosage reduction of VYALEV or other medications used to treat PD. 5.7 Cardiovascular Ischemic Events In clinical studies, myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa (the active metabolites of VYALEV). Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias. 5.8 Glaucoma Carbidopa-levodopa (the active metabolites of VYALEV) may cause increased intraocular pressure in patients with glaucoma. Monitor intraocular pressure in patients with glaucoma after starting VYALEV.

Contraindications

4 CONTRAINDICATIONS 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 recently (within 2 weeks) taken a nonselective MAO inhibitor. ( 4 )

Pharmacokinetics

12.3 Pharmacokinetics 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 administered VYALEV to different subcutaneous sites (i.e., abdomen, arm, and thigh) using a 3-way crossover design. PK analysis from this study showed that the 3 sites provided comparable carbidopa and levodopa exposure suggesting VYALEV absorption is similar at the different subcutaneous sites. Effect of Food VYALEV bypasses the gut, so consumption of food does not change absorption or systemic exposure of carbidopa/levodopa. Distribution Both foslevodopa and foscarbidopa have binding to plasma proteins between 24% to 26%. Levodopa Levodopa is distributed between erythrocytes and plasma in approximately 1:1 ratio. Levodopa binding to plasma proteins is< 10%. Levodopa is transported into the brain by the carrier mechanism for large neutral amino acids. Carbidopa Carbidopa is approximately 36% bound to plasma protein. Carbidopa does not cross the blood-brain barrier. Metabolism and Excretion The foscarbidopa and foslevodopa from VYALEV are converted by alkaline phosphatases into carbidopa and levodopa. Levodopa Levodopa is mainly eliminated via metabolism by the aromatic amino acid decarboxylase (AAAD) and the catechol-O-methyl-transferase (COMT) enzymes. Other routes of metabolism are transamination and oxidation. The decarboxylation of levodopa to dopamine by AAAD is the major enzymatic pathway when no enzyme inhibitor is co-administered. O-methylation of levodopa by COMT forms 3-O-methyldopa. When administered with carbidopa, the elimination half-life of levodopa is approximately 1.5 hours. Carbidopa Carbidopa is metabolized to two main metabolites (α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3,4-dihydroxyphenylpropionic acid). These 2 metabolites are primarily eliminated in the urine unchanged or as glucuronide conjugates. Unchanged carbidopa accounts for 30% of the total urinary excretion. The elimination half-life of carbidopa is approximately 2 hours.

Frequently Asked Questions

1 INDICATIONS AND USAGE VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ( 1 )

2 DOSAGE AND ADMINISTRATION For subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. ( 2.1 , 2.2 , 2.3 ) See the Full Prescribing Information for calculation of the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose. ( 2.2 ) The maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa). ( 2.2 ) 2.1 Important Information For subcutaneous administration only. Patients selected for treatment with VYALEV should …

5 WARNINGS AND PRECAUTIONS 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 …

4 CONTRAINDICATIONS 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 recently (within 2 weeks) taken a nonselective MAO inhibitor. ( 4 )

Foscarbidopa/Foslevodopa is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Foscarbidopa/Foslevodopa drug label (National Library of Medicine)
• openFDA — Foscarbidopa/Foslevodopa label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 2695782 (NLM Normalized Drug Names)
• NDC Directory — Foscarbidopa/Foslevodopa (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS