Vyalev foscarbidopa/foslevodopa 12 mg/mL; 240 mg/mL Injection — NDC 0074-0501-01 (Billing 00074-0501-01)
This is a package of Vyalev foscarbidopa/foslevodopa 12 mg/mL; 240 mg/mL Injection from AbbVie Inc., marketed since Apr 2022 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0074-0501-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0074 labeler · 0501 product · 01 package
- Package marketed since
- Apr 12, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0074050101 1
- Medicaid fills, this package
- 163 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 085336
- GCN: 54793
- GPI-14 (Medi-Span): 73209902132020
- HICL (First Databank): 049183
- AHFS class code: 28:36.16.00
- RxCUI (RxNorm): 2695782
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Aromatic Amino Acid Decarboxylation Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Foscarbidopa and foslevodopa is used to treat Parkinson's Disease (brain disorder that causes unintended or uncontrollable movements). Foslevodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain. Foscarbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain.
Read the full MedlinePlus article ↗- It treats Parkinson’s disease and related parkinsonism, including parkinsonism after brain inflammation or carbon monoxide or manganese poisoning. Duopa is specifically for motor f...
- Follow your prescription exactly, since your doctor adjusts the dose slowly. Extended-release forms shouldn’t be chewed or crushed. Rytary and Crexont can be taken with or without...
- Nausea, dizziness, headache, vivid dreams, and uncontrolled movements called dyskinesia are common. Tell your doctor if these bother you, because a dose change may help.
- Be careful. Some people fall asleep suddenly with no warning, even after being on it a long time. If that happens, don’t drive or do risky activities, and tell your doctor.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $29.53 | $206.71 / 7 vials |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7356 | $0.702 / J7356 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00074-0501-01 You're viewing this Main listing | 7 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-04-12 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vyalev 12 mg/mL; 240 mg/mLthis 00074-0501-01 | AbbVie | 7 vials | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12251365 ↗ | Method of use | U-4030 | Jun 10, 2040 |
| US 9446059 ↗ | Drug substance | U-4030 | Oct 21, 2035 |
| US 10174061 ↗ | Method of use | U-4030 | Oct 21, 2035 |
| US 10730895 ↗ | Drug substance | — | Oct 21, 2035 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Oct 16, 2027 |
Is there a generic version of VYALEV 120 MG-2,400 MG/10ML VL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Levodopa and Carbidopa inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) For subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. ( 2.2 , 2.3 , 2.4 ) See the Full Prescribing Information for calculation of the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose.
( 2.3 ) The maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa). ( 2.3 )
2.1Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including VYALEV, periodically during treatment, and as clinically indicated [see Warnings and Precautions 5.7 ] . If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with VYALEV while supplementing vitamin B6.
2. 2 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. 3 Recommended Dosage VYALEV (foscarbidopa and foslevodopa) is administered as a subcutaneous infusion with the VYAFUSER pump [ see Dosage and Administration ( 2.4 ), 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 ( 2.4 ) 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 t… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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. Injection: 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL). ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
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 )
5.1Falling 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.
5.2Hallucinations/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 antagoniz… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 ) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions ( 5.7 ) ] Cardiovascular Ischemic Events [see Warnings and Precautions ( 5.8 ) ] Glaucoma [see Warnings and Precautions ( 5.9 )] 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.
6.1Clinical 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.
🔄 Drug Interactions ▾
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 )
7.1Monoamine Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use of nonselective MAO inhibitors (e.g., phenelzine and tranylcypromine) with VYALEV is contraindicated [see Contraindications ( 4 ) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating VYALEV. Selective MAO Inhibitors The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with VYALEV may be associated with orthostatic hypotension.
Monitor patients who are taking these drugs.
7.2Antihypertensive Drugs The concurrent use of VYALEV with antihypertensive medications can cause symptomatic postural hypotension. A dose reduction of the antihypertensive medication may be needed after starting or increasing the dosage of VYALEV.
7.3Dopamine D2 Receptor Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine) and isoniazid may reduce the effectiveness of foslevodopa. Monitor patients for worsening Parkinson’s symptoms when patients are taking these medications with VYALEV.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary There are no data on the developmental risk associated with the use of VYALEV (foscarbidopa and foslevodopa) in pregnant women. Foscarbidopa is a prodrug of carbidopa, and foslevodopa is a prodrug of levodopa. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data).
The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa-levodopa caused both visceral and skeletal malformations in fetuses at all doses and ratios of carbidopa-levodopa tested.
No teratogenic effects were observed when carbidopa-levodopa was administered to pregnant mice throughout organogenesis. There was a decrease in the number of live pups delivered by rats receiving carbidopa-levodopa during organogenesis.
8.2Lactation Risk Summary Foscarbidopa and Foslevodopa There are no adequate data on the presence of foscarbidopa or foslevodopa in human milk, the effects of foscarbidopa or foslevodopa on milk production or on the breastfed infant. Foscarbidopa is a prodrug of carbidopa, and foslevodopa is a prodrug of levodopa. Carbidopa There are no adequate data on the presence of carbidopa in human milk, the effects on the breastfed infant, or the effects on milk production.
Carbidopa is excreted in rat milk. Levodopa Levodopa has been detected in human milk after administration of carbidopa-levodopa. Levodopa decreases secretion of prolactin in humans, which may inhibit lactation.
There are no adequate data on the effects of levodopa on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYALEV and any potential adverse effects on the breastfed infant from VYALEV or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of VYALEV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data on the developmental risk associated with the use of VYALEV (foscarbidopa and foslevodopa) in pregnant women. Foscarbidopa is a prodrug of carbidopa, and foslevodopa is a prodrug of levodopa. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data).
The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa-levodopa caused both visceral and skeletal malformations in fetuses at all doses and ratios of carbidopa-levodopa tested.
No teratogenic effects were observed when carbidopa-levodopa was administered to pregnant mice throughout organogenesis. There was a decrease in the number of live pups delivered by rats receiving carbidopa-levodopa during organogenesis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of VYALEV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Because the decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available to the brain. The addition of carbidopa to levodopa reduces the peripheral effects (e.g., nausea and vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied VYALEV injection contains 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) and is a colorless to yellow to brown (may have a purple or red tint), and clear to slightly opalescent solution. Each single-dose glass vial is filled with approximately 10 mL of solution and is fitted with a grey rubber stopper, aluminum crimp cap, and turquoise plastic flip-off cap. The rubber stopper on the vial does not contain natural rubber latex.
Carton of 7 VYALEV vials: NDC 0074-0501-01 The VYAFUSER pump used to administer VYALEV (foscarbidopa and foslevodopa) is provided separately.
16.2Storage and Handling Keep the medication vials in the outer carton to protect the vials from breaking. Store VYALEV refrigerated at 2°C to 8°C (36°F to 46°F). VYALEV may be stored at room temperature up to a maximum of 30°C (86°F) for a single period of up to 28 days.
Once VYALEV has been stored at room temperature, do not return the product to the refrigerator. If stored at room temperature, discard VYALEV if not used within 28 days. Do not freeze.
Do not shake.
16.1How Supplied VYALEV injection contains 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) and is a colorless to yellow to brown (may have a purple or red tint), and clear to slightly opalescent solution. Each single-dose glass vial is filled with approximately 10 mL of solution and is fitted with a grey rubber stopper, aluminum crimp cap, and turquoise plastic flip-off cap. The rubber stopper on the vial does not contain natural rubber latex.
Carton of 7 VYALEV vials: NDC 0074-0501-01 The VYAFUSER pump used to administer VYALEV (foscarbidopa and foslevodopa) is provided separately.
📦 Storage and Handling ▾
16.2Storage and Handling Keep the medication vials in the outer carton to protect the vials from breaking. Store VYALEV refrigerated at 2°C to 8°C (36°F to 46°F). VYALEV may be stored at room temperature up to a maximum of 30°C (86°F) for a single period of up to 28 days.
Once VYALEV has been stored at room temperature, do not return the product to the refrigerator. If stored at room temperature, discard VYALEV if not used within 28 days. Do not freeze.
Do not shake.
📋 Description ▾
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:
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Administration Information Refer patients to the Instructions for Use for complete administration instructions. Inform patients of aseptic technique and of subcutaneous administration site selection and rotation [see Dosage and Administration ( 2.4 )] .
Instruct the patient to record the date when VYALEV is first removed from the refrigerator in the space provided on the carton [see Storage and Handling ( 16.2 )] . Interruption of VYALEV Infusion 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 Patient Instructions for Use for additional information. 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 [see Dosage and Administration ( 2.3 )] . Instruct patients to have oral carbidopa and levodopa available in case treatment with VYALEV is interrupted for 1 hour or longer. Falling Asleep during Activities of Daily Living and Somnolence 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 [see Warnings and Precautions ( 5.1 ) ] . Hallucinations/Psychosis/Confusion 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 [see Warnings and Precautions ( 5.2 ) ] . Impulse Control/Compulsive Behaviors 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 [see Warnings and Precautions ( 5.3 ) ] .
Infusion Site Reactions and Infections 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 fe… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
Medication Guide VYALEV TM (vye-uh-lev) (foscarbidopa and foslevodopa) injection, for subcutaneous use What is the most important information I should know about VYALEV? VYALEV may cause serious side effects, including: Falling asleep during activities of daily living and somnolence Hallucinations/psychosis, or confusion Impulse control, compulsive behaviors Infusion site reactions and infections Cardiovascular ischemic events Some of these problems may require discussion with your healthcare provider. See “What are the possible side effects of VYALEV?” for more information about side effects.
What is VYALEV? VYALEV is a prescription medicine used for treatment of advanced Parkinson’s disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
It is not known if VYALEV is safe and effective in children. Do not use VYALEV if you: take a medicine called a nonselective monoamine oxidase (MAO) inhibitor or have taken a nonselective MAO inhibitor within the last 14 days. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.
Before using VYALEV, tell your healthcare provider about all your medical conditions, including if you: feel sleepy or have fallen asleep suddenly during the day. have or have been seeing things that are not there, hearing sounds or feeling sensations that are not real (hallucinations) have or have had unusual urges such as problems with gambling, compulsive eating, compulsive shopping, and increased sex drive. have trouble controlling your muscles (dyskinesia). have low vitamin B6 levels have eye problems that cause increased pressure in your eye (glaucoma). drink alcohol.
Alcohol can increase the chance that VYALEV will make you feel sleepy or fall asleep when you should be awake. have or have had heart problems, an abnormal heart rate or have had a heart attack in the past. have or have had high blood pressure (hypertension). are pregnant or plan to become pregnant. It is not known if VYALEV can harm your unborn baby. are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take VYALEV.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using VYALEV with certain other medicines may affect each other and cause serious side effects. Especially tell your healthcare provider if you take: medicines used to treat high blood pressure (hypertension) medicines used to treat depression called nonselective monoamine oxidase (MAO) inhibitor or have taken one within the last 14 days dopamine D2 receptor antagonists (antipsychotics or metoclopramide), and isoniazid Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
How should I use VYALEV? See the detailed “Instructions for Use of VYALEV” that comes with VYALEV for information on how to prepare syringes of VYALEV for use in the pump , and how to properly throw away (dispose of) used syringes. See the detailed “Patient Instructions for Use of VYAFUSER Pump” that comes with your pump for complete instructions on how to use the delivery system.
Use VYALEV exactly as your healthcare provider tells you to use it. Only use VYALEV by yourself after you have been shown the right way to use VYALEV. Ask your healthcare provider if you have any questions.
Your prescribed dose of VYALEV will be programmed into your pump by a healthcare provider and should only be changed by your healthcare provider. Do not stop using VYALEV unless you are told to do so by your healthcare provider. Talk with your healthcare provider about what to do in case you are unable to use VYALEV infusion.
Keep a supply of backup oral Parkinson’s disease medicines that contain levodopa and carbidopa with you at all times. VYALEV is given continuously over 24 hours under the skin by a pump. VYALEV can be stopped for brief periods of time, such as when ta… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Because the decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available to the brain. The addition of carbidopa to levodopa reduces the peripheral effects (e.g., nausea and vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES 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).
Table 3. Change from Baseline to Week 12 in Primary and Key Secondary Measures Oral IR carbidopa-levodopa b (N=67) VYALEV (N=73) Primary Measure “On” time without troublesome dyskinesia (hours) a Baseline Mean (SD) 9.49 (2.62) 9.20 (2.42) Change from Baseline to Endpoint Week 12 Mean (SD) 0.85 (3.46) 3.36 (3.62) LS Mean (SE) of Change 0.97 (0.50) 2.72 (0.52) LS Mean (SE) of Difference 1.75 (0.65) P value 0.0083 Secondary Measure “Off” time (hours) a Baseline Mean (SD) 5.91 (1.88) 6.34 (2.27) Change from Baseline to Endpoint Week 12 Mean (SD) -0.93 (3.31) -3.41 (3.76) LS Mean (SE) of Change -0.96 (0.49) -2.75 (0.50) LS Mean (SE) of Difference -1.79 (0.63) P value 0.0054 LS = least squares; SD = standard deviation; SE = standard error. a Derived from Parkinson’s Disease (PD) diary. b Oral immediate release carbidopa-levodopa tablets.
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). Figure 1 . LS Mean Change (±SE) from Baseline in “On” Time Without Troublesome Dyskinesia over 12 Weeks * 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). Figure 2 .
LS Mean Change (±SE) from Baseline in “Off” Time over 12 Weeks * 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. A graph of a graph showing the results of a week Description automatically generated with m… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In rat, oral administration of carbidopa and levodopa for two years resulted in no evidence of carcinogenicity. VYALEV contains hydrazine, a degradation product of carbidopa. In published studies, hydrazine has been demonstrated to be carcinogenic in multiple animal species.
Increases in liver (adenoma, carcinoma) and lung (adenoma, adenocarcinoma) tumors have been reported with oral administration of hydrazine in mouse, rat, and hamster. Mutagenesis Carbidopa was positive in the in vitro Ames test, in the presence and absence of metabolic activation, and the in vitro mouse lymphoma tk assay in the absence of metabolic activation but was negative in the in vivo mouse micronucleus assay. In published studies, hydrazine was reported to be positive in in vitro genotoxicity (Ames, chromosomal aberration in mammalian cells, and mouse lymphoma tk ) assays and in the in vivo mouse micronucleus assay.
Impairment of Fertility In reproduction studies, no effects on fertility were observed in rats receiving carbidopa and levodopa.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In rat, oral administration of carbidopa and levodopa for two years resulted in no evidence of carcinogenicity. VYALEV contains hydrazine, a degradation product of carbidopa. In published studies, hydrazine has been demonstrated to be carcinogenic in multiple animal species.
Increases in liver (adenoma, carcinoma) and lung (adenoma, adenocarcinoma) tumors have been reported with oral administration of hydrazine in mouse, rat, and hamster. Mutagenesis Carbidopa was positive in the in vitro Ames test, in the presence and absence of metabolic activation, and the in vitro mouse lymphoma tk assay in the absence of metabolic activation but was negative in the in vivo mouse micronucleus assay. In published studies, hydrazine was reported to be positive in in vitro genotoxicity (Ames, chromosomal aberration in mammalian cells, and mouse lymphoma tk ) assays and in the in vivo mouse micronucleus assay.
Impairment of Fertility In reproduction studies, no effects on fertility were observed in rats receiving carbidopa and levodopa.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE VYALEV ™ [ vye-uh-lev ] (foscarbidopa and foslevodopa) injection , for subcutaneous use Read this Instructions for Use before you start using VYALEV and each time you get a new refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
This Instructions for Use contains information on how to prepare VYALEV. Before using VYALEV : Only use VYALEV by yourself after you have been shown the right way to use VYALEV and the delivery system (see the Patient Instructions for Use of VYAFUSER Pump ). Call your healthcare provider or call (866) 4-VYALEV or (866) 489-2538 for help or go to www.VYALEV.com.
How should I store VYALEV ? Keep the vials in the outer carton to protect the vials from breaking. Store VYALEV in the refrigerator between 36°F to 46°F (2°C to 8°C).
Record the date when VYALEV is first removed from the refrigerator in the space provided on the carton. VYALEV may be stored at room temperature up to a maximum of 86°F (30°C) for a single period of up to 28 days. After VYALEV has been stored at room temperature, do not return the medicine to the refrigerator.
If stored at room temperature, throw away (dispose of) VYALEV if not used within 28-days. Do not freeze. Do not shake.
If VYALEV is stored in the refrigerator, take one VYALEV vial out of the carton and out of the refrigerator 30 minutes before use. Use the VYALEV at room temperature or you may not get the right amount of the medicine. Keep VYALEV and all medicines out of the reach of children.
Important Information : Solution The VYALEV s olution color may have changes in color and does not affect how well the medicine works . It may be colorless, or may have different colors anywhere between light yellow and brown, possibly with purple or red tint. It also may become darker while in the syringe.
If refrigerated before use, remove the solution vial from refrigerated storage and allow to sit at room temperature out of direct sunlight for 30 minutes. Do not add any other liquid (dilute) the VYALEV solution or fill the syringe with anything other than what your healthcare provider prescribed. Do not use VYALEV if the expiration date (EXP:) shown on the carton and vial has passed.
Disposable Parts (Vial Adapter and Syringe) A new vial adapter must be used with each new vial of VYALEV. Do not use the VYALEV solution if it has been in the syringe for more than 24 hours. A.
T ransfer VYALEV from Solution V ial to Syringe 1. Make sure your work space is clean. Note: This will help to avoid contamination.
2. Gather supplies, including (see Figure A ) : - Solution vial - Syringe (not included in VYALEV carton) - Vial adapter (not included in VYALEV carton) - Alcohol pads (not included in VYALEV carton) Figure A Syringe Solution Vial Alcohol Vial Adapter Pads 3. Check over the parts for expiration and for any packaging damage.
This should include: • Solution vial (see Figure B) • Vial adapter • Syringe Check if the solution is the VYALEV solution prescribed by your healthcare provider. Do not use the VYALEV solution, vial adapter, or syringe if it is expired. Do not use any parts if their sterile packaging has been damaged before use.
Note: The product packaging for the infusion set, vial adapter, and syringe show that they are sterile and how they were sterilized. Figure B 4. Check over the contents of the VYALEV vial (see Figure C ) .
Check the following: No cloudiness of the liquid. No particles seen in the liquid. Figure C Do not use if the VYALEV solution is cloudy or contains flakes or particles.
Note: If refrigerated before use, remove the VYALEV solution vial from refrigerated storage and allow to sit at room temperature, out of direct sunlight, for 30 minutes. If refrigerated, do not warm VYALEV (in solution vial or syringe) in any way other than letting it warm at room temperature. For example, do not warm in a microwave or in hot water.
5. Wa… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2.1 ) 3/2026 Warnings and Precautions ( 5.7 ) 3/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC: 0074-0501-01 ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. VAYALEV ™ foscarbidopa and foslevodopa Injection 120 mg and 2,400 mg per 10 mL (12 mg and 240 mg per mL) For subcutaneous use 7 x 10 mL single-dose vials abbvie PRINCIPAL DISPLAY PANEL NDC: 0074-0501-01 ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. VAYALEV™ foscarbidopa and foslevodopa Injection 120 mg and 2,400 mg per 10 mL (12 mg and 240 mg per mL) For subcutaneous use 7 x 10 mL single-dose vials abbvie
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