VO: VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV may be administered continuously over 24 hours via subcutaneous infusion and replaces all levodopa-containing medications, as well as any catechol-O-methyltransferase (COMT) inhibitors a patient is taking. Please see Important Safety Information within this video.

Text on screen: Initial Dose Programming Please see VYALEV HCP Pump Instructions for Use. The maximum recommended daily dosage of VYALEV is 3525 mg of the foslevodopa component (equivalent to approximately 2500 mg levodopa). Prescribing a backup oral carbidopa and levodopa product is recommended in the event that delivery of VYALEV is interrupted, which may result in underdosing. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: This video will show you how to program the pump and use its customizable dosing features to help meet your patients' unique needs. If you elected to have the Specialty Pharmacy preprogram the pump, you can skip this video and go straight to the Confirming & Adjusting Doses video.

Text on screen: Please see Important Safety Information within this video. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Before you begin, you need to determine your patient’s dose. You can do this using the Full Prescribing Information or the VYALEV Dosing Calculator on VyalevCalculator.com.

Text on screen: BEFORE YOU BEGIN Before you begin, determine your patient’s dose using the Full Prescribing Information or the VYALEV Dosing Calculator on VyalevCalculator.com. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Be prepared to program all infusion rates when your patient comes in to initiate treatment with VYALEV. If the pump is inactive for 5 minutes during initial programming, all dose values and the PIN will be lost.

Text on screen: BEFORE YOU BEGIN Before you begin, determine your patient’s dose using the Full Prescribing Information or the VYALEV Dosing Calculator on VyalevCalculator.com. Be prepared to program all infusion rates in one sitting. If the pump is inactive for 5 minutes, all dose values and the PIN will be lost. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: First, insert a fully charged battery. The pump will automatically turn on. Because VYALEV may be delivered 24/7, always install a fully charged battery.

Text on screen: Prepare Pump Insert a fully charged battery. Make sure your patient brings in a fully charged battery on Start Day. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Upon first use, the pump will prompt you to select a 4-digit PIN. You will need this PIN to set or change treatment parameters, so it is important to remember it. Do not share this PIN with your patients. The PIN is a safeguard to ensure that the patient cannot change the settings.

Text on screen: Initial Setup Set a 4-digit PIN. Note: The pump will not allow a PIN that contains 4 repeating digits or consecutive numbers (eg, 2222 or 1234). Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Use the arrow and selection keys to select the PIN. Please note: the pump will not allow a PIN that contains 4 repeating digits or consecutive numbers. Choose a PIN you can easily remember. You may use the same PIN for multiple patients. Confirm the PIN by pressing OK and re-entering the PIN. Press NEXT to save the PIN, then press OK to continue.

Text on screen: Initial Setup Set a 4-digit PIN. Note: The pump will not allow a PIN that contains 4 repeating digits or consecutive numbers (eg, 2222 or 1234). Choose a PIN you can easily remember. You may use the same PIN for multiple patients. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: The pump will first prompt you to set the base continuous hourly infusion rate.

Text on screen: Setting Continuous Hourly Infusion Rates Set the base continuous hourly infusion rate. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Use the arrow keys to choose the dose that you have previously determined and press NEXT to set the base continuous hourly infusion rate. Rates range from 0.15 to 1.25 milliliters per hour and can be set in increments of 0.01 milliliters per hour, which is equivalent to 1.7 milligrams per hour of levodopa.

Text on screen: Setting Continuous Hourly Infusion Rates Set the base continuous hourly infusion rate. Rates range from 0.15 to 1.25 mL/hr and can be set in increments of 0.01 mL/hr (equivalent to 1.7 mg/hr of levodopa). The maximum recommended daily dosage of VYALEV is 3525 mg of the foslevodopa component (equivalent to approximately 2500 mg levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Next, you will be prompted to set high and low continuous hourly infusion rates. If enabled, these rates allow your patient flexibility to adjust their dose throughout their day. High and low rates can be disabled. If you wish to disable them, simply set them to the same value as the base continuous hourly infusion rate.

Text on screen: Setting Continuous Hourly Infusion Rates Set high/low continuous hourly infusion rates (optional). If you set high/low rates, your patient will have the flexibility to increase/decrease their dose. High and low hourly infusion rates can be disabled. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: After you have added values for the base, high, and low rates, press CONFIRM and follow the prompts to program the extra dose.

Text on screen: Setting Continuous Hourly Infusion Rates Set high/low continuous hourly infusion rates (optional). If you set high/low rates, your patient will have the flexibility to increase/decrease their dose. High and low hourly infusion rates can be disabled. Confirm rates. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: You may want to set an extra dose volume to give your patient the flexibility to self-administer an additional dose. Press NO to skip extra dose setup and disable the extra dose. Press YES to set up extra dose parameters and enable the extra dose.

Text on screen: Setting the Extra Dose Volume (Optional) The extra dose volume setting allows your patient to self-administer an additional dose. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Use the arrow keys to set the extra dose volume. Choose an extra dose volume from 0.1 to 0.3 milliliters in increments of 0.05 milliliters, which is equivalent to 8.5 milligrams of levodopa.

Text on screen: Setting the Extra Dose Volume (Optional) The extra dose volume setting allows your patient to self-administer an additional dose. Choose an extra dose volume from 0.1 to 0.3 mL in increments of 0.05 mL (equivalent to 8.5 mg of levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: As a safety feature, the extra dose functionality is limited to no more than 1 extra dose per hour. Set a lockout time from 1 to 24 hours in 15-minute increments by using the arrow keys. Then press NEXT.

Text on screen: Setting the Extra Dose Volume (Optional) The extra dose volume setting allows your patient to self-administer an additional dose. Choose an extra dose volume from 0.1 to 0.3 mL in increments of 0.05 mL (equivalent to 8.5 mg of levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. The lockout time ranges from 1 to 24 hours in 15-minute increments. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Review and confirm your extra dose settings and follow the prompts to program the loading dose.

Text on screen: Setting the Extra Dose Volume (Optional) The extra dose volume setting allows your patient to self-administer an additional dose. Choose an extra dose volume from 0.1 to 0.3 mL in increments of 0.05 mL (equivalent to 8.5 mg of levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. The lockout time ranges from 1 to 24 hours in 15-minute increments. Confirm the extra dose volume and lockout time. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: A loading dose can be administered 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. Press NO to skip loading dose setup and disable the loading dose. Press YES to set up loading dose parameters and enable the loading dose.

Text on screen: Setting the Loading Dose Volume (Optional) A loading dose can be administered 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. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Use the arrow keys to set the loading dose volume. 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. Choose a loading dose volume from 0.1 milliliters to 3.0 milliliters in increments of 0.1 milliliters, which is equivalent to 17 mg of levodopa.

Text on screen: Setting the Loading Dose Volume (Optional)  A loading dose can be administered 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. 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. Choose a loading dose volume from 0.1 mL to 3.0 mL in increments of 0.1 mL (equivalent to 17 mg of levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: To prevent delivery of a loading dose too soon after the last infusion, enter a loading dose lockout time from 3 to 8 hours in increments of 1 hour. Use the arrow keys to set the lockout time, then press NEXT.

Text on screen: Setting the Loading Dose Volume (Optional) A loading dose can be administered 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. 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. Choose a loading dose volume from 0.1 mL to 3.0 mL in increments of 0.1 mL (equivalent to 17 mg of levodopa). Please refer to the Full Prescribing Information for full VYALEV dosing guidance. The lockout time ranges from 3 to 8 hours in 1-hour increments. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: Now that you have programmed and confirmed your dose settings, the pump will automatically exit the initial setup and display the status screen in stopped mode. Always verify that dose parameters have been set correctly and ensure that you have exited Clinician Settings prior to dispensing the pump to your patient.

Text on screen: Setting the Loading Dose Volume (Optional) The pump will automatically exit the initial setup and display the status screen in stopped mode. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

VO: You have successfully completed the initial setup of the VYALEV Pump. You are now ready to initiate your patient on VYALEV. Keep listening for Important Safety Information.

Text on screen: You have successfully completed the initial setup of the VYALEV Pump. You are now ready to initiate your patient on VYALEV. Keep listening for Important Safety Information. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and VYALEV HCP Pump Instructions for Use at https://www.rxabbvie.com/pdf/vyalev_hcp_vyafuserpump.pdf.

Text on screen (with VO to match): IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION

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

IMPORTANT SAFETY INFORMATION

VYALEV^TM (foscarbidopa/foslevodopa) is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension.

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 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. For this reason, prescribers should continually assess VYALEV-treated patients for drowsiness or sleepiness. Advise patients about the potential to develop drowsiness with VYALEV and ask about factors that may increase risk of somnolence. Consider discontinuing VYALEV in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. 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.

There is an increased risk for hallucinations and psychosis in patients taking VYALEV. 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. Patients with a major psychotic disorder should not be treated with VYALEV.

Patients may experience intense urges while on VYALEV. 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 on VYALEV. Consider reducing the dose or discontinuing VYALEV if a patient develops such urges.

VYALEV can cause infusion site reactions and infections. Various types of reactions at the infusion site have been reported, including erythema, pain, edema, nodules, warmth, swelling, and others. The most frequent infusion site infection reported was cellulitis. If an infection is suspected at the infusion site, the cannula should be removed. In such a case, either a new cannula should be placed at a new infusion site or, in the event of a prolonged interruption, prescribe an oral carbidopa/levodopa product until the patient is able to resume VYALEV.

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, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of VYALEV.

VYALEV may cause or exacerbate dyskinesias, which may require a dose reduction of VYALEV or other medicines used to treat Parkinson’s disease.

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.

Monitor patients with glaucoma after starting VYALEV as it may cause increased intraocular pressure.

Drug Interactions: The use of nonselective MAO inhibitors is contraindicated. Selective MAO-B inhibitors may be associated with orthostatic hypotension. Concurrent administration with antihypertensives can cause symptomatic postural hypotension, which may require a dose adjustment of the antihypertensive. Coadministration with dopamine D2 antagonists or isoniazid may reduce the effectiveness of VYALEV.

The most common adverse reactions for VYALEV that occurred in ≥3% of patients, and at least 2% difference from oral immediate-release carbidopa/levodopa, were infusion/catheter site reactions, infusion/catheter site infections, hallucinations, dyskinesia, On and Off phenomenon, balance disorder, constipation, peripheral swelling, agitation, insomnia, psychotic disorder, and dyspnea.

VYALEV (foscarbidopa and foslevodopa) injection for subcutaneous use is available in a 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) solution.

Please see accompanying full Prescribing Information or visit https://www.rxabbvie.com/pdf/vyalev_pi.pdf.