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: Confirming & Adjusting Doses 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 explains how to confirm that doses have been programmed correctly prior to treatment initiation and how to adjust doses to meet your patients' unique needs. Please refer to the Full Prescribing Information for full VYALEV dosing guidance.

Text on screen: 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.vyalev_hcp_vyafuserpump.pdf.

VO: Access the pump menu and use the arrow keys to navigate to Clinician Settings and press SELECT.  Make sure you know the doses that you are confirming or adjusting. It’s important to have them readily available because, after 5 minutes of inactivity, the pump will exit Clinician Settings and changes will not be saved.

Text on screen: Access Clinician Settings MMake sure you know the doses that you are confirming or adjusting. After 5 minutes of inactivity, the pump will exit Clinician Settings and changes will not be saved. 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: If your patient has already initiated treatment, you will need to stop the continuous infusion before changing settings. If you forget to stop the pump, the display will prompt you to do so. Press YES to confirm that you wish to stop the pump.

Text on screen: Access Clinician Settings If your patient has already initiated treatment, stop the pump before adjusting therapy settings. 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: Enter your PIN and press NEXT to access Clinician Settings and change the dose parameters. Do not share the PIN with your patients as it is a safeguard to ensure that they cannot change the settings on their own. Similarly, always remember to press BACK to exit Clinician Settings before returning the pump to your patient to ensure that they cannot adjust any of the doses.

Text on screen: Access Clinician Settings If your patient has already initiated treatment, stop the pump before adjusting therapy settings. Enter your PIN and press NEXT to adjust dose parameters. Note: Clinician Settings will be locked after 5 incorrect PIN entries. 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: If you forgot the PIN, press YES and call VYALEV Complete at 1-866-489-2538 and give them the 3-digit activation code displayed on the pump. They will provide you with a 4-digit unlock code so you can reset your PIN. Don’t worry. Even if you get locked out of Clinician Settings, VYALEV will continue to be delivered at the previously programmed dose.

Text on screen: Access Clinician Settings If your patient has already initiated treatment, stop the pump before adjusting therapy settings. Enter your PIN and press NEXT to adjust dose parameters. Note: Clinician Settings will be locked after 5 incorrect PIN entries. If you forgot the PIN, call VYALEV Complete at 1-866-489-2538. Give them the 3-digit activation code displayed on the pump. Note: The 3-digit activation code will not remain on the screen after you press OK. 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: From the Clinician Settings menu, use the arrow to select SET RATE.

Text on screen: Confirming & Adjusting Continuous Hourly Infusion 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: To confirm a preprogrammed base continuous hourly infusion rate, review the current values and select NO to return to the Clinician Settings menu. To adjust the rate, select YES. 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: Confirming & Adjusting Continuous Hourly Infusion Rates Confirm/adjust the continuous hourly infusion rate(s). 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 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 do the same for the high and low continuous hourly infusion rates. If you do not wish to enable different flow rates, simply set them to the same value as the base continuous hourly infusion rate.

Text on screen: Confirming & Adjusting Continuous Hourly Infusion Rates Be sure to inform patients about how often they will need to change their syringe. 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: The extra dose provides patients with the flexibility to self-administer an additional dose. From the Clinician Settings menu, use the arrow keys to select SET EXTRA DOSE.

Text on screen: Confirming, Adjusting, or Disabling the Extra Dose Volume 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 confirm or adjust the extra dose volume. The extra dose volume ranges from 0.1 milliliters to 0.3 milliliters and can be adjusted in increments of 0.05 milliliters, which is equivalent to 8.5 milligrams of levodopa.

Text on screen: Confirming, Adjusting, or Disabling the Extra Dose Volume The extra dose volume setting allows your patient to self-administer an additional dose. Adjust the 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: The pump will prompt you to enter an extra dose lockout time to prevent patients from administering another extra dose until a set time has passed. Lockout times range from 1 to 24 hours and can be adjusted in 15-minute increments. To disable the patient’s ability to deliver an extra dose, set the volume to 0.00 milliliters.

Text on screen: Confirming, Adjusting, or Disabling the Extra Dose Volume The lockout time ranges from 1 to 24 hours in 15-minute increments. To disable the patient’s ability to deliver an extra dose, set the volume to 0.00 mL. 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. From Clinician Settings, use the arrow keys to select SET LOADING DOSE.

Text on screen: Confirming, Adjusting, or Disabling the Loading Dose Volume 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 confirm or adjust the loading dose volume. The loading dose volume ranges from 0.1 milliliters to 3.0 milliliters in increments of 0.1 milliliters, which is equivalent to 17 milligrams of levodopa.

Text on screen: Confirming, Adjusting, or Disabling the Loading Dose Volume 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. Adjust the 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: Enter a loading dose lockout time to prevent the delivery of a loading dose too soon after the last infusion. Loading dose lockout times range from 3 to 8 hours in increments of 1 hour. To disable the loading dose feature, set the volume to 0.00 milliliters.

Text on screen: Confirming, Adjusting, or Disabling the Loading Dose Volume The lockout time ranges from 3 to 8 hours in 1-hour increments. To disable the loading dose feature, set the volume to 0.00 mL. 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: Once all settings have been confirmed or adjusted, press BACK to exit Clinician Settings and return to the status screen before returning the pump to your patient. This ensures that your patient cannot adjust any of the dose volumes or infusion rates. Your patients will not have access to Clinician Settings. Instead, patients will select Change Rate in the menu to switch between base, low, and high continuous hourly infusion rates.

Text on screen: Exiting Clinician Settings Press BACK to exit Clinician Settings and return to the status screen. Patients cannot access Clinician Settings. Instead, they will select Change Rate to switch between base, low, and high 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 have now successfully confirmed or adjusted the VYALEV therapy settings on the pump. Keep listening for Important Safety Information.

Text on screen: You have now successfully confirmed/adjusted the VYALEV therapy settings on the pump. 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.