How should VYALEV be stored?

Store VYALEV refrigerated at 2 °C to 8 °C (36 °F to 46 °F). Do not freeze. Instruct the patient to take one VYALEV vial out of the carton and out of the refrigerator 30 minutes prior to use. Tell the patient to use the product at room temperature or they may not get the right amount of medication. Do NOT warm the vial in a microwave or in hot water.

Can VYALEV be stored at room temperature?

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. Discard VYALEV if it is not used within the 28-day room-temperature period. Record the date when VYALEV is first removed from the refrigerator in the space provided on the carton.

What color should the VYALEV solution be?

VYALEV is a colorless to yellow to brown (may have a purple or red tint) and clear to slightly opalescent solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What if the VYALEV solution is cloudy or contains particles?

Do NOT use if the VYALEV solution is cloudy or contains flakes or particles.

What products can my patients use to clean the pump?

To clean the external, nonelectrical surfaces of the pump or the AC/mains adapter or charger, it is recommended that patients use a soft cloth lightly dampened with clean water and mild detergent or with diluted household bleach (1 part bleach to 9 parts water). Gently wipe the exterior surfaces of these components as needed (including parts of the pump that are exposed when the lid is open).

What happens if the pump gets wet?

Avoid spillage of liquids onto, or into, the pump. If the pump gets wet, immediately attempt to dry it using clean absorbent paper towels or a soft cotton cloth. Allow the pump to dry completely before use.

What if the device or any of its components are damaged or no longer working?

Call the 24/7 Hotline at 1-866-489-2538 to determine if a replacement is necessary and if the patient can continue to use the pump until a new one arrives. 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. Treatment with VYALEV may be resumed at any time by following the instructions for initiation of VYALEV.

How should my patients dispose of ancillary supplies?

Instruct your patients to dispose of insertion devices in a proper sharps disposal container or to follow local sharps disposal guidelines. Tell them they can dispose of all other used supplies in the household trash.

Will batteries be fully charged when patients receive the pump?

The batteries provided in the pump kit (carton) are not fully charged by the manufacturer. When the pump arrives, patients will need to charge the batteries. Batteries should be fully charged before use.

What is the device’s battery life?

The life of a fully charged battery varies depending on the continuous hourly infusion rate, but the charge will last for at least 24 hours. A new, fully charged battery will power the pump, even at the highest basal delivery rate, for at least 37 hours. Patients should always have one battery in use and one on the charger.

What if my patients need a new battery due to damage, malfunction, or loss?

Have the patient call their Specialty Pharmacy for more information.

What should my patients consider when traveling with VYALEV?

Patients can travel with the pump, but it should be kept away from direct sources of heat and high-moisture environments (eg, sauna, steam room). The system is designed to operate between 5 °C (41 °F) and 40 °C (104 °F). It may, however, be stored between -20 °C (-4 °F) and 60 °C (140 °F). After being stored at temperatures below 5 °C (41° F) or above 40 °C (104 °F), the system should remain unused at room temperature (20 °C [68 °F]) for at least 30 minutes before operating.

Can my patients take the delivery system through airport security?

The pump and battery charging system should not go through airport security scanners (ie, metal detectors, mm-Wave full-body scanners, and x-ray scanners). The patient should tell security personnel that they are using a medical device and request screening without passing through the scanner. A TSA Card will be provided to patients to help facilitate discussions with airport security.

Can my patients undergo MRI procedures while wearing the pump?

The VYALEV Pump is magnetic resonance unsafe and should be kept away from magnetic resonance environments, such as MRI scanner rooms. It is recommended that patients carry their provided MRI Card, show it to an HCP/MRI technician to alert them of their medical device, and remove the device before undergoing an MRI.

VYALEV® (foscarbidopa/foslevodopa) Frequently Asked Questions

How often does the patient need to change their VYALEV supplies?

The infusion set (cannula and tubing) should be replaced at least once every 3 days. Following interruptions of more than 1 hour, a new infusion set should be used and rotated to a different infusion site. NOTE: Instruct patients to have oral CD/LD available in the event that delivery of VYALEV is interrupted. If your patient is noticing redness or irritation at the infusion site, changing to a new infusion set and using a different infusion site may help.

Discard the syringe and any unused VYALEV in the syringe after the product has been in the syringe for 24 hours. The infusion set does not have to be changed every time a new syringe is used. If your patient uses more than one syringe daily (equivalent to 1700 mg levodopa), be sure to discuss the optimal timing to change the syringe.

Do not save VYALEV solution in the solution vial for later use. A new vial adapter must be used with each new solution vial.

What if there are air bubbles in the syringe?

If there are large air bubbles, they must be removed. Presence of air may affect dose delivery accuracy. Small bubbles are acceptable, and the air at the tip of the syringe (the head space) is expected. See Instructions for Use of VYALEV for more information.

What do I need to know about priming the tubing?

Prime the tubing by filling it with medication before connecting it to the body. Do not prime when the tubing and cannula are attached to the body. Make sure to hold the pump upside down so that the syringe tip faces up. Otherwise, the tubing will not prime. Your patient needs to prime every time they change the tubing.

What if my patients are having trouble inserting, connecting, or disconnecting the cannula?

When inserting the cannula, always remember to follow aseptic technique. First, take the insertion device in one hand and use the other hand to stretch the skin around the infusion site to create a taut, flat surface. Note the arrows on the insertion device that show where the tubing will be connected. Then, hold the insertion device against the insertion site. Firmly press the red button down until you hear a “click” to completely insert the cannula. Keep the device pressed against the skin for 5 seconds to ensure that the tape adheres. Then, carefully pull the insertion device away from the body and press the tape down around the cannula to ensure that it is secured to the skin.

When connecting the tubing to the cannula after priming, place a finger on the cannula housing while pushing the site connector straight in until you hear a "click."

When disconnecting the cannula, place a finger on the cannula housing and gently squeeze the sides of the site connector. Pull the site connector straight out from the cannula housing.

If it is difficult for your patient to disconnect the site connector from the cannula, advise them to apply a warm, soaking wet cloth to the site connector for at least 2 minutes to dissolve any dried medication that may be present. Then, the patient can try to disconnect again. If the patient is still unable to disconnect after several attempts, they can remove the cannula and replace the infusion set.

The patient can also inform their VYALEV Complete Nurse Ambassadors to receive supplemental education if they are having trouble inserting, connecting, or disconnecting the cannula.

What should my patients do if they see blood in the tubing or around the infusion site?

If the patient sees blood in the tubing and/or near the infusion site, they should replace the infusion set (both cannula and tubing) and choose a new infusion site.

What if the pump is disconnected and VYALEV delivery is interrupted?

Following interruptions of more than 1 hour, a new infusion set (insertion device, cannula, and tubing) should be used and rotated to a different infusion site. In addition, if VYALEV is interrupted for more than 3 hours, a loading dose may be administered. Instruct patients to have oral CD/LD available in the event that delivery of VYALEV is interrupted for extended periods.

What if my patients need additional supplies?

If patients need additional supplies, have them call their Specialty Pharmacy for more information.

Why are pump settings not being saved upon initial setup?

Once you begin setup, if 5 minutes of inactivity have elapsed, the pump will automatically exit initial setup and NONE of the values, which includes the PIN, will be saved. The values will be saved only after you have confirmed the PIN and all dose values. NOTE: Before creating the PIN, make sure you know all the values you plan to enter for the base, high, and low continuous hourly infusion rates, the extra dose, the loading dose, and lockout times.

How do I know what to set the high and low continuous hourly infusion rates to?

The high and the low rates are optional and can be programmed at your discretion.

If enabled by you, the high and low rates can give your patients flexibility throughout their day if there are changes in functional demand (eg, lowering the dose at night or increasing the dose for prolonged intense activity). Refer to the HCP Pump Instructions for Use and Full Prescribing Information for details.

Can I bypass setting up a high or low continuous hourly infusion rate?

Yes. High and low rates are optional and are not required to use the pump. To bypass the high and/or low rate, simply enter the same value as the base rate.

How can lockout times be adjusted?

The extra dose lockout time range is 1 hour to 24 hours (in 15-minute increments). The loading dose lockout time range is 3 hours to 8 hours (in 1-hour increments).

See HCP Pump Instructions for Use for more information on how to set and adjust lockout times.

Can I cancel a loading dose?

You may cancel the loading dose while it is being dispensed, but the pump will not display the loading dose option again until the lockout time has expired. If the loading dose is canceled, the pump will stop delivery and the continuous infusion will not automatically begin.

Can I cancel an extra dose?

You may cancel the extra dose while it is being dispensed. However, if the extra dose is canceled, it cannot be resumed. The next extra dose cannot be started until the lockout time has elapsed.

Do I need to select a PIN when setting up the pump?

Before the patient can use the pump, a PIN (only for HCP access) and base continuous infusion rate must be entered and confirmed. You’ll need to enter the PIN when setting or changing treatment parameters. The PIN should not be shared with the patient as it is a safeguard to ensure that they cannot change the settings on the pump.

Why isn’t my PIN being accepted?

The pump will not allow a PIN that contains the same 4 numbers or 4 consecutive numbers. For example, 2222 or 1234 will not work.

What should I do if I am locked out after entering the PIN incorrectly?

If the incorrect PIN is entered 5 times, or if you forgot the PIN and need to reset it, the Clinician Settings will be locked. Press OK to proceed and write down the 3-digit activation code that is displayed on the pump screen. This is the number that must be used to receive the unlock code.

To obtain the unlock code, call VYALEV Support at 1-866-489-2538. Explain that you need to reset the PIN and give them the 3-digit activation code that is displayed on the pump. They, in turn, will provide you with a 4-digit unlock code.

NOTE: If the pump is locked, it will still work but no changes can be made to the settings.

What do the alarms on the pump mean?

High-priority alarm with audible tones (red): Many high-priority alarms cause the pump to stop. The patient needs to take action to resolve the issue.

Low-priority alarm with audible tones (yellow): The pump is running, but if action is not taken as indicated in the alarm message, it may lead to a high-priority alarm.

Informational message with audible tones: Provides status information.

See Patient Pump Instructions for Use for more information on alarms.

How do you stop the alarms from sounding?

The pump’s audible alarms will continue to sound until they are acknowledged by pressing the OK button. To temporarily mute an alarm sound, press any button other than "OK" on the pump. When an alarm is muted, an icon will remain on the screen. To address the alarm and correct the issue, follow the prompts on the pump’s display screen. If the alarm is muted and not acknowledged, the audible signal will resume after 1 minute. To acknowledge an alarm, press “OK.” When acknowledged, the alarm sound will stop.