VO: VYALEV is a prescription medicine used for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. It may be administered continuously over 24 hours, under the skin through a wearable pump. This video will show you how to administer VYALEV in 5 steps. These steps are called the 5 Ps, and we’ll walk through each one together. Please see the Important Safety Information, Full Prescribing Information, Medication Guide, and Instructions for Use of VYALEV.
Text on screen: The 5 Ps of VYALEV Administration Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: First, let’s look at the VYALEV delivery system supplies and components.
Text on screen: Supplies and System Components Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: VYALEV arrives in a medication vial. The vial adapter connects the medication vial to the syringe. The syringe withdraws the medication from the vial and will then be used in the pump to deliver VYALEV. Note that the medication vial, vial adapter, and syringe will need to be replaced at least once per day.
Text on screen: Supplies and System Components Medication vial. Vial adapter. Syringe. Tubing. Cannula. Cannula insertion device. Actual VYALEV delivery system supplies and components may differ slightly in size and appearance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: The pump delivers VYALEV from the syringe through the tubing. The tubing connects to a small, soft tube called a cannula, which is placed just under the skin. The insertion device places the cannula into the insertion site. Note that the tubing, cannula, and insertion device will need to be replaced at least once every 3 days.
Text on screen: Supplies and System Components Medication vial. Vial adapter. Syringe. Tubing. Cannula. Cannula insertion device. Actual VYALEV delivery system supplies and components may differ slightly in size and appearance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Other components that come from the Specialty Pharmacy include a pump battery, a battery charger, an extra battery to charge while the pump is in use, and alcohol pads. Paper towels and a proper sharps disposal container will also be needed. AbbVie Nurse Ambassadors can share information on how to obtain a proper sharps disposal container.
Text on screen: Supplies and System Components Medication vial. Vial adapter. Syringe. Tubing. Cannula. Cannula insertion device. Actual VYALEV delivery system supplies and components may differ slightly in size and appearance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: A helpful way to remember how to administer VYALEV is to follow the 5 Ps.
Text on screen: Administration: The 5 Ps Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: One: Plan it out. Two: Prepare the syringe. Three: Prime the tubing. Four: Place the cannula. And five: Pump the medication.
Text on screen: Administration: The 5 Ps PLAN it out. PREPARE the syringe. PRIME the tubing. PLACE the cannula. PUMP the medication. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Let’s take a closer look at the 5 Ps, starting with number 1: Plan it out.
Text on screen: 1. Plan It Out Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: It’s important to practice a clean routine while following the 5 Ps. This means that hands, work surface, and VYALEV supplies are kept clean throughout each step.
Text on screen: Following the 5 Ps PLAN it out. Clean your hands and work surface. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Once your hands and work surface are cleaned, gather all the VYALEV supplies.
Text on screen: Following the 5 Ps PLAN it out. Clean your hands and work surface. Gather all the VYALEV supplies. Medication vial. Vial adapter. Syringe. Tubing. Cannula. Cannula insertion device. Actual VYALEV delivery system supplies and components may differ slightly in size and appearance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: You’re now ready for the second P: Prepare the syringe.
Text on screen: 2. Prepare the Syringe Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PREPARE the syringe. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Transfer all the medication from the vial to the syringe using the vial adapter.
Text on screen: Following the 5 Ps PREPARE the syringe. Transfer all the medication from the vial to the syringe using the vial adapter. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PREPARE the syringe. Transfer all the medication from the vial to the syringe using the vial adapter. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Next, attach the tip of the syringe to the tubing.
Text on screen: Following the 5 Ps PREPARE the syringe. Transfer all the medication from the vial to the syringe using the vial adapter. Attach the tip of the syringe to the tubing. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Then, place the full syringe inside the pump.
Text on screen: Following the 5 Ps PREPARE the syringe. Transfer all the medication from the vial to the syringe using the vial adapter. Attach the tip of the syringe to the tubing. Place the full syringe inside the pump. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Next is the third P: Prime the tubing.
Text on screen: 3. Prime the Tubing Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PRIME the tubing. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Priming means filling the infusion tubing with medication. Follow the prompts on the pump’s display screen to prime the tubing. Remember that the tubing must be primed before connecting the cannula to the body.
Text on screen: Following the 5 Ps PRIME the tubing. Fill the infusion tubing with medication before connecting the cannula to the body. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PRIME the tubing. Fill the infusion tubing with medication before connecting the cannula to the body. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Now, it’s time to continue to the fourth P: Place the cannula.
Text on screen: 4. Place the Cannula Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: The belly is the preferred infusion site, but other parts of the body can be used if directed by a healthcare professional. In a phase 1 study, healthy volunteers were administered VYALEV to different subcutaneous sites (ie, abdomen, arm, and thigh) using a 3-way crossover design. Pharmacokinetic (PK) analysis from this study showed that the 3 sites provided comparable carbidopa and levodopa exposure, suggesting VYALEV absorption is similar at the different infusion sites.
Text on screen: In a phase 1 study, healthy volunteers were administered VYALEV to different subcutaneous sites (ie, abdomen, arm, and thigh) using a 3-way crossover design. Pharmacokinetic (PK) analysis from this study showed that the 3 sites provided comparable carbidopa and levodopa exposure, suggesting VYALEV absorption is similar at the different infusion sites. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PLACE the cannula into the skin following aseptic technique. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: First, place the cannula into the skin using the insertion device. The cannula has a tiny, flexible tube that is inserted about a quarter of an inch into the skin to deliver the medication.
Text on screen: Following the 5 Ps PLACE the cannula into the skin following aseptic technique. Place the cannula into the skin using the insertion device. Note: Gently stretch the skin and ensure that the surface is flat and taut. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PLACE the cannula into the skin following aseptic technique. Place the cannula into the skin using the insertion device. Note: Gently stretch the skin and ensure that the surface is flat and taut. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Next, connect the tubing to the cannula.
Text on screen: Following the 5 Ps PLACE the cannula into the skin following aseptic technique. Place the cannula into the skin using the insertion device. Note: Gently stretch the skin and ensure that the surface is flat and taut. Connect the tubing to the cannula. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Now, you have reached the fifth and final P: Pump the medication.
Text on screen: 5. Pump the Medication Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: Follow the prompts on the display screen menu to deliver the medication. When the pump shows the word RUNNING in green in the top right corner of the pump display screen, the continuous infusion of VYALEV is in progress.
Text on screen: Following the 5 Ps PUMP the medication. Start the pump to deliver the medication. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
Text on screen: Following the 5 Ps PUMP the medication. Start the pump to deliver the medication. Demonstration belly is not to scale. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: As a reminder, the medication vial, vial adapter, and syringe will need to be replaced at least once per day. The tubing, cannula, and insertion device will need to be replaced at least once every 3 days.
Text on screen: Supplies and System Components Medication vial. Vial adapter. Syringe. Tubing. Cannula. Cannula insertion device. Actual VYALEV delivery system supplies and components may differ slightly in size and appearance. Please see Important Safety Information within this video. Please see Full Prescribing Information at https://www.rxabbvie.com/pdf/vyalev_pi.pdf and Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
VO: You have now successfully learned how to administer VYALEV. Keep listening for Important Safety Information.
Text on screen: You have now successfully learned how to administer 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 Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.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
VYALEVTM (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.
Please see Instructions for Use of VYALEV at https://www.rxabbvie.com/pdf/vyalev_ifu_solution.pdf.
REFERENCES:
1. VYALEV [package insert]. North Chicago, IL: AbbVie Inc.
2. VYALEV HCP Pump Instructions for Use. North Chicago, IL: AbbVie Inc.
3. Vented Vial Adapter Instructions for Use. West Pharmaceutical Services Inc.
4. NeriaTM Guard Insertion Device Instructions for Use. Convatec Inc.
