VYALEV 240 MG — DIN 02537702

What is VYALEV?

VYALEV 240 MG contains FOSLEVODOPA : 240 MG FOSCARBIDOPA : 12 MG. It is listed in the Health Canada Drug Product Database under DIN 02537702, held by ABBVIE CORPORATION, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 05-Feb-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is VYALEV used for?

VYALEV (foslevodopa/foscarbidopa solution) is indicated for: the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson's disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper-/dyskinesia despite optimized treatment with available combinations of Parkinson's medicinal products. VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson's disease.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

VYALEV is administered as a continuous subcutaneous infusion, 24-hours per day, using the VYAFUSER™ infusion pump. Only the VYAFUSER pump should be used (refer to the pump instructions for use for details) using sterile, single-patient-use infusion components (syringe, infusion set, and vial adapter) that are qualified for use and provided separately. Refer to the Healthcare Professional Instructions for Use of the VYAFUSER Pump and Preparing VYALEV Solution Instructions for Use for additional information on ancillaries. Do not administer intravenously or intramuscularly. Periodic evaluation of hepatic, hematopoietic, cardiovascular, and renal function is recommended during dosage optimization and during extended therapy with VYALEV. In case of suspected or diagnosed dementia with a decreased confusion threshold, patient's pump should be handled by the nursing staff or a caregiver and the benefit/risk of continued treatment with VYALEV should be re-assessed. The recommended starting infusion rate of VYALEV is determined by calculating the levodopa equivalents (LE) from all levodopa-containing medications and catechol-O-methyl transferase (COMT)-inhibitors taken during daytime hours and then increasing it to account for a 24-hour administration (see Initiation of Treatment). The dose may be adjusted to reach a clinical response that maximizes the functional “On” time and minimizes the number and duration of "Off" episodes and "On" episodes with troublesome dyskinesia. The lowest efficacious dose should be used to minimize the risk of adverse events. The maximum recommended daily dose of foslevodopa is 6000 mg (or 25 mL of VYALEV per day equivalent to approximately 4260 mg levodopa per day). Note that a limited number of patients were exposed to daily doses higher than 4000 mg of foslevodopa. VYALEV replaces levodopa-containing medications and COMT-inhibitors. If required, other classes of medicinal products for Parkinson's disease can be taken concurrently. Patients selected for treatment with VYALEV should be capable of understanding and using the delivery system themselves or with assistance from a caregiver. Patients should be trained on the proper use of VYALEV and the delivery system (see 4.4 Administration) prior to initiating treatment with VYALEV and, as necessary, thereafter. Three steps are required to initiate treatment with VYALEV (by the prescriber): Step 1: Calculate the LE based on the levodopa-containing medications and COMT-inhibitors taken during the patient's awake time. Step 2: Determine the hourly infusion rate of VYALEV to be administered over the 24 hours. Step 3: Determine the volume of the loading dose. A loading dose can be administered immediately prior to commencing the hourly infusion to quickly achieve symptomatic control when starting VYALEV therapy in an "Off" state (or if the pump has been off for more than three hours). If the loading dose is enabled, it should be as close as possible to the amount of LE from the first morning dose of PD therapy that the patient used to take before commencing VYALEV. Loading doses can be administered either via the pump or using oral immediate-release levodopa/carbidopa tablets. The healthcare professional may adjust the hourly infusion rate to achieve the optimal clinical response for the patient. The hourly infusion rate should be delivered continuously over the 24-hour daily infusion period. If desired, the healthcare professional can program and enable two alternative hourly infusion rates (Low/High). All infusion rates may be adjusted in increments of 0.01 mL/hr (which is equivalent to approximately 1.7 mg of levodopa/hour) and should not exceed 1.04 mL/hr (which is equivalent to approximately 177 mg of levodopa/hour or approximately 4260 mg levodopa per day [6000 mg of foslevodopa per day]). The pump incorporates secure access to dose configuration to prevent patients from making changes to their pre-programmed flow rates or Extra Dose functionality. VYALEV can be administered alone or, if necessary, with other concurrent medicinal products for Parkinson's disease, based on the judgment of the healthcare professional. A reduction in other concomitant medications for Parkinson's disease, followed by an adjustment in VYALEV dosage, may be considered during VYALEV infusion. The pump also allows for two alternative infusion rate options to be programmed for patient use (Low/High). The alternative infusion rates must be enabled and pre-programmed by the healthcare professional and may be selected by patients to account for changes in functional demand, e.g., lowering the dosage at night-time or increasing the dose for prolonged intense activity (refer to the pump instructions for use for details). If enabled by their healthcare professional, patients may self-administer an Extra Dose to manage acute "Off" symptoms experienced during continuous infusion. The Extra Dose volume can be chosen from five options (see Table 4). The Extra Dose feature is limited to no more than one extra dose per hour. If five or more extra doses are used by the patient during the 24-hour/day treatment period, a revision of the Base continuous infusion rate should be considered. The ability to enable this function, as well as the minimum time required between extra doses, is determined by the healthcare professional and cannot be modified by the patient (refer to the pump instructions for use for details on programming the Extra Dose feature). A sudden or unusual deterioration in treatment response may indicate an obstruction/blockage of the device (pump or infusion set) or other device-related problems and should be investigated. VYALEV is administered subcutaneously in the abdomen, avoiding a 5-cm radius area from the navel. Use aseptic technique when preparing and administering VYALEV (refer to Instructions for Use for how to prepare VYALEV Solution). The infusion set (cannula) can remain in place for up to three days when VYALEV is infused continuously. Rotate the infusion site and use a new infusion set at least every three days. It is recommended that new infusion sites be at least 2.5 cm from sites used within the previous 12 days. VYALEV should not be infused into areas where the site is tender, bruised, red or hard to the touch. For administration of VYALEV, only the VYAFUSER infusion pump should be used (refer to the pump Instructions for Use for details) using sterile, single-use infusion components (syringe, infusion set, and vial adapter) qualified for use. Patients should be trained on the proper use of VYALEV and the delivery system (pump, solution vial, vial adapter, syringe, infusion set, carrying accessory, rechargeable battery, and charger) prior to initiating treatment with VYALEV and, as necessary, thereafter. If any unusual signs appear (redness, pain, swelling) at the infusion site, or worsen, the patient should be advised to consult a healthcare professional. The medication should be stored and handled as described in 11 STORAGE, STABILITY AND DISPOSAL and Instructions for Use for Preparing Solution. Sudden discontinuation or rapid dose reduction of VYALEV, without administration of alternative dopaminergic therapy, should be generally avoided (see 7 WARNINGS AND PRECAUTIONS, Neuroleptic Malignant Syndrome). Do not swim, bathe, or shower with the pump. VYALEV can be interrupted without further actions for brief periods of time, such as when the patient is taking a shower. For interruptions of more than one hour, a new infusion set (tubing and cannula) should be used and rotated to a different infusion site. If the infusion has been interrupted for longer than three hours, the patient may self-administer a loading dose, if enabled by their healthcare professional, to quickly re-establish symptom control. The infusion set should be replaced and rotated if the adhesive becomes loose. If treatment with VYALEV is interrupted for a prolonged period of time (> 24 hours) or permanently discontinued, the healthcare professional should determine appropriate alternative dopaminergic treatment (e.g., oral levodopa/carbidopa). Treatment with VYALEV may be resumed at any time following instructions as for initiation of VYALEV (see 4.2 Recommended Dose and Dosage Adjustment, Initiation of Treatment).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

VYALEV is contraindicated in patients with: hypersensitivity to foslevodopa, levodopa, foscarbidopa, or carbidopa or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. narrow-angle glaucoma. clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma). concomitant use of non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors. These inhibitors must be discontinued at least two weeks prior to initiating therapy with VYALEV. VYALEV may be administered concomitantly with the manufacturer's recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride) (see 9.1 Serious Drug Interactions; 9.4 Drug-Drug Interactions). undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma (see 7 WARNINGS AND PRECAUTIONS, Skin). concomitant administration of a sympathomimetic amine (e.g., epinephrine, norepinephrine, isoproterenol) (see 9.1 Serious Drug Interactions; 9.4 Drug-Drug Interactions). conditions in which medication with adrenergic activity are contraindicated, e.g., pheochromocytoma, hyperthyroidism and Cushing's syndrome.

Warnings and precautions

Sudden Onset of Sleep: Patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents. Although some of the patients reported somnolence while on levodopa, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events were NOT limited to initiation of therapy. Patients should also be advised that sudden onset of sleep has occurred without warning signs and should be specifically asked about factors that may increase the risk with VYALEV such as concomitant medications or the presence of sleep disorders. Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence) with levodopa, physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking VYALEV. If drowsiness or sudden onset of sleep should occur, patients should be informed to immediately contact their physician. Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents, therefore, symptoms may not be alleviated by substituting these products. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. Currently, the precise cause of this event is unknown. It is known that many Parkinson's disease patients experience alterations in sleep architecture, which results in excessive daytime sleepiness or spontaneous dozing, and that dopaminergic agents can also induce sleepiness. Infusion Site Reactions and Infections: A high proportion of patients have developed infusion site reactions and infections during the clinical development and on multiple occasions for some of them. In a few patients, infusion site cellulitis or abscess led to sepsis which required hospitalization. Sepsis can potentially be life-threatening and must be recognized and treated in a timely manner. Refer to the Patient educational material (Patient Guide) for proper use of VYALEV. The guide can be accessed at abbviecare.ca.