Vyalev

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) For subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. ( 2.2 , 2.3 , 2.4 ) See the Full Prescribing Information for calculation of the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose. ( 2.3 ) The maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa). ( 2.3 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including VYALEV, periodically during treatment, and as clinically indicated [see Warnings and Precautions 5.7 ] . If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with VYALEV while supplementing vitamin B6. 2. 2 Important Information For subcutaneous administration only. Patients selected for treatment with VYALEV should be capable of understanding and using the delivery system [see Healthcare Professional Instructions for Use of VYAFUSER Pump , and Patient Instructions for Use of VYAFUSER Pump ] themselves or with assistance from a caregiver. Patients should be trained on the proper use of VYALEV and the delivery system prior to initiating. 2. 3 Recommended Dosage VYALEV (foscarbidopa and foslevodopa) is administered as a subcutaneous infusion with the VYAFUSER pump [ see Dosage and Administration ( 2.4 ), Healthcare Professional Instructions for Use of VYAFUSER Pump , and Patient Instructions for Use of VYAFUSER Pump ] . VYALEV Base Continuous Dosage and Hourly Infusion Rate The continuous infusion rate is based on total levodopa dosage (TLD). The hourly base continuous infusion rate (mL/hr) = [(TLD x 1.3) / 240] / [number of hours the patient is typically awake (e.g., 16 hours)], as shown in the steps below. Step 1: Calculate the TLD for the levodopa-containing medications that VYALEV is replacing. All dosages should be converted to the equivalent dosage of immediate-release levodopa to obtain the TLD. Prescribers should adjust the total dose of levodopa-containing products for COMT inhibitor use. See the Prescribing Information for the respective drugs for conversions or adjustments. Do not include rescue or as needed levodopa or any other anti-Parkinsonian medication or therapy, including medications taken outside of awake time (e.g., night-time dosing) in this calculation. Step 2: Determine the total daily dosage (mg) of VYALEV foslevodopa component by multiplying the TLD by 1.3. The conversion factor takes into account the molecular weight and bioavailability of foslevodopa compared to levodopa. Step 3: Determine the total daily volume (mL) of VYALEV by dividing the total daily dosage (mg) of VYALEV by 240. Each 1 mL of VYALEV contains 240 mg of foslevodopa. Step 4: Determine the hourly base continuous infusion rate of VYALEV by dividing the total daily volume (mL) of VYALEV by the number of hours the patient is typically awake (e.g., 16 hours). VYALEV may be administered over the patient’s waking hours or may be administered for 24 hours. See Dosage and Administration ( 2.4 ) for adjustment of and alternate infusion rates for lower overnight dosages. Maximum Dosage The maximum recommended daily dosage of VYALEV is 3,525 mg of the foslevodopa component (equivalent to approximately 2,500 mg levodopa). Optional Loading Dose 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, a loading dose can be administered immediately prior to starting or re-starting the base continuous hourly infusion. Loading doses can be administered either with VYALEV or patients can continue using oral immediate-release carbidopa/levodopa tablets. 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. If VYALEV is used for the loading dose, multiply the first morning dose of oral immediate release levodopa by 1.3 and divide by 240 to determine the loading dose of VYALEV. The pump is capable of delivering a loading dose ranging from 0.1 mL to a maximum of 3 mL, in increments of 0.1 mL. Extra Dose An extra dose volume can be programmed to 1 of 5 options (see Table 1). The “extra dose” feature is limited to no more than 1 extra dose per hour. If 2 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 (refer to the Healthcare Professional Instructions for Use of VYAFUSER Pump details). Table 1. Extra Dose Option for VYALEV VYALEV extra dose volume Approximate equivalent levodopa dose * 0.1 mL 17 mg 0.15 mL 25.5 mg 0.2 mL 34 mg 0.25 mL 42.5 mg 0.3 mL 51 mg * See Step 1 2. 4 Preparation and Administration Instructions Patients should be trained on the proper use of VYALEV and the delivery system prior to initiating treatment with VYALEV and, as necessary, thereafter [see Dosage and Administration ( 2.3 ) and the Patient Instructions for Use of VYAFUSER Pump ] . Preparation Use aseptic technique. Use sterile, single-patient-use infusion components (syringe, infusion set, and vial adapter) qualified for use with the pump to infuse VYALEV. Do not dilute. Do not mix VYALEV with other products. The medication vials are for single dose only. The entire contents of a VYALEV vial should be transferred into a syringe for administration. Do not withdraw a partial portion of the vial contents. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths ( 3 ) ] . The infusion set (cannula) can remain in place for up to 3 days when VYALEV is infused continuously. Administration Site Selection Administer VYALEV subcutaneously, preferably in the abdomen, avoiding the area with a 2-inch radius from the navel. Rotate the infusion site and use a new infusion set at least every 3 days. Select new infusion sites at least 1 inch from sites used within the previous 12 days. Do not infuse VYALEV into areas where the site is tender, bruised, red, or hard to the touch. Infusion Flow Rates Adjustment: Infusion rates may be adjusted in increments of 0.01 mL/hr (which is equivalent to approximately 1.7 mg of levodopa/hour). Alternative Flow Rates: The healthcare professional has the option to enable and pre-program the pump with 2 alternative continuous infusion rates (Low/High) that the patient may select to account for changes in functional demand (e.g., lowering the dosage at night or increasing the dose for prolonged intense activity) (see the Healthcare Professional Instructions for Use of VYAFUSER Pump ) . Discarding VYALEV and Syringe Discard the vial after transfer of the product to the syringe. Discard the syringe and any unused VYALEV in the syringe after the product has been in the syringe for 24 hours. 2. 5 Interruption of Therapy Prescribing a backup oral carbidopa and levodopa product is recommended in the event that delivery of VYALEV is interrupted, which may result in underdosing. Sudden discontinuation or rapid dose reduction of VYALEV, without administration of alternative dopaminergic therapy, should be generally avoided [see Warnings and Precautions ( 5.5 )]. Following interruptions of more than 1 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 3 hours, the patient may also self-administer a loading dose, if enabled by their healthcare professional [see Dosage and Administration ( 2.3 )] .

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