2 DOSAGE AND ADMINISTRATION Administration of AVLAYAH should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. 1) Obtain a baseline hemoglobin value in all patients.
1 ) Recommended AVLAYAH maintenance dosage for pediatric patients who weigh at least 5 kg is 15 mg/kg administered once weekly as an intravenous infusion over approximately 4 hours. 6 ) Initiate AVLAYAH treatment with a dose escalation regimen.
2 ) See the full prescribing information for dosage and administration modifications and monitoring. 3 ) See the full prescribing information for preparation and administration instructions. 1) ] . 1) ]. 2) ] . 3) ] . 2 Recommended Dosage The recommended starting dosage of AVLAYAH for pediatric patients weighing at least 5 kg is 3 mg/kg administered once weekly via intravenous infusion.
2) ] . Administer each dosage level for at least 4 weeks before escalating to the next dosage level. The recommended maintenance dosage of AVLAYAH for pediatric patients who weigh at least 5 kg is 15 mg/kg administered once weekly via intravenous infusion.
3) ] . , anaphylaxis) or a severe IAR, discontinue AVLAYAH and immediately initiate appropriate medical treatment. Consider the risks and benefits of re-administering AVLAYAH following a severe reaction. If the decision is made to re-administer AVLAYAH, re-evaluate pre-treatment medications, slow the infusion rate, and/or reduce the AVLAYAH dose.
2) ] . 2) ]. 2) ]. 4 Preparation Instructions Prepare AVLAYAH using polypropylene syringes and infusion bags composed of polyvinylchloride (PVC) or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP); infusion sets composed of PVC or PE; and filter membranes composed of polyethersulfone (PES).
Use aseptic technique during preparation. 2) ] . Round the number of vials up to the next whole number. 2) Remove the required number of AVLAYAH vials from the refrigerator and set aside for 15 to 30 minutes to allow vials to reach room temperature 20°C to 25°C (68°F to 77°F).
Do not use an external heat source. 2 mL of Sterile Water for Injection by slowly injecting the diluent onto the inside wall of each vial to avoid foaming. Do not inject forcefully or directly onto the lyophilized powder. 4) Gently swirl each vial to completely dissolve the lyophilized powder.
Do not invert or shake the vial. Each reconstituted vial will yield a concentration of 30 mg/mL of tividenofusp alfa-eknm. 5) Visually inspect the reconstituted solution in the vial(s) for particulate matter and discoloration. The solution should be clear to slightly opalescent and colorless to slightly brown/yellow, and free of visible particles.
Discard the reconstituted AVLAYAH solution if it is discolored, cloudy, or contains visible particulates. 6) ] in an infusion bag as follows: 1) Determine the appropriate volume of the infusion bag based on patient weight (see Table 2 ) and determine the volume of reconstituted AVLAYAH solution required for the calculated dose.
2) Prepare the infusion bag: a. Remove any airspace within the infusion bag. b. 9% Sodium Chloride Injection from the infusion bag equivalent to the volume of AVLAYAH to be added. 3) Slowly withdraw the required volume of reconstituted solution from the AVLAYAH vial(s).
Discard unused portion after each use; do not administer more than one dose from the vial. 9% Sodium Chloride Injection. Avoid introducing air into the infusion bag. 5) Gently invert the infusion bag to mix the solution. Do not shake. 6 mg/mL and 15 mg/mL.
5 Storage Instructions for the Reconstituted and Diluted Solutions Reconstituted Solution Do not shake. Do not freeze. If the reconstituted AVLAYAH vials are not diluted immediately, store at controlled room temperature between 20°C to 25°C (68°F to 77°F) for up to 4 hours.
Diluted Solution If the diluted AVLAYAH solution is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
After removal of the diluted solution from the refrigerator:
Completely infuse within 10 hours. Do not store back into the refrigerator. Discard the diluted solution if refrigerated more than 24 hours or if the diluted solution cannot be completely infused within 10 hours after removal from the refrigerator.
Do not shake. Do not freeze. 6 Administration Instructions 1) Administer AVLAYAH without delay as an intravenous infusion using only infusion sets composed of PVC or PE and filter membranes composed of PES. 2) If the diluted solution was refrigerated, allow solution to equilibrate to room temperature prior to infusion.
2 micron, in-line filter to administer AVLAYAH. 4) Infuse AVLAYAH over approximately 4 hours per the recommended infusion rates in Table 3. Increase the initial infusion rate to the subsequent infusion rate every hour based on patient tolerance.
Total infusion time should not exceed 8 hours. 5) In the absence of hypersensitivity reactions and IARs, AVLAYAH infusion rate can be gradually increased to complete the infusion in a minimum infusion duration of 3 hours based on patient tolerance.
9% Sodium Chloride Injection using the final infusion rate that was used to administer AVLAYAH. 7) Do not infuse AVLAYAH in the same intravenous infusion line with other products. 7) ] . The decision to have patients move to home infusion should be made after evaluation and recommendation by a healthcare provider.
In case of a missed dose or an IAR, contact a healthcare provider. 7 Missed Dose If an AVLAYAH dose is missed, skip the missed dose. Do not double a dose to compensate for a missed dose. Restart AVLAYAH treatment as soon as possible, maintaining the one-week interval between infusions thereafter.
6) ] .