Mosunetuzumab

Important Dosing Information LUNSUMIO VELO and LUNSUMIO have different dosage and administration instructions [see Dosage and Administration and Warnings and Precautions ]. LUNSUMIO VELO is for subcutaneous use only. Check the product label to ensure that the correct formulation (LUNSUMIO VELO or LUNSUMIO) is being prescribed and administered.

Do not substitute LUNSUMIO VELO for or with LUNSUMIO. Administer LUNSUMIO VELO to well-hydrated patients. Premedicate before each dose in Cycle 1 [see Dosage and Administration ] . LUNSUMIO VELO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1 and 5.2) ] .

Preparation and Administration If the LUNSUMIO VELO dose is not administered immediately, refer to "Storage of Prepared Syringe" section below. To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is LUNSUMIO VELO for subcutaneous administration. A peel-off label is provided on the LUNSUMIO VELO Prescribing Information that should be attached to the final prepared syringe.

Remove the peel-off label from the Prescribing Information in the LUNSUMIO VELO carton before discarding the carton. Affix the peel-off label to the prepared LUNSUMIO VELO syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if the solution is discolored, or cloudy, or if foreign particles are present. Each LUNSUMIO VELO 5 mg/0.5 mL and 45 mg/mL vial are supplied as ready-to-use solution that do not need dilution prior to subcutaneous administration. LUNSUMIO VELO vials are for one-time use in one patient only. No incompatibilities between LUNSUMIO VELO and polypropylene or polycarbonate syringe material, stainless-steel transfer and injection needles, and polyethylene or polypropylene syringe closing caps have been observed.

Preparation of the Syringe Use aseptic technique to prepare LUNSUMIO VELO. Select the appropriate strength vial based on the prescribed dose. Withdraw the required volume of LUNSUMIO VELO solution from the vial with a syringe and an appropriately sized transfer needle (18G to 21G recommended). The smallest syringe that can accurately deliver the injection volume should be used.

Discard any unused portion left in the vial. Remove the transfer needle and attach an appropriately sized injection needle (25G to 30G recommended). Apply peel-off label from the Prescribing Information to the prepared drug product. Once transferred from the vial to the syringe, LUNSUMIO VELO solution for injection should be injected immediately because LUNSUMIO VELO solution for injection does not contain any antimicrobial-preservative.

Administration Inject the required volume of LUNSUMIO VELO into the subcutaneous tissue of the abdomen or thigh, changing the site of injection with each dose. Do not inject into tattoos, moles, scars or areas where the skin is red, bruised, tender, hard, or not intact. The dose should be administered subcutaneously over approximately 30 seconds to 1 minute.

Storage of Prepared Syringe The prepared syringe should be used immediately. If not used immediately, replace the transfer needle with a syringe closing cap. Do not attach an injection needle. The capped syringe can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 32 hours protected from light and/or at 9°C to 25°C (37°F to 77°F) for up to 8 hours at ambient light.

Once removed from refrigerated storage, the solution can be equilibrated to ambient temperature up to 25°C (77°F) prior to administration. Do not warm LUNSUMIO VELO in any other way.