Inebilizumab

Assessment and Premedication Before Every Infusion Infection Assessment Prior to every infusion of UPLIZNA, determine whether there is an active infection. In case of active infection, delay infusion of UPLIZNA until the infection resolves [see Warnings and Precautions ]. Premedication Table 1 shows premedication to administer prior to each infusion of UPLIZNA to reduce the frequency and severity of infusion reactions [see Warnings and Precautions ]. [See table below.] antipyretic oral acetaminophen 500 mg to 650 mg 30 to 60 minutes

Recommended Dosage and Administration NMOSD, IgG4-RD, and gMG UPLIZNA is administered as an intravenous infusion (see Table 2 ). The recommended dosage is: Initial dose: 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion. Subsequent doses (starting 6 months from the first infusion): single 300 mg intravenous infusion every 6 months.

Administration UPLIZNA must be diluted prior to administration [see Dosage and Administration ]. Prior to the start of the intravenous infusion, the prepared infusion solution should be at room temperature. Administer UPLIZNA under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage potential severe reactions such as serious infusion reactions [see Warnings and Precautions ].

Administer the prepared solution intravenously via an infusion pump at an increasing rate to completion, approximately 90 minutes, according to the schedule in Table 2. Administer through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter. [See table below.] Monitor the patient closely for infusion reactions during and for at least one hour after the completion of the infusion.

Preparation and Storage of Infusion Solution Preparation Visually inspect UPLIZNA solution for particulate matter and discoloration [see Dosage Forms and Strengths ]. If the solution is cloudy, discolored, or it contains discrete particulate matter, do not use and contact the manufacturer (1-800-772-6436). Do not shake the vial.

Obtain an intravenous bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. Do not use other diluents to dilute UPLIZNA. Withdraw 10 mL of UPLIZNA from each of the 3 vials contained in the carton and transfer a total of 30 mL into the 250 mL intravenous bag. Mix diluted solution by gentle inversion. Do not shake the solution.

Discard the unused portion remaining in the vials. Storage of Infusion Solution UPLIZNA does not contain a preservative. Administer the prepared infusion solution immediately. If not administered immediately, store the infusion solution for a maximum of 24 hours in the refrigerator between 2°C to 8°C (36°F to 46°F) or 4 hours at room temperature between 20°C to 25°C (68°F to 77°F) prior to the start of the infusion.