UPLIZNA Solution for injection Ref.[10302] Active ingredients: Inebilizumab

2.1 Assessments P rior to F irst D ose of UPLIZNA

Hepatitis B Virus Screening

Prior to initiating UPLIZNA, perform Hepatitis B virus (HBV) screening. UPLIZNA is contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with UPLIZNA [see Contraindications (4) and Warnings and Precautions (5.2)].

Serum Immunoglobulins

Prior to initiating UPLIZNA, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with UPLIZNA [see Warnings and Precautions (5.3)].

Tuberculosis Screening

Prior to initiating UPLIZNA, evaluate for active tuberculosis and test for latent infection. For patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating treatment with UPLIZNA [see Contraindications (4) and Warnings and Precautions (5.2)].

Vaccinations

Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA for live or live-attenuated vaccines [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].

2.2 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 (5.2)].

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 (5.2)].

Table 1. Premedication Prior to Each UPLIZNA Infusion:

2.3 Recommended Dosage and Administration

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 (2.4)].

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 (5.1)].

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.

Table 2 Recommended Infusion Rate for UPLIZNA Administration When Diluted in a 250 mL Intravenous Bag:

Monitor the patient closely for infusion reactions during and for at least one hour after the completion of the infusion.

2.4 Preparation and Storage of Infusion Solution

Preparation

Visually inspect UPLIZNA solution for particulate matter and discoloration [see Dosage Forms and Strengths (3)]. If the solution is cloudy, discolored, or it contains discrete particulate matter, do not use and contact the manufacturer (productsafety@vielabio.com). 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.

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Do not shake.
• Store vials upright.