Administration Information

Preparing and administering UPLIZNA

Watch to learn key steps when preparing an UPLIZNA infusion for your patient

Chapter 1

NMOSD and UPLIZNA

Chapter 2

Preparation and Premedication

Chapter 3

Dilution

Chapter 4

Infusion

Chapter 5

Resources and Support

Dosage¹

UPLIZNA is administered as an IV infusion. The recommended dosage is:

Initial dose: 300-mg IV infusion followed 2 weeks later by a second 300-mg IV infusion
Subsequent doses (starting 6 months from the first infusion): single 300-mg IV infusion every 6 months

Screening¹

Check IgG levels and test for hepatitis B virus and tuberculosis prior to treatment administration
Administer all recommended vaccinations at least 4 weeks prior to initiation of UPLIZNA

Preparation¹

Visually inspect UPLIZNA solution for particulate matter and discoloration. If the solution is cloudy, discolored, or contains discrete particulate matter, do not use and contact the manufacturer
(1-866-479-6742). Do not shake the vial.

Obtain an IV 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 IV bag
Mix diluted solution by gentle inversion. Do not shake the solution
Discard the unused portion remaining in the vials

Premedication

A corticosteroid, an antihistamine, and an antipyretic are given 30 to 60 minutes prior to administration to reduce infusion reactions^1,2
Monitor the patient closely for infusion reactions during and for at least 1 hour after the completion of the infusion¹

Premedication: administer approximately 30 to 60 minutes prior to each UPLIZNA infusion^1,2

Type of premedication	Route of administration	Examples of (or equivalent)	Administration time prior to UPLIZNA infusion
Corticosteroid	IV	Methylprednisolone 80 mg to 125 mg	30 minutes
Antihistamine	Oral	Diphenhydramine 25 mg to 50 mg	30 to 60 minutes
Antipyretic	Oral	Acetaminophen 500 mg to 650 mg	30 to 60 minutes
Type of premedication	Corticosteroid	Antihistamine	Antipyretic
Route of administration	IV	Oral	Oral
Examples of (or equivalent)	Methylprednisolone 80 mg to 125 mg	Diphenhydramine 25 mg to 50 mg	Acetaminophen 500 mg to 650 mg
Administration time prior to UPLIZNA infusion	30 minutes	30 to 60 minutes	30 to 60 minutes

Administration¹

Administer UPLIZNA under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage potential severe reactions.

Administer the prepared solution intravenously via an infusion pump at an increasing rate to completion, approximately
90 minutes, according to the schedule below. Administer through an IV line containing a sterile, low-protein binding 0.2
or 0.22 micron in-line filter.

Recommended infusion rate for UPLIZNA administration when diluted in a 250-mL IV bag¹

Infusion Rate (mL/hour)	Elapsed Time (minutes)
42	0 to 30
125	31 to 60
333	61 to completion
Infusion Rate (mL/hour)	42	125	333
Elapsed Time (minutes)	0 to 30	31 to 60	61 to completion

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

A history of life-threatening infusion reaction to UPLIZNA

Active hepatitis B infection

Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.