Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

UPLIZNA (BLA-761142)

(INEBILIZUMAB-CDON)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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12/11/2025 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infusion Reactions

Additions and/or revisions underlined:

UPLIZNA can cause infusion reactions, including anaphylaxis. Symptoms of infusion reactions can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations.

Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.

…

5.2 Infections

Additions and/or revisions underlined:

Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA

The most common infections reported by UPLIZNA-treated patients in the randomized and open-label clinical trial periods for NMOSD included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In theIgG4-RD randomized controlled and open-label periods, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). In the gMG randomized controlled period, the most common infections reported by UPLIZNA-treated patients were urinary tract infection (7%) and nasopharyngitis (7%).

Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants

If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.

Hepatitis B Virus (HBV) Reactivation

HBV reactivation has been observed with the use of B-cell depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies.

HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial, and has also been observed in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials.

Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer UPLIZNA to patients with active HBV infection confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment with UPLIZNA.

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

Additions and/or revisions underlined:

NMOSD

Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (aged 18 to 64 years of age).

IgG4-RD

Twenty-nine percent (32 out of 112) of patients 65 years of age or older, were treated with UPLIZNA. There were no overall age-related differences in safety or efficacy observed compared to younger patients (aged 18 to 64 years of age).

gMG

Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients (aged 18 to 64 years of age).

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

…

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with:
- Neuromyelitis optic spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
- Immunoglobulin G4-related disease (IgG4-RD).
- Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.

It is not known if UPLIZNA is safe or effective in children.

…

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

have or think you have an infection.
have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD, IgG4-RD, or gMG. These medicines may increase your risk of getting an infection.

…

What are the possible side effects of UPLIZNA? UPLIZNA may cause serious side effects, including:

See “What is the most important information I should know about UPLIZNA?”
low blood cell counts. UPLIZNA may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.
The most common side effects in patients with NMOSD include urinary tract infection and joint pain.
The most common side effects in patients with IgG4-RD include urinary tract infection and low white blood cell count. The most common side effects in patients with gMG include headache and infusion-related reactions.
These are not all the possible side effects of UPLIZNA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

…

04/03/2025 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infusion Reactions

Additions and/or revisions underlined:

UPLIZNA can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period, infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the randomized controlled period. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.

…

5.2 Infections

Additions and/or revisions underlined:

An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the randomized and open-label clinical trial periods for NMOSD included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD randomized controlled and open-label periods, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

IgG4-RD

The safety of UPLIZNA was evaluated in Study 2, in which 68 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 67 patients received placebo [see Dosage and Administration (2.1) and Clinical Studies (14)].

Table 4 lists adverse reactions that occurred in at least 5% of patients treated with UPLIZNA and at a greater incidence than in patients who received placebo in Study 2. The most common adverse reactions (incidence of at least 10% in patients treated with UPLIZNA and at a greater incidence than placebo) were urinary tract infection and lymphopenia.

Please refer to label to view Table 4.

Additional adverse reactions during the randomized controlled period in Study 2 were infusion related reactions, influenza, and pneumonia.

Laboratory Abnormalities

Decreased Immunoglobulins

…

IgG4-RD

At the end of the 12-month randomized, controlled period, relative to baseline, the total immunoglobulin level was reduced approximately 12% from baseline for patients treated with UPLIZNA as compared to an increase of 21% in patients treated with placebo. The mean decreases from baseline in immunoglobulin G (IgG) and immunoglobulin M (IgM) were approximately 9% and 32%, respectively, in patients treated with UPLIZNA, whereas IgG was increased by 26% and IgM was increased by approximately 3% in placebo-treated patients.

Decreased Neutrophil Counts

…

IgG4-RD

During the 12-month randomized, controlled period, neutrophil counts between 1.0-1.5 × 109/L were observed in 7.5% of UPLIZNA-treated patients versus 3% of patients who received placebo. Neutrophil counts between 0.5-1.0 × 109/L were observed in 1.5% of patients treated with placebo compared to no patients who received UPLIZNA.

Decreased Lymphocyte Counts

IgG4-RD

A reduction in lymphocyte counts was observed more frequently in patients treated with UPLIZNA compared to those who received placebo. During the 12-month randomized, controlled period, the proportion of patients with a lymphocyte count below the limit of normal was 41.8% for patients treated with UPLIZNA compared to 35.8% for patients who received placebo.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to UPLIZNA during pregnancy or shortly before conception. Healthcare providers are encouraged to advise their patients to register by contacting the UPLIZNA Pregnancy Registry by calling the coordinating center at 1 (303) 724-4644 or www.upliznapregnancyregistry.com.

…

8.5 Geriatric Use

Additions and/or revisions underlined:

…

IgG4-RD

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Infusion Reactions

Inform patients about the signs and symptoms of infusion reactions, including anaphylaxis, and advise them to contact their healthcare provider immediately if they observe signs or symptoms of infusion reactions [see Warnings and Precautions (5.1)].

…

Pregnancy

Instruct patients that if they are pregnant or plan to become pregnant while taking UPLIZNA, they should inform their healthcare provider [see Use in Specific Populations (8.1)]. Advise females of reproductive potential that they should use effective contraception during treatment and for 6 months after UPLIZNA therapy [see Use in Specific Populations (8.3)]. Advise patients to register with the UPLIZNA pregnancy exposure registry [see Use in Specific Populations (8.3)].

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about UPLIZNA? UPLIZNA may cause serious side effects, including:

Infusion reactions. UPLIZNA can cause infusion reactions, including anaphylaxis, that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:

Headache
Sleepiness
Fever
Rash
Nausea
shortness of breath
muscle aches
palpitations

…

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with:
- Neuromyelitis optic spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
- Immunoglobulin G4-related disease (IgG4-RD).
  …
  Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

have or think you have an infection.
have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD and IgG4-RD. These medicines may increase your risk of getting an infection.
…
Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to UPLIZNA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking UPLIZNA, you are encouraged to enroll in the pregnancy registry by calling 1-303-724-4644 or by visiting online at www.upliznapregnancyregistry.com. are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive UPLIZNA.
…
What are the possible side effects of UPLIZNA?
UPLIZNA may cause serious side effects, including:
…
The most common side effects include urinary tract infection and joint pain in patients with NMOSD.
The most common side effects include urinary tract infection and low white blood cell count in patients with IgG4-RD. These are not all the possible side effects of UPLIZNA.
…