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.

TYENNE (BLA-761449)

(TOCILIZUMAB-AAZG)

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

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05/21/2026 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.10 Clinical Trials Experience in COVID-19 Patients Treated with Intravenous Tocilizumab (tocilizumab-IV)

Additions and/or revisions underlined:

The safety of tocilizumab in hospitalized adult COVID-19 patients was evaluated in a pooled safety population that includes patients enrolled in EMPACTA, COVACTA, AND REMDACTA. The analysis of adverse reactions included a total of 974 patients exposed to tocilizumab. Patients received a single, 60-minute infusion of intravenous tocilizumab 8 mg/kg (maximum dose of 800 mg). If clinical signs or symptoms worsened or did not improve, one additional dose of tocilizumab 8 mg/kg could be administered between 8- 24 hours after the initial dose.

Adverse reactions summarized in Table 3 occurred in at least 3% of tocilizumab-treated patients and more commonly than in patients on placebo in the pooled safety population.

Table 3 Adverse Reactions Identified From the Pooled COVID-19 Adult Safety Population

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Laboratory Abnormalities

In the pooled adult safety population of EMPACTA, COVACTA, and REMDACTA, neutrophil counts <1000 cells/mcl occurred in 3.4% of patients who received tocilizumab and 0.5% of patients who received placebo. Platelet counts <50,000 cells/mcl occurred in 3.2% of patients who received tocilizumab and 1.5% of patients who received placebo. ALT or AST at or above 5x ULN occurred in 11.7% of patients who received tocilizumab and 9.9% of patients who received placebo.

6.11 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of tocilizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity Reactions: Fatal anaphylaxis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)]
Pancreatitis
Drug-induced liver injury, Hepatitis, Hepatic failure, Jaundice [see Warnings and Precautions (5.3)]
Hypofibrinogenemia

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

TYENNE by intravenous use is indicated for the treatment of pediatric patients with:

Active systemic juvenile idiopathic arthritis in patients 2 years of age and older
Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Severe or life-threatening CAR T cell-induced cytokine release syndrome (CRS) in patients 2 years of age and older.
Hospitalized Coronavirus disease 2019 (COVID-19) patients 2 years of age and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

TYENNE by subcutaneous use is indicated for the treatment of pediatric patients with:

Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Active systemic juvenile idiopathic arthritis in patients 2 years of age and older

The safety and effectiveness of TYENNE in pediatric patients with conditions other than PJIA, SJIA, CRS or COVID-19 have not been established. The safety and effectiveness in pediatric patients below the age of 2 have not been established in PJIA, SJIA, CRS or COVID-19.

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Systemic Juvenile Idiopathic Arthritis – Intravenous Use

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The safety and immunogenicity of tocilizumab for patients with SJIA under 2 years of age was assessed descriptively. SAEs, AEs leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Six patients (54.5%) experienced hypersensitivity reactions, defined as all adverse events occurring during or within 24 hours after an infusion considered related to tocilizumab. Three of these patients experienced serious hypersensitivity reactions and were withdrawn from the study. Three patients with hypersensitivity reactions (two with serious hypersensitivity reactions) developed treatment induced anti-tocilizumab antibodies after the event. There were no cases of MAS based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria1.

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COVID-19 – Intravenous Use

The safety and effectiveness of TYENNE have been established for the treatment of pediatric patients aged 2 years and older with COVID-19. Use of TYENNE in these age groups is supported by evidence from adequate and well-controlled studies of tocilizumab in adults with COVID-19 [See Adverse Reactions (6.10) and Clinical Studies (14.10)], predicted pharmacokinetic data modeling and simulation for pediatric patients aged 2 years and older with COVID-19 [See Clinical Pharmacology (12.3)], safety data from a randomized, double-blind, placebo-controlled study of tocilizumab in pediatric patients aged 2 years and older with systemic juvenile idiopathic arthritis, and additional uncontrolled pharmacovigilance data in pediatric patients aged 2 years and older with COVID-19 who received tocilizumab under Emergency Use Authorization.

The safety and effectiveness of TYENNE has not been established in pediatric COVID-19 patients younger than 2 years of age

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

MEDICATION GUIDE

Additions and/or revisions underlined:

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What is TYENNE?

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To treat hospitalized people ages 2 years and above with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.
TYENNE is not approved for subcutaneous use in people with CRS or COVID-19.

It is not known if TYENNE is safe and effective in children with PJIA, SJIA, CRS or COVID-19 under 2 years of age or in children with conditions other than PJIA, SJIA, CRS or COVID-19.

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