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.

YESINTEK (BLA-761406)

(USTEKINUMAB-KFCE)

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

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08/14/2026 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

YESINTEK is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in YESINTEK [see Warnings and Precautions (5.5)].

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

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Crohn’s disease in adults: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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Malignancies other than non-melanoma skin cancer in ustekinumab-treated subjects during the controlled and uncontrolled portions of trials were similar in type and number to what would be expected in the general U.S. population according to the 1969-2004 SEER database (adjusted for age, gender and race).1

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Adult Subjects with Crohn’s Disease

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What is YESINTEK?

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It is not known if YESINTEK is safe and effective in children less than 18 years of age with ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.

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Who should not use YESINTEK?

Do not use YESINTEK if you are allergic to any ustekinumab product or any of the ingredients in YESINTEK.

How should I use YESINTEK?

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The needle cap on the YESINTEK prefilled syringe is not made with natural rubber latex.

The prefilled autoinjector is not made with natural rubber latex.

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Injecting YESINTEK under the skin

YESINTEK is intended for use under the guidance and supervision of a healthcare provider.
In children, it is recommended that YESINTEK be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of YESINTEK at home, you or caregiver should receive training on the right way to prepare and give the injections.
Do not try to inject YESINTEK until you have been shown how to give the injections by a healthcare provider.

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How should I store YESINTEK?

Store YESINTEK vials, prefilled syringes, and prefilled autoinjectors in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store YESINTEK vials standing up straight (upright).
Store YESINTEK in the original carton to protect it from light until time to use it.
Do not freeze YESINTEK.
Do not shake YESINTEK.
If needed, individual YESINTEK prefilled syringes and prefilled autoinjectors may also be stored at room temperature up to 86ºF (30°C) for a maximum single period of up to 30 days in the original carton to protect from light.
Record the date when the prefilled syringe and prefilled autoinjectors are first removed from the refrigerator on the carton in the space provided.
After a prefilled syringe and prefilled autoinjectors have been stored at room temperature, do not return it to the refrigerator.
Throw away (discard) the prefilled syringe and prefilled autoinjectors if it is not used within 30 days at room temperature storage.

Do not use YESINTEK after the expiration date on the carton or on the prefilled syringe and prefilled autoinjectors.

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What are the ingredients in YESINTEK?

Active ingredient: ustekinumab-kfce

Inactive ingredients: Single-dose prefilled syringe, single-dose prefilled autoinjector, and single-dose vial for subcutaneous use …

01/07/2026 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

Additions and/or revisions underlined:

5.5 Serious Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of ustekinumab products [see Adverse Reactions (6.1, 6.3)].

If a severe or clinically significant hypersensitivity reaction occurs, discontinue YESINTEK immediately and initiate appropriate medical treatment [see Contraindications (4)].

6 Adverse Reactions

Additions and/or revisions underlined:

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Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5)]

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6.3 Postmarketing Experience

Additions and/or revisions underlined:

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Immune system disorders: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, dyspnea, rash, urticaria), including a fatal case that presented with chest tightness and dyspnea during infusion of the first dose.

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8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data). There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-associated Maternal and Embryo/Fetal Risk

Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Neonatal Adverse Reactions

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ustekinumab products may be present in infants exposed in utero. The potential clinical impact of ustekinumab product exposure in infants exposed in utero should be considered.

Data

Human Data

An observational pregnancy registry conducted by (OTIS)/MotherToBaby in the U.S. and Canada (enrollment between 2013 and 2019) assessed the risk of major birth defects, pattern of major and minor anomalies in live-born infants, miscarriage, and adverse infant outcomes in women with ustekinumab exposure. In the registry study, there were 101 participants and 107 pregnancies with exposure to ustekinumab (88 prospective; 19 retrospective). Most participants had a primary indication of CD (65.4%) or psoriasis (30.8%). The pregnancy registry did not identify a ustekinumab -associated risk of major birth defects, pattern of major or minor anomalies, increased risk of miscarriage or adverse infant outcomes. Methodological limitations of the registry include small sample size, lack of an internal comparison group, a mix of prospective and retrospective reports, and unmeasured confounders. The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance.

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8.4 Pediatric Use

Additions and/or revisions underlined:

Plaque Psoriasis

The safety and effectiveness of YESINTEK have been established for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy.

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Psoriatic Arthritis

The safety and effectiveness of YESINTEK have been established for treatment of psoriatic arthritis in pediatric patients 6 years of age and older.

Use of YESINTEK in these age groups is supported by evidence from adequate and well controlled trials of ustekinumab in adult subjects with psoriasis and PsA, pharmacokinetic data from adult

subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and safety data of ustekinumab from two clinical trials in 44 pediatric subjects 6 to 11 years old with psoriasis and 110 pediatric subjects 12 years of age and older with psoriasis. The observed pre-dose (trough) concentrations are generally comparable between adult subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and the PK exposure is expected to be comparable between adult and pediatric subjects with PsA [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2, 14.3)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Serious Hypersensitivity and Reactions

Inform patients that serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Instruct patients to discontinue YESINTEK and seek immediate medical attention if they experience any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5)].

MEDICATION GUIDE

Additions and/or revisions underlined:

…

How should I use YESINTEK?

Use YESINTEK exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of YESINTEK, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow up appointments.
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What are the possible side effects of YESINTEK?YESINTEK may cause serious side effects, including:

See “What is the most important information I should know about YESINTEK?”
Serious allergic reactions. Serious allergic reactions including death can occur with YESINTEK. Stop using YESINTEK and get medical help right away if you get any of the following symptoms of a serious allergic reaction:
- feeling faint
- o trouble breathing
- swelling of your face, eyelids, tongue, or throat
- o skin rash
- chest discomfort
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  The most common side effects of YESINTEK include:
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influenza
joint pain

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