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.

ETICOVO (BLA-761066)

(ETANERCEPT-YKRO)

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

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12/05/2025 (SUPPL-6)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

…

Reports of etanercept use during the third trimester of pregnancy demonstrated that placental transfer of etanercept was low in infants at birth (see Data). There are risks to the mother and fetus associated with active rheumatoid arthritis. The theoretical risks of administration of live or live-attenuated vaccines to the infants exposed in utero to Eticovo should be weighed against the benefits of vaccinations (see Clinical Considerations).

…

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis is correlated with maternal disease activity and that active disease increases the risk of adverse pregnancy outcomes, including fetal loss, preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) and small for gestational age birth.

…

Data

Human Data

…

Reports from the literature showed that cord blood levels of etanercept at delivery, in infants born to women administered etanercept during pregnancy, varied from undetectable to 32% of the maternal serum level. In a cohort study of 30 pregnant women with RA, 29 were treated with etanercept until 30 weeks of gestation and 1 was treated until 36 weeks of gestation. Etanercept was not detected in the cord blood sample from any infant at delivery. In three published case reports, etanercept was detected in cord blood at levels of 3.3, 3.6, and 7.4% of the maternal concentration, when etanercept was administered at 50 mg every 7-12 days in pregnancy until 4 days prior to delivery, 25 mg twice weekly until 36 weeks of gestation, and 25 mg subcutaneous every week through the third trimester, respectively. There was one post-marketing safety report of a pregnant woman who received etanercept 25 mg once to twice weekly throughout pregnancy, and etanercept was detected in cord blood at 32% of the maternal concentration.

…

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Data from published literature show that etanercept is present in low levels in human milk but is not detected in the plasma of breastfed infants (see Data). There are no data on the effects of etanercept products on milk production. There have been no consistent reports of adverse events in breastfed infants over decades of use. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Eticovo and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Data

In three case reports, etanercept was detected in breast milk at levels ranging from <2 to 7.5 ng/mL after lactating women had received doses of etanercept of 25 mg weekly or twice weekly. Although etanercept was detected in breast milk in these cases, etanercept was not detected in the serum of the breastfed infants

05/03/2024 (SUPPL-1)

Approved Drug Label (PDF)

4 Contraindications

Additions and revisions underlined:

Eticovo is contraindicated in patients with sepsis.

5 Warnings and Precautions

5.4 New Onset or Worsening of Heart Failure

Subsection title revised

5.11 Not Recommended for Use in Patients with Granulomatosis with Polyangiitis Receiving Immunosuppressants

Subsection title revised

Additions and revisions underlined:

The use of Eticovo in patients with granulomatosis with polyangiitis receiving immunosuppressive agents is not recommended. In a study of patients with granulomatosis with polyangiitis, the addition of etanercept to standard therapy (including cyclophosphamide) was associated with a higher incidence of non-cutaneous solid malignancies and was not associated with improved clinical outcomes when compared with standard therapy alone [see Drug Interactions (7.3)].

5.12 Not Recommended for Use with Anakinra or Abatacept

Subsection title revised

5.13 Increased Mortality in Patients with Moderate to Severe Alcoholic Hepatitis

Subsection title revised

6 Adverse Reactions

6.2 Immunogenicity

Additions and revisions underlined:

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of etanercept or of other etanercept products.

8 Use in Specific Populations

8.4 Pediatric Use

Newly added information:

Polyarticular Juvenile Idiopathic Arthritis

The safety and effectiveness of Eticovo have been established in pediatric patients 2 years of age and older with pJIA. Etanercept has been studied in 69 children with moderately to severely active polyarticular JIA 2 to 17 years of age.

The safety and effectiveness of Eticovo in pediatric patients less than 2 years of age with pJIA have not been established.

Plaque Psoriasis

The safety and effectiveness of Eticovo for plaque psoriasis have been established in pediatric patients 4 years of age and older. Etanercept has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years.

The safety and effectiveness of Eticovo in pediatric patients below the age of 4 years with PsO have not been established.

Malignancies in Pediatric Patients

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at less than or equal to 18 years of age), including etanercept products [see Warnings and Precautions (5.3)].

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

When using the single-dose prefilled Auto Injector pen to administer Eticovo, the patient or caregiver should be informed that the window turns yellow when the injection is complete. After removing the prefilled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means the patient has not received a full dose. The patient or caregiver should be advised to call their healthcare provider immediately.

A puncture-resistant container for disposal of needles, and syringes, Auto Injector pens should be used.

Medication Guide

. . .

Eticovo is used to treat:

. . .

psoriatic arthritis (PsA) in adults. Eticovo can be used alone or with methotrexate.

. . .

Eticovo is available in the forms listed below. Your healthcare provider will prescribe the type that is best for you.

Single-dose Prefilled Syringe
Single-dose Prefilled Auto Injector Pen