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.

INLURIYO (NDA-218881)

(IMLUNESTRANT TOSYLATE)

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

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09/18/2026 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Refer to the Prescribing Information of abemaciclib when administered in combination with INLURIYO for pregnancy information.

Based on findings in animals and its mechanism of action, INLURIYO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available human data on INLURIYO use in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of imlunestrant to pregnant rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures below the human exposure at the recommended dose based on AUC (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

…

8.2 Lactation

Additions and/or revisions underlined:

Refer to the Prescribing Information of abemaciclib when administered in combination with INLURIYO for lactation information. When used in combination, advise patients to not breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of the individual products.

Risk Summary

There are no data on the presence of imlunestrant or its metabolites in human milk, its effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with INLURIYO and for 1 week after the last dose.

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Refer to the Prescribing Information of abemaciclib when administered in combination with INLURIYO for contraception and infertility information. When used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of the individual products.

INLURIYO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify the pregnancy status in females of reproductive potential prior to initiating INLURIYO.

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8.6 Geriatric Use

Additions and/or revisions underlined:

Of 327 patients who received INLURIYO monotherapy in the EMBER-3 study, 118 patients were greater than or equal to 65 years of age and 37 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness of INLURIYO monotherapy have been observed between patients 65 years of age and older and younger adult patients.

Of the 208 patients who received INLURIYO in combination with abemaciclib in the EMBER-3 study, 90 patients were greater than or equal to 65 years of age and 27 patients were greater than or equal to 75 years of age. There was a higher rate of nausea in patients aged 65 years or older (59%) compared with younger patients (44%). The EMBER-3 study did not include sufficient numbers of patients 65 years of age and older with ESR1 mutations treated with INLURIYO in combination with abemaciclib to determine whether they respond differently than younger patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with INLURIYO and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with INLURIYO and for 1 week after the last dose [see Use in Specific Populations (8.3)].

Refer to the Prescribing Information of abemaciclib when administered in combination with INLURIYO for pregnancy and contraception information. When used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of the individual products.

Lactation

Advise women not to breastfeed during treatment with INLURIYO and for 1 week after the last dose [see Use in Specific Populations (8.2)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

What is INLURIYO?

INLURIYO is a prescription medicine that is used alone or in combination with the medicine abemaciclib to treat adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least 1 line of endocrine therapy.

Your healthcare provider will perform a test to make sure that INLURIYO is right for you.

When INLURIYO is used in combination with abemaciclib, read the Patient Information for abemaciclib. It is not known if INLURIYO is safe and effective in children.

…

Females who are able to become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with INLURIYO.
Use effective birth control (contraception) during treatment with INLURIYO and for 1 week after the last dose.
Your healthcare provider will tell you how long you should use birth control (contraception) after combination treatment with INLURIYO and abemaciclib.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with INLURIYO.

…

Males with female partners who are able to become pregnant:

Use effective birth control (contraception) during treatment with INLURIYO and for 1 week after the last dose.

are breastfeeding or plan to breastfeed. It is not known if INLURIYO passes into breastmilk.
- Do not breastfeed during treatment with INLURIYO and for 1 week after the last dose.
- Your healthcare provider will tell you how long you should not breastfeed after combination treatment with INLURIYO and abemaciclib.

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What are the possible side effects of INLURIYO?

The most common side effects of INLURIYO when taken alone include:

…

The most common side effects of INLURIYO when taken with abemaciclib include:

decreased white blood cell counts
increased liver function tests
diarrhea
increased creatinine blood levels
decreased hemoglobin (anemia)
vomiting
nausea
muscle and joint pain
decreased platelet counts
stomach-area (abdominal) pain
tiredness
decreased appetite
increased triglycerides and cholesterol blood levels. Your healthcare provider will check your blood levels before and during treatment with INLURIYO.
rash
cough
headache
infections
weight loss

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