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.

IQIRVO (NDA-218860)

(ELAFIBRANOR)

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

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08/07/2026 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myalgia, Myopathy, and Rhabdomyolysis

Additions and/or revisions underlined:

…

Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis. IQIRVO may be restarted if an alternative etiology for these signs and symptoms has been identified and resolved. However, discontinue IQIRVO if signs and symptoms recur.

Patients concomitantly taking peroxisome proliferator-activated receptor-alpha (PPAR-alpha) agonists (e.g., fenofibrate, fenofibric acid) may have an increased risk of muscle injury. Monitor for signs and symptoms of muscle injury during concomitant use with IQIRVO [see Drug Interactions (7.2)].

5.3 Adverse Effects on Fetal and Newborn Development

Additions and/or revisions underlined:

Based on findings from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. Treatment of pregnant rats with elafibranor at maternal plasma drug exposures lower than or approximately equal to human exposure at the recommended dose resulted in stillbirths, reduced survival, decrease in pup body weight, and/or blue/black discoloration of the caudal section of body [see Use in Specific Populations (8.1)].

For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy.

IQIRVO may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol. Advise females of reproductive potential to avoid use of hormonal contraceptives containing ethinyl estradiol and to use alternative contraception, including progestin-only contraceptives containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose of IQIRVO [see Drug Interactions (7.1), Use in Specific Populations (8.3)].

5.4 Drug-Induced Liver Injury

Additions and/or revisions underlined:

…

Patients concomitantly taking PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid) and/or PPAR-gamma agonists (e.g., pioglitazone, rosiglitazone) may have an increased risk of liver injury. Monitor for signs and symptoms of liver injury during concomitant use with IQIRVO [see Drug Interactions (7.2)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Gastrointestinal Adverse reactions

Gastrointestinal symptoms were observed in 35 (32%) IQIRVO-treated patients compared to 6 (11%) in the placebo-treated patients. The severity of gastrointestinal events was mild in 43% of events and was moderate in 51% of events. The median time to onset was 13 (0.3 to 92) weeks for diarrhea, 4 (0.1 to 26) weeks for nausea, and 23 (4 to 55) weeks for vomiting. The median duration of events was 0.6 (0.3 to 86) weeks for diarrhea, 2 (0.1 to 89) weeks for nausea and 0.3 (0.1 to 51) weeks for vomiting without requiring discontinuation of IQIRVO.

…

7 Drug Interactions

7.1 Effects of IQIRVO on Other Drugs

Table 3 includes clinically significant drug interactions affecting other drugs.

Changes to Table 3: Clinically Significant Interactions Affecting Other Drugs; please refer to label for complete information

7.2 Effects of Other Drugs on IQIRVO

Table 4 includes clinically significant drug interactions affecting IQIRVO.

Changes to Table 4: Clinically Significant Interactions Affecting IQIRVO; please refer to label for complete information

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

…

There is a pregnancy safety study for IQIRVO. If IQIRVO is administered during pregnancy, healthcare providers should report IQIRVO exposure by contacting Ipsen Biopharmaceuticals, Inc. at 1-844-990-0239 or www.iqirvopregnancyregistry.com.

…

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

…

Females

Use of IQIRVO may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol. Advise females of reproductive potential to avoid use of hormonal contraceptives containing ethinyl estradiol and to use alternative contraception, including progestin-only contraceptives containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose [see Drug Interactions (7.1)].

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

Before taking IQIRVO, tell your healthcare provider about all of your medical conditions, including if you:

have advanced liver disease.
are pregnant or plan to become pregnant. IQIRVO can harm your unborn baby. You should not become pregnant during treatment with IQIRVO.
- Pregnancy Registry. There is a pregnancy registry for women who become pregnant while taking IQIRVO. If you become pregnant while receiving IQIRVO, tell your healthcare provider right away. Talk to your healthcare provider about providing information to the IQIRVO pregnancy registry. The purpose of this study is to collect information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by calling 1-844-990-0239 or visiting www.iqirvopregnancyregistry.com

…

Females who can become pregnant:

You should use an effective method of birth control, such as progestin-only contraceptives containing levonorgestrel or norgestrel, or intrauterine systems, or effective non hormonal contraceptives while you are taking IQIRVO and for 3 weeks after the last dose of IQIRVO.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IQIRVO can affect the way certain medicines work. Certain medicine may affect the way IQIRVO works.
Especially tell your healthcare provider if you use or take:

a hormonal birth control method such as pills, shots, patches and implants. Hormonal birth control methods may not work as well when taken with IQIRVO.

…

What are the possible side effects of IQIRVO? IQIRVO can cause serious side effects including:

Muscle problems (myalgia, myopathy, rhabdomyolysis). IQIRVO can cause muscle problems that can be severe. Treatment with IQIRVO may cause muscle pain or worsen existing pain and can increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should test for muscle weakness or pain before and during treatment. If there is new onset or worsening of muscle pain, your healthcare provider may temporarily stop your treatment. IQIRVO may be restarted if another cause for your symptoms has been identified and resolved. If your symptoms come back after restarting, your healthcare provider will stop IQIRVO permanently. Call your healthcare provider right away if you have any of the following signs or symptoms:

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Contraception

Advise females of reproductive potential that use of IQIRVO may reduce the efficacy of hormonal contraceptives containing ethinyl estradiol. Advise females of reproductive potential to avoid use of hormonal contraceptives containing ethinyl estradiol and to use alternative contraception, including progestin-only contraceptives containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose [see Drug Interactions (7.1) and Use in Specific Populations (8.3)].

Pregnancy

Inform patients that there is a pregnancy safety study tracking pregnancy exposures and outcomes with IQIRVO. Ask pregnant women to report IQIRVO exposure by contacting Ipsen Biopharmaceuticals, Inc. at 1-844-990-0239 or www.iqirvopregnancyregistry.com.

…