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.

KERENDIA (NDA-215341)

(FINERENONE)

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

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07/11/2025 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Worsening of Renal Function in Patients with Heart Failure

Newly added subsection:

Kerendia can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed [see Adverse Reactions (6.1)].

Measure eGFR in all patients before initiation of treatment or with dose titration of Kerendia and dose accordingly [see Dosage and Administration (2.1, 2.3)]. Initiation of Kerendia in patients with heart failure and an eGFR <25 mL/min/1.73m2 is not recommended.

Measure eGFR periodically during maintenance treatment with Kerendia in patients with heart failure. Consider delaying up-titration or interrupting treatment with Kerendia in patients who develop clinically significant worsening of renal function.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .
CKD associated with T2DM

The safety of Kerendia in patients with CKD associated with T2DM was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively.

. . .

Heart Failure with LVEF greater than or equal to 40%

The safety of Kerendia in patients with heart failure (LVEF greater than or equal to 40%) was evaluated in the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 study, FINEARTS-HF, in which a total of 2,993 patients were treated with 10 mg, 20 mg, or 40 mg once daily of Kerendia with a mean duration of treatment of 2.3 years.

The overall safety profile of Kerendia in the FINEARTS-HF study was largely consistent with the adverse reactions reported in patients with CKD and T2DM (Table 4). However, adverse reactions related to worsening renal function were reported more frequently in the Kerendia group (18%) compared with placebo (12%) in FINEARTS-HF. The most frequently reported adverse reactions included renal impairment (7% vs. 4%), eGFR decreased (5% vs. 4%), acute kidney injury (4% vs. 2%) and renal failure (3% vs. 2%). The majority of events were reported to be mild to moderate. These events led to dose modifications in 9% of patients receiving Kerendia versus 4% of patients receiving placebo.

Hospitalization due to events related to worsening of renal function for the Kerendia group was 2.0% versus 1.3% in the

placebo group.

Laboratory Test

Initiation of Kerendia may cause an initial small increase in blood creatinine levels (mean change less than 0.1 mg/dL) and a small decrease in eGFR (mean change 2-3 ml/min) that occurs within the first 4 weeks of starting therapy and then stabilizes. These changes were reversible after treatment discontinuation. Initiation of Kerendia may also cause a small increase in serum uric acid. This increase appears to attenuate over time.

6.2 Postmarketing Experience

Newly added subsection

The following additional adverse reactions have been reported in postmarketing experience with finerenone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure:

Hypersensitivity: Angioedema, Rash and Urticaria

7 Drug Interactions

7.1 Effect of Other Drugs on Kerendia

Subsection title revised

7.2 Effect of Kerendia on Other Drugs

Newly added subsection

CYP2C8 Substrates

Kerendia is a weak CYP2C8 inhibitor at 40 mg. Kerendia increases exposure of CYP2C8 substrates at 40 mg dose [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions related to these substrates. Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if Kerendia 40 mg is co- administered with such substrates since minimal concentration changes may lead to serious adverse reactions.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

. . .

Data

Animal Data

In the embryo-fetal toxicity study in rats, finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day corresponding to an AUCunbound of at least 7 times that in humans. At 30 mg/kg/day, the incidence of visceral and skeletal variations was increased (slight edema, shortened umbilical cord, slightly enlarged fontanelle) and one fetus showed complex malformations including a rare malformation (double aortic arch) at an AUCunbound of about 10 times that in humans at the 40 mg dose and about 25 times that in humans at the 20 mg dose. The doses free of any findings (low dose in rats, high dose in rabbits) provide safety margins of 4 to 5 times for the AUCunbound expected in humans.

When rats were exposed during pregnancy and lactation in the pre- and postnatal developmental toxicity study, increased pup mortality and other adverse effects (lower pup weight, delayed pinna unfolding) were observed at about 2 or 4 times the AUCunbound expected in humans at the dose of 40 mg and 20 mg, respectively. In addition, the offspring showed slightly increased locomotor activity, but no other neurobehavioral changes starting at about 2 or 4 times the AUCunbound expected in humans at the dose of 40 mg and 20 mg, respectively. The dose free of findings provides a safety margin of about 2 times for the AUCunbound expected in humans for the 20 mg dose and is in the therapeutic range for the 40 mg dose.

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the 6510 patients who received Kerendia in the FIDELIO-DKD and FIGARO-DKD studies, 55% of patients were 65 years and older, and 14% were 75 years and older. Of the 2993 patients who received Kerendia in the FINEARTS study, 79% of patients were 65 years and older, and 43% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.