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.

FUROSCIX (NDA-209988)

(FUROSEMIDE)

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

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12/22/2025 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Incomplete Dosing

Additions and/or revisions underlined:

. . .

The On-body Infusor for FUROSCIX should only be administered in settings where alarms can be detected and responded to in order to ensure a complete dose is administered [see Dosage and Administration (2.2)].

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

FUROSCIX is approved for the treatment of edema in pediatric patients weighing at least 43 kg with chronic heart failure or chronic kidney disease, including the nephrotic syndrome. FUROSCIX has not been studied in pediatric patients. Use of FUROSCIX for this indication is supported by: 1) efficacy, safety, and pharmacokinetic data of furosemide in adult and pediatric patients; 2) pharmacokinetic and pharmacodynamic data of FUROSCIX in adults with New York Heart Association (NYHA) Functional Classification Class II and Class III heart failure [see Clinical Pharmacology (12.2, 12.3)]; and 3) population pharmacokinetic modeling which demonstrated no significant difference in furosemide exposure following FUROSCIX administration in a simulated pediatric population weighing 43 kg and above and aged 6 to <17 years compared to adult patients with chronic heart failure [see Clinical Pharmacology (12.3)].

FUROSCIX is not approved for the treatment of edema in pediatric patients weighing less than 43 kg.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient and/or caregiver to read the FDA-approved patient labeling [see FDA-approved Instructions for Use].

Advise the patient that they should not allow the On-body Infusor to come into contact with water or other fluids. Advise patients and/or caregiver to check the device for alarms to ensure a complete dose is administered [see Warnings and Precautions (5.5)].

. . .

03/06/2025 (SUPPL-3)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Renal Impairment

Newly added subsection:

Significantly reduced renal function can affect the response to furosemide. The On-body Infusor will deliver only an 80 mg dose of furosemide, and patients with significantly reduced renal function may require additional diuretic therapy.

8.7 Hepatic Impairment

Newly added subsection:

In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treat such patients in a setting where clinical status and electrolyte balance can be carefully monitored.

08/09/2024 (SUPPL-1)

Approved Drug Label (PDF)

4 Contraindications

Additions and revisions underlined:

FUROSCIX is contraindicated in patients with anuria.
FUROSCIX is contraindicated in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.

5 Warnings and Precautions

5.5 Incomplete Dosing

Newly added subsection:

The On-body Infusor should not be allowed to get wet from water or any other fluids (blood or drug product). Fluid contact with the circuit board can lead to device errors and premature termination of infusion.

The On-body Infusor is intended for use in a setting where the patient can limit their activity for the duration of administration. Certain patient movements may cause interruption of device adherence to skin and premature termination of infusion.

The On-body Infusor for FUROSCIX should only be used in patients who can detect and respond to alarms to ensure a complete dose is administered.

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

PATIENT COUNSELING INFORMATION

Newly added information:

Advise the patient that they should not allow the On-body Infusor to come into contact with water or other fluids. Patients should check the device for alarms to ensure a complete dose is administered [see Warnings and Precautions (5.5)].