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.

RECARBRIO (NDA-212819)

(CILASTATIN SODIUM; IMIPENEM; RELEBACTAM)

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

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12/09/2025 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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Pediatric Patients

Clinical Trial Experience in Pediatric Patients with HABP/VABP, cUTI and cIAI

RECARBRIO was evaluated in an open-label, randomized, active-controlled, multi-dose, phase 2/3 clinical trial (Trial 4) in pediatric patients from birth to less than 18 years of age with HABP/VABP, cUTI or cIAI [see Clinical Studies (14.3)]. A total of 85 patients were treated with RECARBRIO and 28 were treated with a comparator agent (investigator's choice from a specified list of comparators). RECARBRIO was administered intravenously as a weight-based dose of 37.5 mg/kg (imipenem 15 mg/kg, cilastatin 15 mg/kg, and relebactam 7.5 mg/kg) every 6 hours or 8 hours, or a fixed-dose of 1.25 grams (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) every 6 hours. In Trial 4, adverse reactions were comparable to those observed in adults. No patient died in either intervention group in the study through Day 28. The most common adverse reactions occurring in greater than 3% of pediatric patients receiving RECARBRIO were vomiting (15%), diarrhea (9%), nausea (7%), headache (6%), phlebitis/infusion site reactions (including phlebitis, infusion site phlebitis, infusion site extravasation, medical device site dermatitis; 5%), and rash (including rash, rash erythematous, rash maculopapular; 4%).

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of RECARBRIO for the treatment of HABP/VABP, and for the treatment of cUTI and cIAI in patients who have limited or no alternative treatment options have been established in pediatric patients weighing at least 2 kg. Use of RECARBRIO in pediatric patients is supported by evidence from an adequate and well-controlled trial of RECARBRIO in adults with HABP/VABP, controlled trials in adults with cUTI and cIAI, and additional pharmacokinetic, safety, and efficacy data from pediatric trials [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2 and 14.3)].

The safety profile of RECARBRIO in pediatric patients from the pediatric trials was comparable to that in adults treated with RECARBRIO [see Adverse Reactions (6.1)].

RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age) or weighing less than 30 kg with renal impairment.

The safety and effectiveness of RECARBRIO for the treatment of HABP/VABP, cUTI or cIAI have not been established in pediatric patients weighing less than 2 kg.

8.6 Renal Impairment

Additions and/or revisions underlined:

Reduce RECARBRIO dosage in adult patients with a CLcr less than 90 mL/min and in pediatric patients weighing at least 30 kg with an eGFR less than 90 mL/min/1.73 m2 [see Dosage and Administration (2.3, 2.4) and Clinical Pharmacology (12.3)]. RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment.

06/04/2020 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions, please refer to label for complete information)

8 Use in Specific Populations

8.5 Geriatric Use

(Additions and revisions underlined)

Of the 266 patients treated with RECARBRIO in Trial 1, 113 (42.5 %) were 65 years of age or older, including 55 (20.7 %) patients 75 years of age and older. Of the 216 patients treated with imipenem/cilastatin plus relebactam 250 mg in Trials 2 and 3, 67 (31.0 %) were 65 years of age or older, including 25 (11.6 %) patients 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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