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.

VABOMERE (NDA-209776)

(MEROPENEM; VABORBACTAM)

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

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02/20/2026 (SUPPL-10)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post approval use of meropenem, a component of VABOMERE, or with VABOMERE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Musculoskeletal Disorders: rhabdomyolysis

Hepatobiliary Disorders: drug-induced liver injury (DILI), including hepatitis and liver failure

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Subsection title revised

12/03/2024 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Rhabdomyolysis

Newly added subsection:

Rhabdomyolysis has been reported with the use of meropenem, a component of VABOMERE

[see Adverse Reactions (6.2)]. If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine, or elevated creatine phosphokinase are observed, discontinue VABOMERE and initiate appropriate therapy.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Rhabdomyolysis [see Warnings and Precautions (5.3)]
6.2 Postmarketing Experience
Newly added subsection:
The following adverse reactions have been identified during postapproval use of meropenem, a component of VABOMERE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal Disorders: rhabdomyolysis

09/21/2023 (SUPPL-4)

Approved Drug Label (PDF)

7 Drug Interactions

7.3 Potential for VABOMERE to Affect Other Drugs

Newly added subsection:

When administering VABOMERE concomitantly with medicinal products that are predominantly metabolized by CYP1A2, CYP3A4, CYP2C, and/or are substrates of P-gp transporters, there is a potential risk of interaction which may result in decreased plasma concentrations and activity of the co-administered drug(s) [see Clinical Pharmacology (12.3)].

When VABOMERE is concomitantly administered with the substrates of CYP1A2, CYP3A4, CYP2C, and/or P-gp, refer to the prescribing information for these concomitant medications for guidance on need for dosage adjustments and/or need for frequent drug level monitoring when administered with a weak CYP inducer(s).

When administering VABOMERE concomitantly with medicinal products that are substrate of OAT3 transporters, there is a potential risk of interaction which may result in increased plasma concentrations and activity of the co-administered drug(s) [see Clinical Pharmacology (12.3)]. When VABOMERE is concomitantly administered with OAT3 substrate(s), refer to the prescribing information for these concomitant medication(s) for guidance on need for dosage adjustments and/or need for frequent drug level monitoring when administered with an OAT3 inhibitor(s).

7.4 Hormonal Contraceptives

Newly added subsection:

Hormonal contraceptives (e.g., combined oral contraceptives containing a progestin and an estrogen) are metabolized by CYP3A and other pregnane X receptor (PXR)-regulated enzymes. Therefore, the blood concentration and the effectiveness of hormonal contraceptives may be reduced when used with VABOMERE [see Clinical Pharmacology (12.3)]. Effective alternative non-hormonal forms of contraception or additional contraceptive methods are recommended for patients taking hormonal contraceptives when treated concomitantly with VABOMERE [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.3)]

8 Use in Specific Populations

8.3 Females and Males of Childbearing Potential

Newly added subsection:

Use of VABOMERE may reduce the effectiveness of hormonal contraceptives. Advise patients taking hormonal contraceptives to use an effective alternative non-hormonal contraception or additional contraceptive method (e.g., barrier method of contraception) during treatment with VABOMERE [see Drug Interactions (7.4)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Interaction with Hormonal Contraceptives

Advise patients that administration of VABOMERE may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with VABOMERE [see Drug Interactions (7.4) and Use in Specific Populations (8.3)].

…