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.

VOQUEZNA (NDA-215151)

(VONOPRAZAN FUMARATE)

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

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11/06/2025 (SUPPL-9)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers are encouraged to register patients by calling 1- 866-609-1612 or visiting https://voqueznapregnancyregistry.com/.

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8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Data from a clinical lactation study indicate that vonoprazan is present in human breast milk in amounts less than 0.03% of the administered maternal dose. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was less than 0.3% of the maternal weight-adjusted dose (see Data). There are no data on the effects of vonoprazan on the breastfed child or the effects on milk production. In animal studies, liver injury occurred in offspring from pregnant and lactating rats administered oral vonoprazan at AUC exposures approximately equal to and greater than the MRHD (see Data).

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VOQUEZNA and any potential adverse effects on the breastfed child from VOQUEZNA or from the underlying maternal condition.

Data

Human Data

Concentrations of vonoprazan were measured in breast milk from 15 healthy lactating women following administration of vonoprazan 20 mg once daily (N=5) or twice daily (N=10) for 4 days (not an approved duration for VOQUEZNA).

Following administration of a 20 mg vonoprazan once daily regimen, the mean average concentration (Cavg) of vonoprazan in breast milk at steady state was 7.55 ng/mL. The estimated mean total amount of vonoprazan present in breast milk over 24 hours was 0.0024 mg. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was 0.0004 mg/kg/day, representing 0.13% of the maternal weight-adjusted dose.

Following administration of a 20 mg vonoprazan twice daily dosage regimen, the mean average concentration (Cavg) of vonoprazan in breast milk at steady state was 13.3 ng/mL. The estimated mean total amount of vonoprazan present in breast milk over 24 hours was 0.009 mg. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was 0.0015 mg/kg/day, representing 0.27% of the maternal weight-adjusted dose.

Animal Data

In a PPND study in rats, in which the dams were administered oral vonoprazan during gestation and through lactation at up to 22-times the MRHD (based on a comparison of AUC), liver discoloration occurred in offspring from the high dose group [see Use in Specific Populations (8.1)].

Liver discoloration associated with necrosis, fibrosis, and hemorrhage in the offspring of dosed rats was also seen in dose-range finding studies and limited, non-standard, follow-up, mechanistic studies, including offspring in lactation only studies. These effects were reported in pups on LD 4 at doses from 3 to 100 mg/kg/day (approximately 0.2-to 22-fold the MRHD based on an AUC values extrapolated from the PPND study) and on LD 14 at doses from 10 to 100 mg/kg/day (approximately 1-to 22-fold the MRHD based on an extrapolated AUC comparisons). In mechanistic studies, liver effects were observed in offspring treated only during lactation but not in offspring from animals only treated during gestation. In some of these studies, this finding was associated with increased offspring stomach weights that was reversed along with liver discoloration by concomitant treatment with a gastrointestinal prokinetic agent.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy [see Use in Specific Populations (8.1)].

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PATIENT INFORMATION

Additions and/or revisions underlined:

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

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are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.
- Pregnancy Exposure Registry: There is a pregnancy registry for women who take VOQUEZNA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with VOQUEZNA, talk to your healthcare provider about how you can join this pregnancy registry or you can enroll in the registry by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/.
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take VOQUEZNA while breastfeeding.

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