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.

ZUPLENZ (NDA-022524)

(ONDANSETRON)

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

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08/05/2021 (SUPPL-7)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Extensive revisions – please refer to labeling)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions underlined)

Risk Summary

It is not known whether ondansetron is present in human milk. There are no data on the effects of ZUPLENZ on the breastfed infant or the effects on milk production. However, it has been demonstrated that ondansetron is present in the milk of rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

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

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of ZUPLENZ have been established in pediatric patients 4 years of age and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Use of ZUPLENZ in these age-groups is supported by evidence from adequate and well-controlled studies of ondansetron HCl in adults with additional data from 3 open-label, uncontrolled, non-US trials in 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see Dosage and Administration (2.1), Clinical Studies (14.1)].

The safety and effectiveness of ZUPLENZ have not been established in pediatric patients for:

prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy
prevention of nausea and vomiting associated with radiotherapy
prevention of postoperative nausea and/or vomiting.

8.5 Geriatric Use

(Additions and/or revisions underlined)

Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and non-US- controlled clinical trials of oral ondansetron, for which there were subgroup analyses, 938 (19%) were 65 years of age and over.

No overall differences in safety or effectiveness were observed between these subjects 65 years of age and older and younger subjects. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared to younger subjects [see Clinical Pharmacology (12.3)]. There were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. 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. No dosage adjustment is needed in elderly patients.

8.6 Renal Impairment

(Additions and/or revisions underlined)

No dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe. There is no experience beyond first-day administration of ondansetron [see Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

(Additions and/or revisions underlined)

No dosage adjustment is needed in patients with mild or moderate hepatic impairment.

In patients with severe hepatic impairment, clearance is reduced, and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron. Therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (Child-Pugh score of 10 or greater) [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)].

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

17 PATIENT COUNSELING INFORMATION

(Extensive changes; please refer to labeling)