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.

PLENVU (NDA-209381)

(ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE)

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

Download Data

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09/08/2023 (SUPPL-13)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Follow the directions in the Instructions for Use, for either the Two-Day Split Dosage or the One-Day Morning Dosage regimen, as prescribed.
Reconstitute each pouch of PLENVU in the mixing container with water before ingestion and drink additional clear liquids. Examples of clear liquids can be found in the Instructions for Use. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
Consume additional clear liquids before, during, and after the use of PLENVU to prevent dehydration [see Warnings and Precautions (5.1)].
Consume only clear liquids (no solid food) from the start of PLENVU treatment until after the colonoscopy.
…

05/14/2021 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Aspiration

Additions and/or revisions underlined:

Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of PLENVU. Observe these patients during the administration of PLENVU. Use with caution in these patients.

Do not combine PLENVU with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of PLENVU, when mixed with starch- thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG- based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

PLENVU may affect how other medicines work. Do not take medicines by mouth 1 hour before or after starting each dose of PLENVU.

Especially tell your healthcare provider if you take:

Newly added:

starch based thickeners. For patients who have trouble swallowing, do not mix PLENVU with starch-based thickeners

05/29/2019 (SUPPL-2)

Approved Drug Label (PDF)

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

MEDICATION GUIDE

(additions underlined)

…

How should I take PLENVU?

See the “Instructions for Use” for dosing instructions. You must read, understand, and follow these instructions to take PLENVU the right way.

Take PLENVU exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you to take the Two-Day Split-Dosing option or the One-Day Morning Dosing option.
Drink clear liquids before, during, and after you take PLENVU, up until 2 hours before your colonoscopy, to help prevent fluid loss (dehydration) and changes in blood salt (electrolyte) levels.

…