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.

KAYEXALATE (NDA-011287)

(SODIUM POLYSTYRENE SULFONATE)

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

Download Data

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07/28/2017 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Risk of Aspiration

(new subsection added)

Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles have been reported. Patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. Administer KAYEXALATE with the patient in an upright position.

5.5 Binding to Other Orally Administered Medications

(new subsection added)

KAYEXALATE may bind orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 3 hours before or 3 hours after KAYEXALATE. Patients with gastroparesis may require a 6 hour separation.

6 Adverse Reactions

(section revised)

The following adverse reactions are discussed elsewhere in the labeling:I

Intestinal Necrosis

Electrolyte Disturbances
Aspiration

7 Drug Interactions

7.1 General Interactions

(new subsection added)

No formal drug interaction studies have been conducted in humans.

KAYEXALATE has the potential to bind other drugs. In in vitro binding studies, KAYEXALATE was shown to significantly bind the oral medications (n=6) that were tested. Decreased absorption of lithium and thyroxine have also been reported with co-administration of KAYEXALATE. Binding of KAYEXALATE to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time KAYEXALATE is administered. Administer KAYEXALATE at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation. Monitor for clinical response and/or blood levels where possible.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

KAYEXALATE is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

8.2 Lactation

(PLLR conversion)

Risk Summary

KAYEXALATE is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

Other

(revisions to labeling to comply with the Physician’s Labeling Rule (PLR)).