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.

SUPREP BOWEL PREP KIT (NDA-022372)

(MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE)

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

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11/18/2025 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.8 Hypersensitivity Reaction

Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus and urticaria have been reported with SUPREP [see Adverse Reactions (6.2)]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

6 Adverse Reactions

Additions and/or revisions underlined:

The following important adverse reactions for bowel preparations are described elsewhere in the labeling:

. . .

Hypersensitivity Reactions [see Warnings and Precautions (5.8)]

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SUPREP. 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.

Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warning and Precautions (5.8)]

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

MEDICATION GUIDE

. . .

What are the possible side effects of SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit can cause serious side effects, including:

. . .

Serious allergic reactions. Get medical help right away if you have any signs and symptoms of a serious allergic reaction while taking SUPREP Bowel Prep Kit, including:

difficulty breathing
itching
swelling of the face, lips, tongue or throat
raised red patches on your skin (hives)
skin rash

. . .

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).

Instruct patients or caregivers:

. . .

Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.8)].

. . .

Please see www.sebelapharma.com for patent information.

08/05/2020 (SUPPL-13)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

SUPREP Bowel Prep Kit is contraindicated in the following conditions:

Gastrointestinal obstruction or ileus [see Warnings and Precautions (5.6)]
Bowel perforation [see Warnings and Precaution (5.6)]
Toxic colitis or toxic megacolon Gastric retention
Hypersensitivity to any of the ingredients in SUPREP Bowel Prep Kit

5 Warnings and Precautions

5.1 Serious Fluid and Serum Chemistry Abnormalities

(Additions and/or revisions underlined)

Advise all patients to hydrate adequately before, during, and after the use of SUPREP Bowel Prep Kit. If a patient develops significant vomiting or signs of dehydration after taking SUPREP Bowel Prep Kit, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Correct fluid and electrolyte abnormalities before treatment with SUPREP Bowel Prep Kit. Use SUPREP Bowel Prep Kit with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions (7.1)].

5.4 Use in Patients with Risk of Renal Injury

(Additions and/or revisions underlined)

Use SUPREP Bowel Prep Kit with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions (7.1)]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUPREP Bowl Prep Kit and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations (8.6)].

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 SUPREP Bowel Prep Kit solution. Observe these patients during administration of SUPREP Bowel Prep Kit solution. Use with caution in these patients.

6 Adverse Reactions

(Additions and/or revisions underlined)

The following important adverse reactions for bowel preparations are described elsewhere in the labeling:

Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions (5.1)]
Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
Seizures [see Warnings and Precautions (5.3)]
Use in Patients with Risk of Renal Injury [see Warnings and Precautions (5.4)]
Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions (5.5)]
Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.6)]

Aspiration [see Warnings and Precautions (5.7)]

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Adults

The safety of SUPREP Bowel Prep Kit was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies (14)].

Most Common Adverse Reactions

Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving SUPREP Bowel Prep Kit or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens.

Laboratory Abnormalities

Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either SUPREP Bowel Prep Kit or PEG+E administered as a split-dose (2-day) regimen.

Adverse Reactions with Unapproved Use

In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with SUPREP Bowel Prep Kit as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen.

overall discomfort, abdominal distention, nausea, and vomiting
total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high). Administration of SUPREP Bowel Prep Kit in an evening-only (1-day) dosing regimen is not recommended.

Pediatrics 12 Years to 16 Years of Age

The safety of SUPREP Bowel Prep Kit was evaluated in a single dose-ranging clinical trial of 89 pediatric patients aged 12 years to 16 years [see Clinical Studies (14)]. In 26 pediatric patients who received SUPREP Bowel Prep Kit (two 4.5-ounce doses), the most common adverse reactions (> 10%) were nausea, abdominal pain, abdominal bloating, and vomiting.

7 Drug Interactions

7.2 Potential for Reduced Drug Absorption

(Additions and/or revisions underlined)

SUPREP Bowel Prep Kit can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1)].

Administer oral medications at least one hour before starting each dose of SUPREP Bowel Prep Kit.

Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of SUPREP Bowel Prep Kit to avoid chelation with magnesium.

7.3 Stimulant Laxatives

(Additions and/or revisions underlined)

Concurrent use of stimulant laxatives and SUPREP Bowel Prep Kit may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUPRPEP Bowel Prep Kit [see Warnings and Precautions (5.5)].

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

There are no available data on SUPREP Bowel Prep Kit use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (SUPREP Bowel Prep Kit).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

There are no data available data on the presence of SUPREP Bowel Prep Kit in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUPREP Bowel Prep Kit and any potential adverse effects on the breastfed child from SUPREP Bowel Prep Kit or from the underlying maternal condition.

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of SUPREP Bowel Prep Kit (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of SUPPREP Bowel Prep Kit in this age group is supported by evidence from an adequate and well-controlled trial of SUPREP Bowel Prep Kit in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies (14)]. In the pediatric trial, SUPREP Bowel Prep Kit (two 6- ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to SUPREP Bowel Prep Kit (two 4.5-ounce doses). Therefore, SUPREP Bowel Prep Kit (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration (2.3)]. The safety profile of SUPREP Bowel Prep Kit (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1)].

The safety and effectiveness of SUPREP Bowel Prep Kit in pediatric patients less than 12 years of age have not been established.

8.5 Geriatric Use

(Additions and/or revisions underlined)

Of the 375 patients who received SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when SUPREP Bowel Prep Kit was given as a one-day preparation (not a recommended regimen).

Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1)].

8.6 Renal Impairment

(Newly added subsection)

Use SUPREP Bowel Prep Kit with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of SUPREP Bowel Prep Kit and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)].

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

17 PATIENT COUNSELING INFORMATION

(Extensive changes; please refer to label)

MEDICATION GUIDE

(Newly added)