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.

RENAGEL (NDA-021179)

(SEVELAMER HYDROCHLORIDE)

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

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04/30/2020 (SUPPL-38)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Gastrointestinal Adverse Events

(additions underlined)

Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the Renagel clinical studies.

…

Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use.

Inflammatory disorders may resolve upon Renagel discontinuation. Treatment with Renagel should be re-evaluated in patients who develop severe gastrointestinal symptoms.

6 Adverse Reactions

6.2 Postmarketing Experience

(additions underlined)

The following adverse reactions have been identified during postapproval use of sevelamer hydrochloride (Renagel): hypersensitivity, pruritus, rash, abdominal pain, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, fecal impaction and uncommon cases of ileus, intestinal obstruction, and intestinal perforation. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.

…

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their healthcare provider.

02/21/2019 (SUPPL-37)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Gastrointestinal Adverse Events

(Additions and/or revisions are underlined)

Dysphagia and esophageal tablet retention have been reported in association with use of sevelamer tablets, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.

Cases of bowel obstruction and perforation have also been reported with sevelamer use.

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

Risk Summary

Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.

Clinical Considerations

Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women. Consider supplementing with these vitamins.

Data

Animal data

In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of Renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat- soluble vitamin D, occurred at 7-21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of Renagel by gavage during organogenesis, an increase of early resorptions occurred in the high- dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight).

8.2 Lactation

(Additions and/or revisions are underlined)

Risk Summary

Renagel is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to Renagel.

Clinical Considerations

Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in lactating women. Consider supplementing with these vitamins.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise patients to take Renagel with meals and adhere to their prescribed diets.

Provide instructions on concomitant medications that should be dosed apart from Renagel.

Advise patients to report new onset or worsening of existing constipation promptly to their healthcare provider.

03/09/2016 (SUPPL-32)

Approved Drug Label (PDF)

4 Contraindications

Renagel is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients.

6 Adverse Reactions

Postmarketing Experience

Hypersensitivity