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.

ENTEREG (NDA-021775)

(ALVIMOPAN)

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

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11/17/2020 (SUPPL-18)

Approved Drug Label (PDF)

Boxed Warning

In the second paragraph, Alvimopan REMS replaces the ENTEREG Access Support and Education (E.A.S.E.)

5 Warnings and Precautions

WARNINGS AND PRECAUTIONS

Additions and/or revisions underlined:

5.2 Alivmopan REMS Program

Alvimopan REMS replaces E.A.S.E. throughout subsection

www.alvimopanREMS.com replaces www.ENTEREGREMS.com

6 Adverse Reactions

Newly added bulleted line listing:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Potential Risk of Myocardial Infarction with Long-Term Use [see Warnings and Precautions (5.1)]
Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients [see Warnings and Precautions (5.3)]
Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment [see Warnings and Precautions (5.4)]
Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction [see Warnings and Precautions (5.6)]
Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses [see Warnings and Precautions (5.7)]

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

PATIENT COUNSELING INFORMATION

Hospital Use Only

Alvimopan REMS replaces E.A.S.E.

Other

The Single Shared System REMS (Alvimopan REMS) replaces the ENTEREG Access Support and Education (E.A.S.E.) REMS

10/10/2019 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 E.A.S.E. ENTEREG REMS Program

Further information is available at www.ENTEREGREMS.com or 1-800-278-0340. (Updated phone number)

Additions and/or revisions underlined:

5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment

Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma concentrations of alvimopan have been observed in such patients compared with patients with normal hepatic function.

7 Drug Interactions

7.2 Effects of Concomitant Acid Blockers or Antibiotics

Additions and/or revisions underlined:

A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers (proton pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists) or antibiotics.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; please refer to label for complete information.

8.2 Lactation

PLLR conversion; as below:

Risk Summary

There are no data on the presence of alvimopan in human milk, the effects on the breastfed infant, or the effects on milk production. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats following intravenous administration. It is unknown if alvimopan is present in rat milk following oral administration.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ENTEREG and any potential adverse effects on the breastfed child from ENTEREG or from the underlying maternal condition.

Data

Following intravenous administration of alvimopan to lactating rats at 10 mg/kg/day, concentrations of alvimopan and its ‘metabolite’ in the milk were approximately 15- and 0.11-fold, respectively, the concentration of alvimopan in maternal plasma at 1-hour post-dose.

8.8 Race/Ethnicity