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.

TRULANCE (NDA-208745)

(PLECANATIDE)

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

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04/13/2021 (SUPPL-11)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

New subsection added

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

Hypersensitivity Reactions: skin itching, hives, rash

Vomiting

10/29/2020 (SUPPL-10)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

(Additions and/or revisions underlined)

Risk Summary

After administration of multiple doses of TRULANCE 3 mg once daily for 2 weeks to nursing mothers, plecanatide and its active metabolite were not measurable in breast milk collected at 2 hours, 6 hours, and 12 hours post-dosing. In adults, concentrations of plecanatide and its active metabolite were mostly unmeasurable in plasma following multiple doses of TRULANCE 3 mg once daily for up to 12 weeks [see Clinical Pharmacology (12.3)].

Maternal use of TRULANCE is not expected to result in clinically relevant exposure to plecanatide or its active metabolite in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRULANCE and any potential adverse effects on the breastfed infant from TRULANCE or from the underlying maternal condition.

01/24/2018 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Diarrhea

(Additions and/or revisions are underlined)

Diarrhea was the most common adverse reaction in four placebo-controlled clinical trials, two in patients with CIC and two in patients with IBS-C. Severe diarrhea was reported in 0.6% of patients in two trials in patients with CIC and in 0.6% of patients in the two trials in patients with IBS-C…

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

…

Demographic characteristics were comparable between the TRULANCE and placebo groups in all studies.

Chronic Idiopathic Constipation (CIC)

…

Table 1: Most Common Adverse Reactions (superscript a) in Two Placebo-Controlled Trials of TRULANCE [Study 1 and Study 2] in Patients with CIC (Table Note has been revised; please refer to label)

…

Irritable Bowel Syndrome with Constipation (IBS-C)

The safety data described below reflect data from 1449 adult patients with IBS-C randomized in two double- blind, placebo-controlled clinical trials (Study 3 and Study 4) to receive placebo or 3 mg TRULANCE once daily for 12 weeks.

Most Common Adverse Reactions

Table 2 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients treated with TRULANCE and at an incidence that was greater than in the placebo group.

Table 2: Most Common Adverse Reactionsa in Two Placebo-Controlled Trials of TRULANCE [Study 3 and Study 4] in Patients with IBS-C (Table has been added; please refer to label)

Diarrhea

The majority of reported cases of diarrhea occurred within 4 weeks of treatment initiation. Severe diarrhea was reported in 1% of TRULANCE-treated patients compared to 0.1% of placebo-treated patients. Severe diarrhea was reported to occur within the first day of treatment.

Adverse Reactions Leading to Discontinuation

Discontinuations due to adverse reactions occurred in 2.5% of TRULANCE-treated patients and 0.4% of placebo-treated patients. The most common adverse reaction leading to discontinuation was diarrhea: 1.2% of TRULANCE-treated patients and 0% of placebo-treated patients withdrew due to diarrhea.

Less Common Adverse Reactions

Adverse reactions reported in 1% or more but less than 2% of TRULANCE-treated patients and at an incidence greater than placebo were: nausea, nasopharyngitis, upper respiratory tract infection, urinary tract infection, and dizziness. Two patients reported increased liver biochemical tests (alanine aminotransferase (ALT) greater than 5 to 15 times the upper limit of normal).

8 Use in Specific Populations

8.5 Geriatric Use

(Additions and/or revisions are underlined)

Chronic Idiopathic Constipation (CIC)

Of 2601 subjects in placebo-controlled clinical trials of TRULANCE, 273 (10%) were 65 years of age and over, and 47 (2%) were 75 years and over…

Irritable Bowel Syndrome with Constipation (IBS-C)

Of 1621 subjects in the placebo-controlled clinical studies of TRULANCE, 134 (8.3%) were 65 years of age and over, and 25 (1.5%) were 75 years and over. Clinical studies of TRULANCE did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from patients 18 years to less than 65 years of age.

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

Medication Guide

(Additions and/or revisions are underlined)

What is TRULANCE?

TRULANCE is a prescription medicine used in adults to treat:

a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown.
irritable bowel syndrome with constipation (IBS-C).