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.

TIGLUTIK KIT (NDA-209080)

(RILUZOLE)

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

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09/11/2025 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.4 Pancreatitis

Acute pancreatitis, including fatal and non-fatal necrotizing pancreatitis, has been observed in patients treated with riluzole in the postmarketing setting. Pancreatitis has occurred weeks to several years after initiation of riluzole.

Patients and caregivers should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is suspected promptly discontinue TIGLUTIK and initiate appropriate management. If an alternative cause is identified, reinitiation of TIGLUTIK may be considered.

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions are described below and elsewhere in the labeling:

Hepatic Injury [see Warnings and Precautions (5.1)]
Neutropenia [see Warnings and Precautions (5.2)]
Interstitial Lung Disease [see Warnings and Precautions (5.3)]
Pancreatitis [see Warnings and Precautions (5.4)]

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

Additions and/or revisions underlined:

. . .

Pancreatitis

Advise patients that TIGLUTIK can cause pancreatitis and to report to their healthcare provider if they have abdominal pain, nausea, vomiting, and/or anorexia [see Warnings and Precautions (5.4)].

. . .

05/11/2020 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing Experience

(Additions and/or revisions underlined)

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

Acute hepatitis and icteric toxic hepatitis [see Warnings and Precautions (5.1)]
Renal tubular impairment
Pancreatitis

12/13/2019 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

(additions underlined)

Risk Summary

There are no data on the presence of riluzole in human milk, the effects on the breastfed infant, or the effects on milk production. Riluzole or its metabolites have been detected in milk of lactating rat. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TIGLUTIK and any potential adverse effects on the breastfed infant from TIGLUTIK or from the underlying maternal condition.

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Administration Instructions

Instruct patients to discard any unused TIGLUTIK after 15 days of opening the bottle. If the patient requires administration of TIGLUTIK via PEG tube, refer the patient/caregiver to the Instructions for Use for steps on how to take/give TIGLUTIK.

…

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during TIGLUTIK therapy.

Lactation

Advise patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed during TIGLUTIK therapy.