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.

FOTIVDA (NDA-212904)

(TIVOZANIB HYDROCHLORIDE)

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

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08/06/2024 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Gastrointestinal Perforation and Fistula Formation

Newly added subsection:

Gastrointestinal perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening gastrointestinal perforation.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Gastrointestinal Perforation and Fistula Formation [see WARNINGS AND PRECAUTIONS (5.7)]

6.2 Postmarketing Experience

Newly added subsection:

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

Gastrointestinal disorders: Gastrointestinal perforation and pancreatitis

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Perforations and Fistulas

Inform patients that gastrointestinal perforations or fistulas may develop during FOTIVDA treatment. Advise patients to immediately contact their healthcare provider if they experience persistent or severe abdominal pain [see WARNINGS AND PRECAUTIONS (5.7)].

PATIENT INFORMATION

Additions and/or revisions underlined:

What are the possible side effects of FOTIVDA?

FOTIVDA may cause serious side effects, including:

…

Tear (perforation) in your stomach or intestines or an abnormal connection between two or more body parts (fistula). Get medical help right away if you experience tenderness or pain in your stomach-area (abdomen) that is severe and does not go away.