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.

FRUZAQLA (NDA-217564)

(FRUQUINTINIB)

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

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02/28/2025 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Table 3: Adverse Reactions (greater than or equal to 10%) in Patients who Received FRUZAQLA and with a Difference Between Arms of greater than or equal to 5% Compared to Placebo in FRESCO-2 (All Grades)

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Other important adverse reactions (all grades) that occurred in <10% of patients treated with FRUZAQLA included urinary tract infection (4.6%), epistaxis (3.9%), proctalgia (3.5%), pneumonia (2.4%), gastrointestinal hemorrhage (1.5%), gastrointestinal perforation (1.3%), pancreatitis (0.7%), thrombotic microangiopathy (0.2%), and posterior reversible encephalopathy syndrome (0.2%).

…

Table 4: Select Laboratory Abnormalities Worsening from Baseline Occurring in ?20% of Patients in FRESCO-2

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Other clinically relevant laboratory abnormalities (all grades) that occurred in <20% of patients treated with FRUZAQLA included pancreatic enzymes increased (3.9%).

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Table 6: Select Laboratory Abnormalities Worsening from Baseline Occurring in ?20% of Patients in FRESCO

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Other clinically relevant laboratory abnormalities (all grades) that occurred in <20% of patients treated with FRUZAQLA included pancreatic enzymes increased (4.3%).

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Pregnancy Testing

Verify pregnancy status of females of reproductive potential prior to initiating FRUZAQLA.

Contraception

Females and Males

Females of childbearing potential and males with female partners of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose of FRUZAQLA [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.1)].

Infertility

Females and Males

There are no data on the effects of fruquintinib on human fertility. Based on findings in animal studies, FRUZAQLA may impair female fertility [see Nonclinical Toxicology (13.1)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Infertility

Advise females of reproductive potential that FRUZAQLA may cause post-implantation loss [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

PATIENT INFORMATION

Additions and/or revisions underlined:

…

The most common side effects of FRUZAQLA include:

…

FRUZAQLA may cause fertility problems in females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of FRUZAQLA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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