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.

DOCETAXEL (NDA-202356)

(DOCETAXEL)

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

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09/24/2018 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hypersensitivity Reactions

Addition of the following to the end of the first paragraph in the subsection:

Cross-hypersensitivity between paclitaxel and docetaxel has been reported. This may include more severe reactions such as anaphylactic reactions. These patients should be closely monitored during initiation of docetaxel therapy.

6 Adverse Reactions

Addition of the following bullets to the initial line listing:

Acute Myeloid Leukemia
Cutaneous Reactions
Neurologic Reactions
Eye Disorders
Asthenia
Alcohol Intoxication

6.1 Postmarketing Experiences

Newly added information to the endings of the following headings:

Body as a whole

… injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed.

Hypersensitivity

... Hypersensitivity reactions have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

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

PATIENT INFORMATION

Revised in entirety; please refer to label for complete information.

11/21/2017 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

(Additions and/or revisions are underlined)

The most serious adverse reactions from Docetaxel Injection are:

Acute Myeloid Leukemia
Cutaneous Reactions
Neurologic Reactions
Eye Disorders
Asthenia
Alcohol Intoxication

6.1 Post-marketing Experiences

(Additions and/or revisions are underlined)

Cutaneous: … Severe hand and foot syndrome has been reported. Cases of permanent alopecia have been reported.

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

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

(Additions and/or revisions are underlined)

Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.

Patient Information DOCETAXEL (doe-se-TAKS-el) INJECTION for intravenous use

(Extensive changes; please refer to label)