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.

GEMZAR (NDA-020509)

(GEMCITABINE HYDROCHLORIDE)

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

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05/14/2019 (SUPPL-82)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hemolytic Uremic Syndrome

Newly added information to end of 1st paragraph:

Serious cases of thrombotic microangiopathy other than HUS have been reported with GEMZAR.

5.6 Embryo-Fetal Toxicity

Addition of pregnant in front of women.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Exacerbation of Radiation Therapy Toxicity
Following Table 6, Ovarian Cancer replaces Small Cell Lung Cancer.
Newly added information:
Tables 7 and 8 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in greater than or equal to10% of GEMZAR-treated patients and at a higher incidence in the GEMZAR with carboplatin arm, reported in a randomized trial (Study 1) of GEMZAR with carboplatin (n=175) compared to carboplatin alone (n=174) for the second-line treatment of ovarian cancer in women with disease that had relapsed more than 6 months following first-line platinum-based chemotherapy. Additional clinically significant adverse reactions, occurring in <10% of patients, are provided following Table 8.
Table title revised, as below:
Table 7: Adverse Reactions Occurring in >10% of Patients Receiving Gemcitabine with Carboplatin and at Higher Incidence than in Patients Receiving Single Agent Carboplatin [Between Arm Difference of greater than or equal to 5% (All Grades) or greater than or equal to 2% (Grades 3-4)] in Study 1a
Breast Cancer
Newly added information:
Tables 9 and 10 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in greater than or equal to10% of GEMZAR-treated patients and at a higher incidence in the GEMZAR with paclitaxel arm, reported in a randomized trial (Study 2) of GEMZAR with paclitaxel (n=262) compared to paclitaxel alone (n=259) for the first-line treatment of metastatic breast cancer (MBC) in women who received anthracycline-containing chemotherapy in the adjuvant/neo- adjuvant setting or for whom anthracyclines were contraindicated. Additional clinically significant adverse reactions, occurring in <10% of patients, are provided following Table 10.
Following Table 10, additions and/or revisions underlined:
Non-Small Cell Lung Cancer
Tables 11 and 12 present the incidence of selected adverse reactions and …
6.2 Postmarketing Experience
Additions and/or revisions underlined in bulleted line listing:
Blood and lymphatic system: Thrombotic microangiopathy (TMA)
Pulmonary: … (ARDS), pulmonary eosinophilia

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Contraception

Males

Final replaces last in this sentence.

11/20/2018 (SUPPL-81)

Approved Drug Label (PDF)

Other

Physician Labeling Rule (PLR) and the Pregnancy and Lactation Labeling Rule (PLLR) conversion; extensive changes – please refer to labeling

09/13/2017 (SUPPL-79)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

… The maximum tolerated dose was 10 mg/m2/min for 360 minutes weekly for three weeks followed by a one-week rest period. The safety and activity of Gemzar were evaluated in a trial of pediatric patients with relapsed acute lymphoblastic leukemia (22 patients) and acute myelogenous leukemia (10 patients) at a dose of 10 mg/m2/min administered over 360 minutes weekly for three weeks followed by a one-week rest period. Patients with M1 or M2 bone marrow on Day 28 who did not experience unacceptable toxicity were eligible to receive a maximum of one additional four-week course. Toxicities observed included …