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.

MOZOBIL (NDA-022311)

(PLERIXAFOR)

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

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09/21/2023 (SUPPL-23)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Mozobil [see Use in Specific Populations (8.1)].

Contraception

Females
Mozobil can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with Mozobil and for one week after the final dose.

Males

Males treated with Mozobil should use effective contraception during treatment and for one week after cessation of treatment

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Advise females and males of reproductive potential to use effective contraceptive methods during Mozobil use and for 1 week following cessation of treatment [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)]. Advise women not to breastfeed during treatment with Mozobil and for 1 week following the last dose [Use in Specific Populations (8.2)].

Other

G-CSF replaced with Filgrastim throughout the label.

08/19/2020 (SUPPL-22)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Newly added information:

The safety and effectiveness of Mozobil have not been established in pediatric patients. Effectiveness was not demonstrated in a single phase 1/2 randomized, open-label, comparative study of Mozobil plus standard regimens for mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Forty-five pediatric patients ages 1 to <17 years with solid tumors or lymphoma were randomized 2:1 to Mozobil in addition to standard mobilization regimens (N=30) or standard mobilization regimens alone (N=15) (comparator arm). No new safety signals were observed in pediatric patients in this trial.

The day prior to the first apheresis, median peripheral blood CD34+ counts were 35 × 106 cells/L in the comparator arm and 15 × 106 cells/L in the Mozobil arm. On the day of the first apheresis, median peripheral blood CD34+ counts were 64 × 106 cells/L in the comparator arm and 77 × 106 cells/L in the Mozobil arm.

Plerixafor exposure, shown as AUC, in pediatric patients aged 12 to 18 years was within the range of values previously observed in adults, while the AUC of plerixafor in pediatric patients aged 2 to 12 years was 67% to 87% of that observed in adults, given the same adult dose (0.24 mg/kg).

05/30/2019 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Embryo-Fetal Toxicity

Additions and/or revisions underlined:

Based on findings from animal reproduction studies, Mozobil can cause fetal harm when administered to a pregnant woman. Plerixafor administration to pregnant rats during organogenesis resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth at exposures approximately 10 times the exposure at the recommended human dose.

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use an effective form of contraception during treatment with Mozobil and for one week after the final dose.

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

PLLR conversion; please refer to label for complete information.

8.4 Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness have not been established in pediatric patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with Mozobil.

Advise females of reproductive potential to use effective contraceptive methods during Mozobil use and for 1 week following the last dose.

12/01/2017 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Splenic Enlargement and Rupture

(Subsection title has been revised; additions and/or revisions are underlined)

…

Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF…

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Blood and lymphatic system: Splenomegaly and splenic rupture

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

…

Advise patients to contact health care professional immediately if they experience left upper abdominal pain and/or scapular or shoulder pain.