Drug Safety-related Labeling Changes (SrLC)
Get Email Alerts |
Guide
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.
ZARXIO (BLA-125553)
(FILGRASTIM-SNDZ)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
10/22/2024 (SUPPL-38)
08/09/2024 (SUPPL-35)
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions and revisions underlined:
The following adverse reactions have been identified during post-approval use of filgrastim products. 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.
. . .
extramedullary hematopoiesis
8 Use in Specific Populations
8.4 Pediatric UseAdditions and revisions underlined:
ZARXIO prefilled syringe with BD UltraSafe Passive® Needle Guard may not accurately measure volumes less than
0.3 mL due to the needle spring mechanism design. Therefore, the direct administration of a volume less than 0.3 mL using ZARXIO prefilled syringe is not recommended due to the potential for dosing errors. For direct administration of doses less than 0.3 mL (180 mcg) use ZARXIO single-dose vial.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and revisions underlined:
. . .
If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of ZARXIO or whether the patient would benefit from a different ZARXIO presentation.
. . .
Instruct patients who self-administer ZARXIO using the prefilled syringe or single-dose vial of the:
Importance of following the applicable Instructions for Use.
Dangers of reusing needles, syringes or unused portions of single-dose vials.
Importance of following local requirements for proper disposal of used syringes, needles, and unused vials.
Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the ZARXIO prefilled syringe. If difficulties occur, use of the ZARXIO vial may be considered.
Additions and revisions underlined:
Ask your healthcare provider about using the vial if you have latex allergies. The vial stopper is not made with natural rubber latex.
How should I store ZARXIO?
Store ZARXIO in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze.
Store ZARXIO in the original pack to protect it from light or physical damage. Do not leave ZARXIO in direct sunlight.
Do not shake ZARXIO.
Take ZARXIO out of the refrigerator 30 minutes before use and allow it to reach room temperature between 68°F to 77°F (20°C to 25°C) before preparing an injection.
If not used right away, ZARXIO may be kept at room temperature for up to 8 days. Throw away any ZARXIO that has been left at room temperature for longer than 8 days.
After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe or vial. Do not
save unused ZARXIO in the prefilled syringe or vial for later use.