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.

RELEUKO (BLA-761082)

(FILGRASTIM-AYOW)

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

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04/29/2025 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Leukocytosis

Additions and/or revisions underlined:

. . .

Peripheral Blood Progenitor Cell Collection and Therapy

During the period of administration of RELEUKO for PBPC mobilization in patients with cancer, discontinue RELEUKO if the leukocyte count rises to > 100,000/mm3.

5.12 Potential Effect of Malignant Cells

Additions and/or revisions underlined:

. . .

When RELEUKO is used to mobilize PBPC‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied‚ and the limited data available are inconclusive.

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added table; please refer to label for complete information

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

The use of RELEUKO to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on studies of filgrastim conducted in animals and clinical data supporting the use of filgrastim in other approved indications [see Dosage and Administration (2.1 to 2.4) and Clinical Studies (14.6)].

8.5 Geriatric Use

Additions and/or revisions underlined:

. . .

Clinical studies of filgrastim in other approved indications (i.e., BMT recipients, PBPC mobilization, and SCN) did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of filgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.6)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

What is RELEUKO?

RELEUKO is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Acute Radiation Syndrome: The effectiveness of filgrastim for this use was only studied in animals, because it could not be studied in people.

. . .

If you are receiving RELEUKO because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with RELEUKO to check your white blood cell count.

. . .

The most common side effects experienced in patients receiving RELEUKO include:

Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

. . .

09/01/2023 (SUPPL-10)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or 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.

splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions (5.1)]
acute respiratory distress syndrome [see Warnings and Precautions (5.2)]
anaphylaxis [see Warnings and Precautions (5.3)]
sickle cell disorders [see Warnings and Precautions (5.4)]
glomerulonephritis [see Warnings and Precautions (5.5)]
alveolar hemorrhage and hemoptysis [see Warnings and Precautions (5.6)]
capillary leak syndrome [see Warnings and Precautions (5.7)]
leukocytosis [see Warnings and Precautions (5.10)]
cutaneous vasculitis [see Warnings and Precautions (5.11)]
Sweet’s syndrome (acute febrile neutrophilic dermatosis)
decreased bone density and osteoporosis in pediatric patients receiving chronic treatment with filgrastim products
myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions (5.8)]
aortitis [see Warnings and Precautions (5.15)]
extramedullary hematopoiesis