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.

ONUREG (NDA-214120)

(AZACITIDINE)

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

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04/09/2026 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Myelosuppression

Additions and/or revisions underlined:

New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG, respectively. Febrile neutropenia occurred in 12%, and sepsis was reported in 6%, including 1 fatal case. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively. Less than 1% of patients discontinued ONUREG due to either neutropenia or thrombocytopenia.

Monitor complete blood counts and modify the dosage as recommended [see Dosage and Administration (2.2, 2.3)]. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Acute Myeloid Leukemia

. . .

The most common (greater than or equal to 10%) adverse reactions were nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, skin infection, and pain in extremity.

Table 2 summarizes the adverse reactions in QUAZAR.

Table 2: Adverse Reactions (greater than or equal to 5%) in Patients with AML Who Received ONUREG with a Difference Between Arms of > 2% Compared to Placebo in QUAZAR

Extensive changes to table; please refer to label for complete information.

Clinically relevant adverse reactions in less than 5% of patients who received ONUREG included

Investigations: Weight decreased

. . .

8 Use in Specific Populations

8.7 Hepatic Impairment

Additions and/or revisions underlined:

ONUREG has not been studied in patients with pre-existing severe hepatic impairment (total bilirubin > 3 × ULN).

No dose adjustment of ONUREG is recommended for patients with mild or moderate hepatic impairment (total bilirubin less than or equal to ULN and AST > ULN, or total bilirubin 1 to 3× ULN and any AST) [see Clinical Pharmacology (12.3)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Myelosuppression

Advise patients of the risk of myelosuppression with ONUREG and of the need to monitor complete blood counts before and during treatment [see Warnings and Precautions (5.2)].

Infection

Advise patients of the risk of infections, including sepsis, with ONUREG and to report any symptoms of infection to their healthcare provider as soon as possible [see Adverse Reactions (6.1)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

What are the possible side effects of ONUREG? ONUREG can cause serious side effects, including:

New or worsening low white blood cell counts (neutropenia). New or worsening low white blood cell counts can be severe during treatment with ONUREG. If your white blood cell counts become very low, you are at increased risk for infections, including a severe infection of the blood called sepsis that can lead to death. Your healthcare provider will check your white blood cell counts before and during treatment with ONUREG. Your healthcare provider may prescribe a medicine to help increase your white blood cell count if needed.

Tell your healthcare provider right away if you get any of the following symptoms:

. . .

lightheadedness or dizziness
shortness of breath
confusion or grogginess
fast heartbeat

. . .

The most common side effects of ONUREG include:

. . .

low white blood cell counts

. . .

sore throat and runny nose
skin infection

. . .