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.

VYXEOS (NDA-209401)

(CYTARABINE; DAUNORUBICIN)

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

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01/27/2026 (SUPPL-18)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Newly Diagnosed t-AML or AML-MRC

The safety and effectiveness of VYXEOS have been established in pediatric patients 1 year and older with newly diagnosed tAML or AML-MRC. The use of VYXEOS for this indication is supported by evidence of effectiveness from an adequate and well-controlled study in adults with data on safety from two single-arm trials, which included patients in the following age groups: 7 patients 1 year to less than 2 years old, 33 patients 2 years to less than 12 years old, 13 patients 12 years old to less than 17 years old. The exposures of total daunorubicin and cytarabine observed in pediatric patients were within the values observed in adults given the same dose based on body surface area [see Clinical Pharmacology (12.3)]. No new safety signals were observed in pediatric patients in these two single-arm trials. No differences in safety were observed by age. The safety and effectiveness of VYXEOS in pediatric patients less than 1 year of age with newly diagnosed t-AML or AML-MRC have not been established.

Newly Diagnosed de novo AML

The safety and effectiveness of VYXEOS in pediatric patients with de novo AML were assessed but not established in an open-label, randomized study (NCT04293562) comparing VYXEOS plus gemtuzumab ozogamicin to standard chemotherapy plus gemtuzumab ozogamicin. The VYXEOS arm included 324 pediatric patients less than 17 years old. No new safety signals were identified in the pediatric patients treated with VYXEOS and gemtuzumab ozogamicin in this trial.

09/27/2022 (SUPPL-11)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

New subsection added

The following adverse reactions have been identified during postmarketing use of VYXEOS. 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:

- Infusion-related reactions

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined

Dosage adjustment is not required for patients with mild (creatinine clearance [CLCR] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]), moderate (CLCR 30 mL/min to 59 mL/min) or severe (CLCR 15 mL/min to 29 mL/min) renal impairment. VYXEOS has not been studied in patients with end-stage renal disease on hemodialysis [see Clinical Pharmacology (12.3)].

03/30/2021 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Tissue Necrosis

(Additions and/or revisions underlined)

Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Confirm patency of the intravenous access before administration. Do not administer by the intramuscular or subcutaneous route.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of VYXEOS have been established in pediatric patients 1 year and older with newly diagnosed t-AML or AML-MRC. The use of VYXEOS for this indication is supported by evidence of effectiveness from an adequate and well-controlled study in adults with data on safety from two single-arm trials, which included patients in the following age groups: 7 patients 1 year to less than 2 years old, 33 patients 2 years to less than 12 years old, 13 patients 12 years old to less than 17 years old. [see Clinical Pharmacology (12.3)]. No new safety signals were observed in pediatric patients in these two single-arm trials. No differences in safety were observed by age. The safety and effectiveness of VYXEOS in pediatric patients less than 1 year of age with newly-diagnosed t-AML or AML-MRC have not been established.