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.

NIPENT (NDA-020122)

(PENTOSTATIN)

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

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11/03/2025 (SUPPL-21)

Approved Drug Label (PDF)

8 Use in Specific Populations

Additions and/or revisions underlined:

Impairment of Fertility: No fertility studies have been conducted in animals; however, in a 5-day intravenous toxicity study in dogs, mild seminiferous tubular degeneration was observed with doses of 1 and 4 mg/kg. The possible adverse effects on fertility in humans have not been determined. Advise patients on the potential risks for infertility.

Contraception in Males and Females

Due to the genotoxicity and embryo-fetal toxicity findings in nonclinical studies, advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of NIPENT.

Due to the genotoxicity findings in nonclinical studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months following the last dose of NIPENT.

Pregnancy (See WARNINGS) Nursing Mothers

It is not known whether NIPENT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the breast-fed child due to pentostatin, advise patients not to breast-feed while on NIPENT therapy and for 1 week following the last dose of treatment.

…

10/28/2019 (SUPPL-15)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing Experience

(new subsection added)

The following adverse reactions have been identified during post-approval use of NIPENT. 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.

Hematologic System—Febrile Neutropenia, Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura, Autoimmune Thrombocytopenia

Respiratory System—Acute Respiratory Failure

Skin and Appendages—Exfoliative Dermatitis