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.

MATULANE (NDA-016785)

(PROCARBAZINE HYDROCHLORIDE)

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

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09/30/2026 (SUPPL-44)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

Based on findings from human case reports and animal studies, MATULANE can cause fetal harm when administered to a pregnant woman (see Data). In reproductive studies in rats, procarbazine hydrochloride caused adverse developmental outcomes including embryo-fetal mortality, structural abnormalities, and neurogenic tumors.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus.

Advise females of reproductive potential to use effective contraception during treatment with MATULANE.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

Data

Human

There are case reports of malformations in the offspring of women exposed to procarbazine hydrochloride in combination with other antineoplastic agents during pregnancy.

Animal

Procarbazine hydrochloride caused embryo-fetal mortality and structural abnormalities in rats when administered intraperitoneally at doses approximately 1.5 to 4.5 times the maximum recommended human therapeutic dose of 100 mg/m2 based on body surface area.

Procarbazine hydrochloride has not been adequately studied in animals for its effects on peri- and postnatal development. However, neurogenic tumors developed in the offspring of rats that were intravenously administered procarbazine hydrochloride on day 22 of gestation at a dose approximately 7.5 times the maximum recommended human therapeutic dose of 100 mg/m2 based on body surface area.

8.2 Lactation

PLLR conversion:

Risk Summary

There are no data on the presence of MATULANE or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions, including tumorigenicity in the breastfed child, advise women not to breastfeed during treatment with MATULANE.

Other

PLLR conversion; please refer to label for complete information

Physician Labeling Rule (PLR) conversion, please refer to label for complete information