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.

ZINECARD (NDA-020212)

(DEXRAZOXANE HYDROCHLORIDE)

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

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05/12/2025 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Embryo-Fetal Toxicity

Additions and/or revisions underlined:

Based on finding from animal studies and its mechanism of action, ZINECARD can cause fetal harm when administered to pregnant women [see Clinical Pharmacology (12.1)]. In animal reproduction studies, dexrazoxane administration during the period of organogenesis resulted in maternal toxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus.Advise females of reproductive potential to use effective contraception during treatment with ZINECARD and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZINECARD and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

Based on findings from animal studies and its mechanism of action, ZINECARD can cause fetal harm when administered to pregnant women [see Clinical Pharmacology (12.1)]. Available human data with ZINECARD use in pregnant women is not sufficient to inform the

drug-associated risk. In animal reproduction studies, dexrazoxane administration resulted in maternal toxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. 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

Animal Data

Dexrazoxane resulted in maternal toxicity in rats at doses of greater than or equal to 2 mg/kg (1/40 the human dose on a mg/m2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) when given daily to pregnant rats during the period of organogenesis.

Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of greater than or equal to 5 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung.

8.2 Lactation

PLLR conversion:

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of dexrazoxane or its metabolites in human milk, the effects on a breastfeed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ZINECARD and for 2 weeks after the last dose.

8.3 Females and Males of Reproductive Potential

PLLR conversion:

ZINECARD can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to starting treatment with ZINECARD.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with ZINECARD and for 6 months after the last dose.

Males

Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZINECARD and for 3 months after the last dose [see Nonclinical Toxicology (13.1)].

Infertility

Based on findings from animal studies, ZINECARD may impair male fertility [see Nonclinical Toxicology (13.1)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Embryo-Fetal Toxicity

Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with ZINECARD and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZINECARD and for 3 months after the last dose [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with ZINECARD and for 2 weeks after the last

dose [see Use in Specific Populations (8.2)].

Infertility

Advise males of reproductive potential that ZINECARD may impair fertility [see Use in Specific

Populations (8.3)].

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com. For medical information about ZINECARD, please visit www.pfizermedinfo.com or call 1-800-438-1985.