Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

HYLENEX RECOMBINANT (BLA-021859)

(HYALURONIDASE RECOMBINANT HUMAN)

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

Download Data

Expand all

01/12/2024 (SUPPL-31)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

There are no adequate and well-controlled studies of HYLENEX recombinant administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of HYLENEX recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. Administration of HYLENEX recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses.

Human Data

Limited available data with HYLENEX recombinant in pregnant women have not identified any potential risks.

Animal Data

In an embryofetal development study, subcutaneous administration of hyaluronidase to pregnant mice throughout organogenesis produced reduced fetal weight and increased numbers of fetal resorptions at daily doses greater or equal to 3 mg/kg (approximately 360,000 USP units/kg). No malformations were produced at any dose up to approximately 18 mg/kg (approximately 2,200,000 USP units/kg). These doses are several orders of magnitude greater than the maximum recommended human dose (5 USP units/kg).

In a pre- and postnatal development study, mice were dosed daily by subcutaneous injection with hyaluronidase at dose levels up to 9 mg/kg (approximately 1,100,000 USP units/kg). The study found no adverse effects on sexual maturation, learning and memory of offspring, or their ability to produce another generation of offspring.

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There is no information regarding the presence of HYLENEX recombinant in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of HYLENEX recombinant to an infant during lactation.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HYLENEX recombinant.

01/21/2016 (SUPPL-23)

Approved Drug Label (PDF)

7 Drug Interactions

addition of information on incompatibility between Hylenex recombinant (hyaluronidase human injection) and sodium metabisulfite