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.

AEROSPAN HFA (NDA-021247)

(FLUNISOLIDE)

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

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04/25/2018 (SUPPL-17)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There is no information on the presence of flunisolide in human milk, or the effects on the breast fed child, or the effects on milk production following use of flunisolide. Because other corticosteroids are excreted in human milk, caution should be exercised when AEROSPAN is administered to nursing women.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AEROSPAN and any potential adverse effects on the breastfed infant from AEROSPAN or from the underlying maternal condition.

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There are no studies with AEROSPAN in pregnant women to inform a drug-associated risk for birth defects or miscarriage. There are clinical considerations with use of AEROSPAN in pregnant women to inform a drug-associated risk. In animal reproduction studies, flunisolide administered to pregnant rats and rabbits during the of organogenesis produced fetal structural abnormalities. The flunisolide dose in rats and rabbits was approximately 3 and 1 times the maximum recommended human daily inhalation dose (MRHDID), respectively.

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

In two separate embryo-fetal developmental studies, pregnant rats and rabbits receiving flunisolide hemihydrate during the period of organogenesis at doses up to approximately 3 and 1 times, respectively, the MRHDID (on a mg/m2 basis at maternal doses of 200 and 40 mg/kg/day, respectively) showed structural abnormalities in their fetuses.

06/23/2017 (SUPPL-15)

Approved Drug Label (PDF)

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

PATIENT INFORMATION

The most common side effects with AEROSPAN Inhalation Aerosol include:

Addition of the following:

nausea