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.

BACTROBAN (NDA-050703)

(MUPIROCIN CALCIUM)

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

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05/08/2017 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Severe Allergic Reactions

(Additions and/or revisions are underlined)

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of BACTROBAN, including BACTROBAN nasal ointment.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following adverse reactions are discussed in more detail in other sections of the labeling:

Severe Allergic Reactions

8 Use in Specific Populations

8.1 Pregnancy

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

Risk Summary

There are insufficient human data to establish whether there is a drug-associated risk with BACTROBAN nasal ointment in pregnant women. Mupirocin absorption was negligible following repeated intranasal administration of BACTROBAN nasal ointment, but the dose regimen used in this study did not mimic recommended clinical use. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (65 and 32 times the human intranasal dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data

Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 65 and 130 times, respectively, the human intranasal dose (approximately 20 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 32 times the human intranasal dose based on calculations of dose divided by the entire body surface area.

Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 37 times the human intranasal dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 18 times the human intranasal dose.

8.2 Lactation

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

Risk Summary

It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of mupirocin in humans following intranasal administration of BACTROBAN nasal ointment.

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

8.4 Pediatric Use

(Additions and/or revisions are underlined)

The safety and effectiveness of BACTROBAN nasal ointment in children younger than 12 years have not been established.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to administer BACTROBAN nasal ointment as follows:

Use BACTROBAN nasal ointment only as directed by the healthcare provider. Avoid contact of BACTROBAN nasal ointment with the eyes. If BACTROBAN nasal ointment gets in or near the eyes, rinse thoroughly with water.
Wash your hands before and after applying BACTROBAN nasal ointment.
Apply approximately one-half of the BACTROBAN nasal ointment from the single-use tube directly into 1 nostril and the other half into the other nostril.
Report to the healthcare provider any signs of local adverse reactions. BACTROBAN nasal ointment should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.
Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur.

PATIENT INFORMATION

(Additions and/or revisions are underlined)

What is BACTROBAN nasal ointment?

BACTROBAN nasal ointment is a prescription medicine used to reduce the amount of methicillin-resistant Staphylococcus aureus (MRSA) bacteria in your nose.

Who should not use BACTROBAN nasal ointment?

Do not use BACTROBAN nasal ointment if:

you are allergic to mupirocin or any of the ingredients in BACTROBAN nasal ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in BACTROBAN nasal ointment.

What should I tell my healthcare provider before using BACTROBAN nasal ointment?

Before using BACTROBAN nasal ointment, tell your healthcare provider about all of your medical conditions including if you:

are breastfeeding or plan to breastfeed. It is not known if BACTROBAN nasal ointment passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN nasal ointment while breastfeeding.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

How should I use BACTROBAN nasal ointment?

BACTROBAN nasal ointment is for use in the nose (intranasal). Do not get BACTROBAN in your eyes or mouth.
Apply approximately one-half of the BACTROBAN nasal ointment from a single-use tube to the inside surface at the front of each nostril 2 times a day for 5 days.

What are the possible side effects of BACTROBAN nasal ointment? BACTROBAN nasal ointment may cause serious side effects, including:

severe allergic reactions. Stop using BACTROBAN nasal ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:

hives
trouble breathing or wheezing
swelling of your face, lips, mouth, or tongue
dizziness, fast heartbeat, or pounding in your chest
a rash over your whole body

eye irritation. Do not get BACTROBAN nasal ointment in your eyes. If BACTROBAN nasal ointment gets in your eyes, rinse your eyes well with water.
irritation in the area BACTROBAN nasal ointment is used. Stop using BACTROBAN nasal ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using BACTROBAN nasal ointment.
a type of diarrhea called clostridium difficile-associated diarrhea (CDAD). CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using BACTROBAN nasal ointment.

How should I store BACTROBAN nasal ointment?

Do not refrigerate BACTROBAN nasal ointment.
Keep BACTROBAN nasal ointment and all medicines out of the reach of children.