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.

ENTOCORT EC (NDA-021324)

(BUDESONIDE)

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

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06/05/2024 (SUPPL-27)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypercorticism and Adrenal Axis Suppression

Additions and/or revisions underlined:

…

Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression during treatment with ENTOCORT EC.

…

Corticosteroids, including ENTOCORT EC, can reduce the response of the hypothalamus- pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended.

5.3 Immunosuppression and Increased Risk of Infection

Subsection title revised

Extensive changes; please refer to label for complete information

5.4 Kaposi’s Sarcoma

Newly added subsection:

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

6 Adverse Reactions

Additions and/or revisions underlined:

Immunosuppression and increased risk of infection [see Warnings and Precautions (5.3)]
Kaposi’s sarcoma [see Warnings and Precautions (5.4)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Immunosuppression and Increased Risk of Infection

Advise patients to avoid exposure to people with varicella (chicken pox) or measles. Advise patients inform their healthcare provider if they are exposed to varicella or measles or if they develop a new or worsening infection [see Warnings and Precautions (5.3)].

Kaposi’s Sarcoma

Advise patients that Kaposi’s sarcoma has been reported in patients receiving corticosteroids for chronic conditions and to inform their healthcare provider if they experience signs or symptoms of Kaposi’s sarcoma [see Warnings and Precautions (5.4)].

PATIENT INFORMATION

Additions and/or revisions underlined:

Before you take ENTOCORT EC tell your healthcare provider if you have any other medical conditions including if you:

have an infection, including fungal and threadworm (Strongyloides) infections.
…

have malaria of the brain (cerebral malaria).

…

ENTOCORT EC may cause serious side effects, including:

…

Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including ENTOCORT EC, lower the ability of your immune system to fight infections and increase the risk of infections caused by virus, bacteria, fungi, protozoan, or certain parasites. Corticosteroid medicines including ENTOCORT EC can also:

make current infections worse
increase the risk of infections spreading (disseminated)
increase the risk of making infections active again or making infections worse that have not been active (latent)
hide (mask) some signs of infection

These infections can be mild, but can be severe and lead to death. Your healthcare provide should check you closely for signs and symptoms of an infection while taking ENTOCORT EC. Tell your healthcare provider right awayabout any signs or symptoms of a new or worsening infection while taking ENTOCORT EC, including flu-like symptoms such as:.

fever
cough
chills
pain
stomach area (abdominal) pain
feeling tired
aches
nausea and vomiting
diarrhea

Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking ENTORCORT EC your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking ENTOCORT EC.
Chicken pox and measles: People taking corticosteroid medicines, including ENTOCORT EC, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
Hepatitis B Virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking ENTOCORT EC. Your healthcare provider will test you for HBV before you start taking ENTOCORT EC.
Amebiasis: Inactive (latent) amebiasis before you start taking ENTOCORT EC. Your healthcare provider should check you for amebiasis before you start taking ENTOCORT EC in people who have spent time in the tropcs or have unexplained diarrhea.

Kaposi’s Sarcoma. Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment with ENTOCORT EC, including:of long-lasting (chronic) conditions.

07/15/2020 (SUPPL-23)

Approved Drug Label (PDF)

Other

(Entocort EC extended-release capsules revised to read Entocort EC delayed-release capsules throughout labeling)

01/18/2019 (SUPPL-18)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

Risk Summary

The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

8.2 Lactation

(Additions and/or revisions are underlined)

Data

The maximum budesonide plasma concentration following a 9 mg daily dose (in both single- and repeated-dose pharmacokinetic studies) of oral budesonide is approximately 2.15 to 4.31 ng/mL which is up to 10 times higher than the 0.43 to 0.86 ng/mL for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation study. Assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of ENTOCORT EC, budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Pregnancy

Advise female patients that ENTOCORT EC may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy.

Administration

Swallow ENTOCORT EC extended-release capsules whole. Do not chew or crush.
For patients unable to swallow an intact capsule, ENTOCORT EC extended-release capsules can be opened and administered as follows:

Place one tablespoonful of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
Open the capsule(s).
Carefully empty all the granules inside the capsule(s) on the applesauce.
Mix the granules with the applesauce.
Consume the entire contents within 30 minutes of mixing. Do not chew or crush the granules. Do not save the applesauce and granules for future use.
Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to ensure complete swallowing of the granules.

PATIENT INFORMATION

(Extensive changes; please refer to labeling)

10/17/2017 (SUPPL-16)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

Data

Animal Data

Budesonide was teratogenic and embryolethal in rabbits and rats.

In an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis from gestation days 6-15 there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on a body surface area basis). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses up to approximately 25mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis)…

…In addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures 0.02 times the MRHD (on a mg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity.