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.

ORTIKOS (NDA-211929)

(BUDESONIDE)

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

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06/05/2024 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypercorticism and Adrenal Axis Suppression

Additions and/or revisions underlined:

…

Pediatric patients with Crohn’s disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression than adults with Crohn’s disease [see Use in Specific Populations (8.4), Clinical Pharmacology (12.2)]. Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression.

…

Corticosteroids, including ORTIKOS, 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

Newly added information:

Corticosteroids, including ORTIKOS, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:

Reduce resistance to new infections
Exacerbate existing infections
Increase the risk of disseminated infections
Increase the risk of reactivation or exacerbation of latent infections
Mask some signs of infection

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor patients for the development of infection and consider discontinuation of ORTIKOS if the patient develops an infection while on treatment.

Tuberculosis

If ORTIKOS is used in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged ORTIKOS therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections

Varicella and measles can have a serious or even fatal course in nonimmune patients taking corticosteroids, including ORTIKOS. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:

If an ORTIKOS-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered.

If an ORTIKOS-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including ORTIKOS. Reactivation can also occur infrequently in corticosteroid- treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with ORTIKOS. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections

Corticosteroids, including ORTIKOS, may exacerbate systemic fungal infections; therefore, avoid ORTIKOS use in the presence of such infections. For patients on chronic ORTIKOS therapy who develop systemic fungal infections, ORTIKOS withdrawal or dosage reduction is recommended.

Amebiasis

Corticosteroids, including ORTIKOS, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating ORTIKOS in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation

Avoid ORITKOS in patients with known or suspected Strongyloides (threadworm) infection. Corticosteroid- induced immunosuppression may lead to Strongyloides superinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria

Avoid corticosteroids, including ORTIKOS, in patients with cerebral malaria.

Ocular Herpes Simplex

Avoid corticosteroids, including ORTIKOS, in patients with active ocular herpes simplex.

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 and, if exposed, to consult. Advise patients inform their healthcare provider immediately. Inform patients that if they are at increased risk of developing a variety of infections; including worsening of existing tuberculosis, fungal, bacterial, viral exposed to varicella or parasitic infections measles or ocular herpes simplex and to contact their healthcare provider if they if they develop any symptoms of 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:

ORTIKOSTH (or-TEE-kos) (budesonide) delayed-release capsules, for oral use

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

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

have malaria of the brain (cerebral malaria).

…

ORTIKOS may cause serious side effects, including:

Decreased ability of your body to fight infections (immunosuppression) and increased risk of Infection. Corticosteroid medicines, including ORTIKOS, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including ORTIKOS 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 provider should check you closely for signs and symptoms of an infection while taking ORTIKOS. Tell your healthcare provider right away about signs or symptoms of a new or worsening infection while taking ORTIKOS, 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 ORTIKOS. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking ORTIKOS.
Chicken pox and measles: People taking corticosteroid medicines, including ORTIKOS, who have not had chicken pox (varicella) 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 ORTIKOS. Your healthcare provider will test you for HBV before you start taking ORTIKOS.
Amebiasis: Inactive (latent) amebiasis may become an active infection while taking ORTIKOS. Your healthcare provider should check you for amebiasis before you start taking ORTIKOS if you have spent time in the tropics or have unexplained diarrhea.

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