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.

XHANCE (NDA-209022)

(FLUTICASONE PROPIONATE)

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

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03/15/2024 (SUPPL-19)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Glaucoma and Cataracts

Additions and/or revisions underlined:

Nasal and inhaled corticosteroids, including fluticasone propionate, may result in the development of glaucoma and/or cataracts. In placebo-controlled clinical trials of 16 weeks duration, cataracts were reported in 4 (1.2%) patients treated with XHANCE, compared with 3 (1.9%) patients treated with placebo. Among these patients, 2 patients treated with XHANCE reported subcapsular cataracts compared with none treated with placebo.

Eleven patients (1.2%) in uncontrolled, open-label trials of 3 to 12 months duration developed new or worsening cataracts, of which none were subcapsular. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts.

Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.

5.3 Hypersensitivity Reactions Including Anaphylaxis

Additions and/or revisions underlined:

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. XHANCE is contraindicated in patients with known hypersensitivity to fluticasone propionate or any of the ingredients of XHANCE. Discontinue XHANCE if such reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) occur [see Contraindications (4) and Adverse Reactions (6.1)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postapproval use of XHANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: central serous chorioretinopathy

Respiratory, thoracic, and mediastinal disorders: dysphonia, nasal discomfort, and nasal dryness

Skin and subcutaneous tissue disorders: pruritus, rash

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Clinical trials of XHANCE for Chronic Rhinosinusitis with Nasal Polyps did not include sufficient numbers of patients aged 65 years and older to determine whether they responded differently than younger patients. Other reported clinical experience with fluticasone administered nasally or orally inhaled has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

There were 82 patients 65 years of age and older in clinical trials for Chronic Rhinosinusitis without Nasal Polyps [see Clinical Studies (14)]. Of the total number of XHANCE-treated patients in these studies, 51 (14%) were 65 years of age and older. No overall differences in safety and effectiveness of XHANCE have been observed between patients 65 years of age and older and younger adult patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Inform patients that they should use XHANCE on a regular basis as directed. XHANCE, like other corticosteroids, does not have an immediate effect on CRSsNP or CRSwNP or symptoms. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for up to 16 weeks or longer. Maximum benefit may not be reached for a period of months. Patients should not increase the prescribed dosage, but should contact their healthcare providers if symptoms do not improve or if the condition worsens.

…

To actuate the device, patients should be advised to push the bottle up while continuing to blow forcefully into the mouthpiece. Within the device is a valve that prevents the release of breath until the bottle is pushed.

Pushing the bottle also actuates the spray pump, releasing a metered dose of aerosolized medication while simultaneously allowing a “burst” of exhaled breath to pass through the device. This helps deliver the medication deep into the patient’s nose.

…

PATIENT INFORMATION

Additions and/or revisions underlined:

What is XHANCE?

XHANCE is a prescription medicine used to treat:

chronic rhinosinusitis with nasal polyps in adults.
chronic rhinosinusitis without nasal polyps in adults.

It is not known if XHANCE is safe and effective in children.

…

What are the possible side effects of XHANCE?

XHANCE may cause serious side effects, including:

…

Reduced adrenal function (adrenal insufficiency). Reduced adrenal function happens when your adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking medicine containing a steroid inhaled into the lungs or for use in the nose. Adrenal insufficiency can also happen when nasal corticosteroids, such as XHANCE, are used at a dose higher than the usual dose or in people who are likely to have adrenal insufficiency at the usual dose. This may be more likely to happen after surgery or during periods of stress. Symptoms of reduced adrenal function may include:

…

The most common side effects of XHANCE in adults with chronic rhinosinusitis with nasal polyps include:

…

The most common side effects of XHANCE in adults with chronic rhinosinusitis without nasal polyps include:

nose bleeds
headache

pain or swelling of your nose or throat (nasopharyngitis)

…

01/20/2023 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Local Nasal Adverse Reactions

Subsection title revised

5.4 Immunosuppression and Risk of Infection

Subsection title revised

Additions and revisions underlined:

Persons who are using drugs that suppress the immune system, such as corticosteroids, including XHANCE, are more susceptible to infections than healthy individuals and may experience a worsening of existing infections.

5.5 Hypercorticism and Adrenal Suppression

Subsection title revised

6 Adverse Reactions

Additions and revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Local Nasal Adverse Reactions: [see Warnings and Precautions (5.1)]
Cataracts and Glaucoma [see Warnings and Precautions (5.2)]
Hypersensitivity Reactions including Anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.3)]
Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4)]
Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.5)]
Reduction in Bone Mineral Density [see Warnings and Precautions (5.7)]
Effect on Growth [see Warnings and Precautions (5.8)]

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Local Nasal Adverse Reactions

Inform patients that treatment with XHANCE may lead to adverse reactions, which include epistaxis, nasal erosions, and nasal ulceration. Candida infection may also occur with treatment with XHANCE.

Immunosuppression and Risk of Infections

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles, and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

PATIENT INFORMATION

Additions and revisions underlined:

What is XHANCE?

XHANCE is a prescription medicine used to treat chronic rhinosinusitis with nasal polyps in adults.

01/20/2023 (SUPPL-17)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during postapproval use of XHANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory, thoracic, and mediastinal disorders: dysphonia, nasal discomfort, and nasal dryness

Skin and subcutaneous tissue disorders: pruritus, rash