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.

TOPICORT (NDA-204141)

(DESOXIMETASONE)

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

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10/07/2021 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Effect on Endocrine System

Additions underlined

…

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression (the safety and effectiveness of Topicort Topical Spray have not been established in pediatric patients) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

5.3 Ophthalmic Adverse Reactions

New subsection added

Use of topical corticosteroids, including Topicort Topical Spray, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products [see Adverse Reactions (6.2)]. Avoid contact of Topicort Topical Spray with eyes. Topicort Topical Spray may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

6 Adverse Reactions

6.2 Postmarketing Experience

New subsection added

Because adverse 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.

Postmarketing reports for local adverse reactions to topical corticosteroids included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.

Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported during use of topical corticosteroids.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined

The safety and effectiveness of Topicort Topical Spray have not been established in pediatric patients for the treatment of plaque psoriasis. Topicort Topical Spray is not recommended for use in patients less than 18 years of age due to the high incidence of HPA axis suppression observed [see Warnings and Precautions (5.1)].

Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression

The HPA axis suppression potential of Topicort Topical Spray was assessed in an open-label, sequential cohort, safety trial in 129 subjects 2 years to less than 18 years of age with moderate to severe plaque psoriasis defined as a Physician Global Assessment (PGA) score of greater than or equal to 3 with involvement of at least 10% of their body surface area (excluding the face and scalp). In total, 100 pediatric subjects were evaluated for HPA axis function via cosyntropin stimulation testing at baseline and following 4 weeks of twice daily application of Topicort Topical Spray. Overall, 36% of pediatric subjects 2 years to less than 18 years of age demonstrated HPA axis suppression defined as a serum cortisol level less than or equal to 18 mcg/dL 30-minutes post cosyntropin stimulation. The proportion of subjects demonstrating HPA axis suppression was 35.0% in Cohort 1 (12 years to less than 18 years of age) and 43.3% in Cohort 2 (6 years to less than 12 years of age). Trial enrollment in the youngest cohort (2 years to less than 6 years of age) was discontinued early due to high incidence of HPA axis suppression observed in the two oldest cohorts (6 years to less than 18 years of age) [see Clinical Pharmacology (12.2)].

…

8.1 Pregnancy

PLLR conversion

Risk Summary

There are no available data on desoximetasone use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids, including Topicort Topical Spray, may be associated with an increased risk of low birthweight infants (see Data). Advise pregnant woman that Topicort Topical Spray may increase the potential risk of low birth weight infants and to use Topicort Topical Spray on the smallest area of skin and for the shortest duration possible.

Desoximetasone has been shown to cause malformations and be embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort Topical Spray based on a body surface area comparison.

The background risk of major birth defects and miscarriage for 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.

Data

Human Data

Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of high to super-high potency topical corticosteroids exceeded 300g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.

8.2 Lactation

PLLR conversion

Risk Summary

There is no information on the presence of topically administered desoximetasone in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Topicort Topical Spray and any potential adverse effects on the breastfed infant from Topicort Topical Spray or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Topicort Topical Spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Topicort Topical Spray directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

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

PATIENT COUNSELING INFORMATION

Additions underlined

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Inform patients of the following:

Use this medication as directed by the physician. Do not use this medication for any disorder other than that for which it was prescribed.
Topicort Topical Spray is for external use only.
Avoid contact with eyes and use on the face, axilla or groin.
To minimize the risk of adverse reactions:
- do not bandage or otherwise cover or wrap the treated skin so as to be occlusive.
- discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
- do not use other corticosteroid-containing products with Topicort Topical Spray without first consulting with the physician.

Advise patients that Topicort Topical Spray, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. [see Warnings and Precautions (5.1)].
Advise women to use Topicort Topical Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding woman not to apply Topicort Topical Spray directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.1 and 8.2)].
Report any signs of local or systemic adverse reactions including any visual symptoms to the physician.
This medication is flammable; avoid heat, flame, or smoking when applying this product.
Discard this product 30 days after dispensed by pharmacist.

PATIENT INFORMATION

Extensive changes, please refer to label.