Topicort

None None ( 4 )

• Effect on Endocrine System:
• Topicort ® Topical Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment.
• ( 5.1 ) Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids.
• ( 5.1 ) Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.
• ( 5.1 ) Modify use if HPA axis suppression develops.
• ( 5.1 ) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression.
• ( 5.1 ) Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids.
• Safety and effectiveness have not been established in pediatric patients and use in pediatric patients is not recommended.
• ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions:
• Topical corticosteroid products may increase the risk of cataracts and glaucoma.
• If visual symptoms occur, consider referral to an ophthalmologist.
• ( 5.3 ).
• Flammability: Topicort Topical Spray is flammable; keep away from heat or flame.
• ( 5.6 )
• 5.1 Effect on Endocrine System Topicort Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
• Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency.
• This may occur during treatment or upon withdrawal of the topical corticosteroid.
• In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10 to15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort Topical Spray twice a day for 28 days [see Clinical Pharmacology (12.2) ] .
• Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.
• Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.
• An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
• If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
• Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
• Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
• Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
• Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
• 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) ] .
• 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
• Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.
• Some local adverse reactions may be irreversible.
• 5.3 Ophthalmic Adverse Reactions 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 .
• 5.4 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation.
• Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
• 5.5 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent.
• If the infection persists, Topicort Topical Spray should be discontinued until the infection has been adequately treated.
• 5.6 Flammability Topicort Topical Spray is flammable; keep away from heat or flame.

• 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.
• IN SPECIFIC POPULATIONS
• 8.1 Pregnancy 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 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) ].
• 8.4 Pediatric Use 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 ≥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 ≤ 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) ] .
• Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than
• adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.
• They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.
• Adverse reactions including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
• HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
• Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
• Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
• 8.5 Geriatric Use Clinical studies of Topicort Topical Spray did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
• Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
• In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Topicort Topical Spray can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ] .