Included as part of the PRECAUTIONS section.
Effects on Endocrine System
Olux-E (clobetasol propionate foam) Foam has been shown to suppress the HPA axis.
Systemic absorption of Olux-E (clobetasol propionate foam) has caused reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency.
This may occur during treatment or upon withdrawal of the topical corticosteroid.
Use of Olux-E (clobetasol propionate foam) Foam for longer than 2 weeks may suppress the immune system. [see
In a study including 37 subjects ages 12 and older with at least 30% body surface
area (BSA), adrenal suppression was identified in 6 out of 37 subjects (16.2%)
after two weeks of treatment with Olux-E. [see CLINICAL PHARMACOLOGY]
Because of the potential for systemic absorption, use of Olux-E (clobetasol propionate foam) 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 more potent steroids, use over large surface areas, use over
prolonged periods, use under occlusion, use on an altered skin barrier, and
use in patients with liver failure.
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 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 equivalent
doses because of their larger skin surface to body mass ratios. [see Use
in Specific Populations]
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.
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
If irritation develops, treatment with Olux-E (clobetasol propionate foam) Foam should be discontinued and
appropriate therapy instituted.
Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial
agent. If the infection persists, Olux-E (clobetasol propionate foam) Foam should be discontinued until the
infection has been adequately treated.
The propellant in Olux-E (clobetasol propionate foam) Foam is flammable. Avoid fire, flame or smoking during
and immediately following application. Do not puncture and/or incinerate the
containers. Do not expose containers to heat and/or store at temperatures above
Patient Counseling Information
[See FDA-Approved Patient Labeling]
Patients using topical corticosteroids should receive the following information
- This medication is to be used as directed by the physician. It is for external
use only. Unless directed by the prescriber, it should not be used on the
face, or in skin-fold areas, such as the underarms or groin. Avoid contact
with the eyes or other mucous membranes. Wash hands after use.
- This medication should not be used for any disorder other than that for
which it was prescribed.
- The treated skin area should not be bandaged, wrapped, or otherwise covered
so as to be occlusive unless directed by the physician.
- Patients should report any signs of local or systemic adverse reactions
to the physician.
- Patients should inform their physicians that they are using Olux-E (clobetasol propionate foam) Foam
if surgery is contemplated.
- As with other corticosteroids, therapy should be discontinued when control
is achieved. If no improvement is seen within 2 weeks, contact the physician.
- Patients should not use more than 50 grams per week of Olux-E (clobetasol propionate foam) Foam, or an
amount greater than 21 capfuls per week. [see DOSAGE AND ADMINISTRATION]
- This medication is flammable; avoid heat, flame or smoking when applying
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic
potential of Olux-E Foam or clobetasol propionate. In a 90-day repeat-dose toxicity
study in rats, topical administration of Olux-E (clobetasol propionate foam) Foam at dose concentrations
from 0.001 – 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol propionate resulted
in a toxicity profile consistent with long term exposure to corticosteroids
including adrenal atrophy, histopathological changes in several organs systems
indicative of severe immune suppression and opportunistic fungal and bacterial
infections. A NOAEL could not be determined in this study. Although the clinical
relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related
immune suppression may increase the risk of infection and possibly the risk
Clobetasol propionate was non-mutagenic in four different test systems: the
Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion
assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus
test, a positive finding was observed at 24 hours, but not at 48 hours, following
oral administration at a dose of 2000 mg/kg.
Studies in the rat following subcutaneous administration of clobetasol propionate
at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited
an increase in the number of resorbed embryos and a decrease in the number of
living fetuses at the highest dose.
Use In Specific Populations
Teratogenic Effects, Pregnancy Category C
There are no adequate and well-controlled
studies of the teratogenic potential of clobetasol propionate in pregnant women.
Olux-E (clobetasol propionate foam) Foam should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. Some corticosteroids
have been shown to be teratogenic after dermal application to laboratory animals.
Clobetasol propionate has not been tested for teratogenicity when applied topically;
however, it is absorbed percutaneously, and when administered subcutaneously,
it was a significant teratogen in both the rabbit and the mouse. Clobetasol
propionate has greater teratogenic potential than steroids that are less potent.
Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity
at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested
down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively,
the human topical dose of Olux-E (clobetasol propionate foam) Foam based on body surface area comparisons.
Abnormalities seen included cleft palate and skeletal abnormalities.
In rabbits, clobetasol propionate was teratogenic at doses of 0.003 and 0.01
mg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the
human topical dose of Olux-E (clobetasol propionate foam) Foam based on body surface area comparisons. Abnormalities
seen included cleft palate, cranioschisis, and other skeletal abnormalities.
Systemically administered corticosteroids appear in human milk and could suppress
growth, interfere with endogenous corticosteroid production, or cause other
untoward effects. It is not known whether topical administration of corticosteroids
could result in sufficient systemic absorption to produce detectable quantities
in breast milk. Because many drugs are excreted in human milk, caution should
be exercised when Olux-E (clobetasol propionate foam) Foam is administered to a nursing woman.
If used during lactation, Olux-E (clobetasol propionate foam) Foam should not be applied on the chest to
avoid accidental ingestion by the infant.
Use in pediatric patients under 12 years of age is not recommended because
of the risk of HPA axis suppression.
After two weeks of twice daily treatment with Olux-E (clobetasol propionate foam) Foam, 7 of 15 patients
(47%) aged 6 to 11 years of age demonstrated HPA axis suppression. The laboratory
suppression was transient; in all subjects serum cortisol levels returned to
normal when tested 4 weeks post treatment.
In 92 patients from 12 to 17 years of age, safety was similar to that observed
in the adult population. Based on these data, no adjustment of dosage of Olux-E (clobetasol propionate foam)
Foam in adolescent patients 12 to 17 years of age is warranted.
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 also
at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.
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 an absence of response to ACTH stimulation. Manifestations
of intracranial hypertension include bulging fontanelles (in infants), headaches,
and bilateral papilledema. Administration of topical corticosteroids to children
should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development
Adverse effects including striae have been reported with inappropriate use
of topical corticosteroids in infants and children.
A limited number of patients at or above 65 years of age have been treated
with Olux-E (clobetasol propionate foam) Foam (n = 58) in US clinical trials. While the number of patients
is too small to permit separate analysis of efficacy and safety, the adverse
reactions reported in this population were similar to those reported by younger
patients. Based on available data, no adjustment of dosage of Olux-E (clobetasol propionate foam) Foam in
geriatric patients is warranted.