OLUX Foam contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11- hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β)-, with the empirical formula C₂₅H₃₂CIFO₅, a molecular weight of 466.97. The following is the chemical structure:

clobetasol propionate

Clobetasol propionate is a white or almost white, odorless, crystalline powder and is insoluble in water.

OLUX® (clobetasol propionate) Foam, 0.05%, contains 0.5 mg clobetasol propionate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Last updated on RxList: 5/23/2008

OLUX Foam is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of OLUX Foam therapy (See ADVERSE REACTIONS). Use in children under 12 years of age is not recommended.

Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

OLUX Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of OLUX Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying OLUX Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

OLUX Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended. Unless directed by a physician, OLUX Foam should not be used with occlusive dressings.

Instructions for applying OLUX Foam

Apply OLUX Foam twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. OLUX Foam should not be applied to the groin, armpits, or other skin fold areas.

To use OLUX Foam:

Before applying OLUX Foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

Turn the can upside down.

Push the button to squirt a small amount of OLUX Foam into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 ½ capfuls, about the size of a golf ball.

Do not squirt OLUX Foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin. If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

If the can seems warm or the foam seems runny, run the can under cold water.

Using your fingertips, gently massage OLUX Foam into the affected areas until the foam disappears.

If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

Repeat the process until the affected areas are treated.

Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

Wash your hands after applying OLUX Foam. Throw away any of the unused medicine that you squirted out of the can.

OLUX Foam is supplied in 100 g (NDC 63032-031-00) and 50 g (NDC 63032- 031-50) aluminum cans.

Store at controlled room temperature 68-77°F (20-25°C).

WARNING

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Manufactured for : Connetics Corporation, Palo Alto, CA 94304, USA. For additional information: 1-888-500-DERM or visit, www.olux.com. VersaFoam-HF is a trademark, and the V logo, the interlocking C design, OLUX and Connetics are registered trademarks, of Connetics Corporation. January 2006. FDA revision date: 7/11/2006

Last updated on RxList: 5/23/2008

In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of OLUX Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with OLUX Foam. (See Table 3 below.)

Table 3: Subjects with reversible HPA axis suppression at any time during treatment

Dermatosis	OLUX Foam
Psoriasis	1 of 9
Atopic Dermatitis*	4 of 4
*OLUX Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of OLUX Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.

Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients (see PRECAUTIONS).

In a controlled clinical trial (188 subjects) with OLUX Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the OLUX Foam treated subjects. In two controlled clinical trials (360 subjects) with OLUX Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the OLUX Foam treated subjects included application site burning (10%), application site dryness ( < 1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as OLUX Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.

No information provided.

Last updated on RxList: 5/23/2008

No information provided.

General: Clobetasol propionate is a super-potent topical corticosteroid that has been shown to suppress the adrenals at 7.0 g of OLUX Foam per day. Lesser amounts of OLUX Foam were not studied. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which augment systemic absorption include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression. If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. See PRECAUTIONS-Pediatric Use.

If irritation develops, OLUX Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than by noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of OLUX Foam should be discontinued until the infection has been adequately controlled.

Laboratory Tests: The following tests may be helpful in evaluating patients for adrenal suppression:

ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

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.

Pregnancy: Teratogenic Effects: Pregnancy Category C: 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 by the topical route; 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 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 based on body surface area comparisons. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. OLUX Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: 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 Foam is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of OLUX Foam in pediatric patients have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of adrenal suppression and Cushing's syndrome when they are treated with topical corticosteroids. Pediatric patients are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Adrenal 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, headaches, and bilateral papilledema.

Geriatric Use: Clinical studies of OLUX Foam did not include sufficient numbers of subjects aged 65 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.

Last updated on RxList: 5/23/2008

Topically applied OLUX Foam can be absorbed in sufficient amounts to produce systemic effects. See PRECAUTIONS.

OLUX Foam is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

Last updated on RxList: 5/23/2008

Like other topical corticosteroids, clobetasol propionate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

Pharmacokinetics

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Due to the fact that circulating levels are well below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

A well-controlled clinical study evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for 2 weeks with one of four treatments: OLUX Foam, Vehicle foam, a commercially available clobetasol propionate solution (Temovate® Scalp Application), or Vehicle solution. The efficacy of OLUX Foam in treating scalp psoriasis at the end of the 2 weeks' treatment was superior to that of Vehicle (foam and solution), and was comparable to that of Temovate Scalp Application. See Table 1 below.

Table 1: Efficacy results from a controlled clinical trial in scalp psoriasis

	OLUX Foam n (%)	Vehicle Foam n (%)
Total number of subjects	62	31
Subjects with Treatment Success*	39 (63)	1 (3)
Subjects with Parameter Clear at End point (Scalp Psoriasis)
Scaling-Clear at End point	42 (68)	3 (10)
Erythema-Clear at End point	27 (44)	2 (6)
Plaque Thickness-Clear at End point	41 (66)	3 (10)
*Defined as a composite of an Investigator's Global Assessment of “completely clear” or “almost clear,” a plaque thickness score of 0, an erythema score of 0 or 1, and a scaling score of 0 or 1 at Endpoint, scored on a severity scale of 0-4.

Another well-controlled clinical study evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean Body Surface Area at baseline was 6.7% with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with OLUX Foam or Vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of OLUX Foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of Vehicle foam. See Table 2 below.

Table 2: Efficacy results from a controlled clinical trial in non-scalp psoriasis Plaque Thickness - Clear at Endpoint 41 (66) 3 (10)

	OLUX Foam n (%)	Vehicle Foam n (%)
Total number of subjects	139	140
Subjects with Treatment Success*	39 (28)	4 (3)
Physician's Static Global Assessment-Clear or	94 (68)	30 (21)
Almost Clear at Endpoint
Scaling-Clear or Almost Clear at Endpoint	101 (73)	42 (30)
Erythema-Clear or Almost Clear at Endpoint	88 (63)	35 (25)
Plaque Thickness-Clear at Endpoint	44 (32)	5 (4)
*Defined as a composite of a Physician's Static Global Assessment score of 0 or 1, scaling score of 0 or 1, an erythema score of 0 or 1 and a plaque thickness score of 0, based on a severity scale of 0-5 at Endpoint.

Last updated on RxList: 5/23/2008

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.

Last updated on RxList: 5/23/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CLOBETASOL FOAM - TOPICAL

(kloh-BAY-tuh-sall)

COMMON BRAND NAME(S): Olux

USES: Clobetasol is used to treat certain scalp and skin conditions (e.g., psoriasis, dermatitis, rash). Clobetasol reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.

HOW TO USE: Apply this medication to the scalp, usually twice daily in the morning and evening or as directed by your doctor.

Learn all preparation and usage instructions in the product package, and ask your doctor or pharmacist if you have questions about any of the information.

Use this medication only on the skin. However, do not use it on the face, groin or underarms unless directed to do so by your doctor.

Wash and dry your hands before applying. Apply the prescribed amount of medication to the affected area and gently rub in. Do not bandage, wrap or cover the area unless directed to do so by your doctor.

After applying the medication, wash your hands, unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.

Use this medication exactly as prescribed. Do not increase your dose, take it more frequently, or use it for longer than 2 weeks in a row. Do not apply more than one 50-gram can in a given week unless directed by your doctor. Doing so could increase your risk of side effects.

Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Burning, stinging, itching, irritation, dryness, or redness may occur when this medication is first applied to the scalp/skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks (striae), skin thinning/discoloration, excessive hair growth, acne, hair bumps (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (e.g., hydrocortisone, dexamethasone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, other skin/scalp conditions (e.g., rosacea, perioral dermatitis), immune system problems.

Do not use if there is an infection or sore in the area to be treated.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this drug for an extended period of time, especially if they also have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst or urination, unusual weakness, unusual weight loss, dizziness.

Consult your doctor or pharmacist for more details, and inform them that you use or have used this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professional (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone), other topical corticosteroids (e.g., hydrocortisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood test) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for more than 2 weeks, apply it over large areas of the body, or bandage/wrap the treated areas. Consult your doctor for more details.

Inform all your doctors you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from heat and open flame. Do not puncture the can. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.