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In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of OLUX (clobetasol propionate) 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 (clobetasol propionate) Foam. (See Table 3 below.)
Table 3: Subjects with reversible HPA axis suppression at any time during treatment
|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 (clobetasol propionate) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the OLUX (clobetasol propionate) Foam treated subjects. In two controlled clinical trials (360 subjects) with OLUX (clobetasol propionate) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the OLUX (clobetasol propionate) 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 (clobetasol propionate) 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.
Read the entire FDA prescribing information for Olux (Clobetasol Propionate)Read More »
Olux Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Burning or stinging at the application site
- Burning sensation of the skin
- dry skin
- flushing or redness of the skin
- itching, scaling, severe redness, soreness, or swelling of the skin
- skin irritation
- skin rash, encrusted, scaly and oozing
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
- Burning, itching, and pain in hairy areas, or pus at the root of the hair
- hair loss
- redness and scaling around the mouth
- thinning of the hair
- thinning, weakness, or wasting away of the skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- sore throat
- Body aches or pain
- changes in skin coloring
- congestion or cough
- dryness or soreness of the throat
- raised, dark red, wart-like spots on the skin, especially when used on the face
- skin discomfort
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble swallowing
- unusual tiredness or weakness
- voice changes
- Acne or pimples
- burning and itching of the skin with pinhead-sized red blisters
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- reddish purple lines on the arms, face, legs, trunk, or groin
- softening of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What are some things I need to know or do while I take Olux?
- Tell all of your health care providers that you take Olux. This includes your doctors, nurses, pharmacists, and dentists.
- Do not use to treat diaper rash.
- Do not use this medicine to treat acne, rosacea, or a rash around the mouth.
- Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
- Talk with your doctor before you use other drugs or products on your skin.
- Do not put on cuts, scrapes, or damaged skin.
- Do not use longer than you have been told by the doctor.
- This medicine may cause harm if swallowed. If Olux is swallowed, call a doctor or poison control center right away.
- This medicine may catch on fire. Do not use near an open flame or while smoking.
- Use with care in children. Talk with the doctor.
- This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- Some products are not approved for use in children. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Olux) best taken?
Use Olux as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Use as you have been told, even if your signs get better.
- Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
- Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
- Clean affected part before use. Make sure to dry well.
- Put a thin layer on the affected skin and rub in gently.
- Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
- Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
- Turn the can upside down to use. Some foams may start to melt if put into the hand. Check with your pharmacist about how to use the foam.
- Put foam on affected part and rub in gently.
What do I do if I miss a dose?
- Put on a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not put on 2 doses or extra doses.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Olux?
- Store at room temperature. Do not refrigerate or freeze.
- Protect from heat or open flame.
- Do not puncture.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Indications and Usage for Olux
Olux Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Olux Foam or clobetasol propionate.
In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from 0.001% to 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 no observable adverse effect level (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 for carcinogenesis.
Topical doses of 0% (foam vehicle), 0.001%, 0.01%, and 0.05% clobetasol propionate foam were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in hairless albino mice with concurrent exposure to low-level ultraviolet radiation. Topical treatment with increasing concentrations of clobetasol propionate foam did not have an adverse effect in this study.
The results of this study suggest that topical treatment with Olux Foam would not enhance photocarcinogenesis.
Clobetasol propionate was nonmutagenic in 4 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 2,000 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.
A well-controlled clinical trial evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for 2 weeks with one of 4 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 (Table 2).
|* 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 to 4.|
Total number of subjects
Subjects with treatment success*
Subjects with parameter Clear at endpoint (scalp psoriasis)
Scaling - Clear at endpoint
Erythema - Clear at endpoint
Plaque Thickness - Clear at endpoint
Another well-controlled clinical trial 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 (Table 3).
|* 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 to 5 at endpoint.|
Total number of subjects
Subjects with treatment success*
Physician's Static Global Assessment -Clear or almost clear at endpoint
Scaling - Clear or almost clear at endpoint
Erythema - Clear or almost clear at endpoint
Plaque Thickness - Clear at endpoint