Luxiq Foam contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.

Betamethasone valerate is 9-fluoro11β,17, 21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C₂₇H₃₇FO₆, a molecular weight of 476.58.The following is the chemical structure:

Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether.

Luxiq® (betamethasone valerate) Foam, 0.12%, contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Luxiq is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

Note: For proper dispensing of foam, can must be inverted.

For application to the scalp invert can and dispense a small amount of Luxiq onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Luxiq should not be used with occlusive dressings unless directed by a physician.

Luxiq is supplied in 150 gram (NDC 63032-021-01), 100 gram (NDC 63032-021-00) and 50 gram (NDC 63032-021-50) 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 Stiefel Laboratories, Inc., Coral Gables, FL 33134, USA. For additional information: 1-888-500-DERM or visit www.luxiq.com. FDA Rev date: 7/11/2006

The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows:

Other adverse events which were considered to be possibly, probably, or definitely related to Luxiq occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

No information provided.

No information provided.

General: Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis 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 the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis 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, Luxiq should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than 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 Luxiq should be discontinued until the infection has been adequately controlled.

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

1. This medication is to be used as directed by the physician. 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 scalp 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.
5. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis 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 or the effect on fertility of betamethasone valerate. Betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.

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 in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Therefore, Luxiq 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 Luxiq is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. 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. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Hypothalamic-pituitary-adrenal (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, 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 of children.

Topically applied Luxiq can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS)

Luxiq is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

Like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. 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.

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. 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

The safety and efficacy of Luxiq has been demonstrated in a four-week trial. An adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for four weeks with Luxiq Foam, Placebo foam, a commercially available betamethasone valerate lotion 0.12% (formerly expressed as 0.1% betamethasone), or Placebo lotion. At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Luxiq Foam in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion (see Table below).

Luxiq®
(betamethasone valerate) Foam, 0.12%

Your doctor has prescribed Luxiq (betamethasone valerate) Foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Luxiq works because its active ingredient is betamethasone valerate, 0.12%. Betamethasone belongs to a group of medicines known as topical corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.

Other ingredients in Luxiq include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon propellant (propane and butane).

How to apply Luxiq

Turn the can upside down and dispense a small amount of Luxiq onto a clean saucer or other cool, clean surface. Do not dispense directly onto hands, as foam will begin to melt immediately upon contact with warm skin. How to apply Luxiq

Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. Use sparingly-only enough to cover the affected areas.

Gently massage the foam in until it is absorbed and allow the areas to dry naturally.

When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area.

Wash your hands immediately after applying Luxiq, and discard any unused dispensed medication.

Do not wash or rinse the treated areas immediately after applying Luxiq.

• Do not use this medication for any condition other than the one for which it was prescribed.
• Luxiq is for external use only.
• Keep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately.

WHAT YOU SHOULD KNOWABOUT LUXIQ:

What to do if you miss an application If you forget to apply Luxiq at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. If you miss several doses, tell your doctor at your next appointment.

About side effects

As with all medications, there may be some side effects. The most frequent side effects associated with the use of Luxiq include mild burning, stinging, or itching at the site of application. These side effects typically disappear shortly after application. Let your doctor know if you notice any of the following:

• Any unusual effects that you do not understand.
• Affected areas that do not seem to be healing after several weeks of using the foam.

Important safety notes

• The treated areas should not be bandaged or covered unless directed by your doctor.
• Keep this and all medicines out of the reach of children.
• Store the can at controlled room temperature 68-77°F (20-25°C) and protect it from direct sunlight, as this is a pressurized container.
• Keep away from and do not spray near fire, open flame, or direct heat -this product is flammable. Do not smoke while using or holding the can. Keep the can away from all sources of ignition. Do not pierce or burn the can, and never throw the can in a fire, even if empty. When you have finished your treatment, dispose of the can safely. A completely empty can is recyclable.
• Do not use the foam after the expiration date shown on the bottom of the can.
• Do not give Luxiq to anyone else. Your doctor has prescribed this medicine for your use only.

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.

BETAMETHASONE FOAM - TOPICAL

(bay-tuh-METH-uh-sown)

COMMON BRAND NAME(S): Luxiq

USES: This medication is used to treat a variety of skin conditions of the scalp (e.g., psoriasis, seborrhea). Betamethasone valerate foam belongs to a class of drugs known as corticosteroids. It works by decreasing the swelling, itching, and redness that can occur in these conditions. This medication is a medium-strength corticosteroid.

Since your skin condition may be present in areas other than the scalp, you may also be using other corticosteroid medications for those areas.

HOW TO USE: Shake the canister, turn it upside down, and spray out a small amount on a clean, cool surface (e.g., small plate or saucer). Do not spray the foam directly on the hands since warm skin will cause the foam to melt too quickly. Using your fingers, scoop up some of the foam and immediately massage the foam into the affected area of the scalp until the foam disappears. Repeat until the entire affected area is treated. Apply betamethasone foam usually twice daily or as directed by your doctor. Do not cover the treated area with bandages or other dressings unless instructed to do so by your doctor. Avoid contact of the foam with your eyes/nose/mouth. Wash your hands with soap and water after each use.

Dosage and length of treatment is based on your medical condition and response to the medication.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Inform your doctor if your condition persists or worsens. If there is no improvement in your symptoms after 2 weeks, your doctor may stop this medication.

SIDE EFFECTS: Burning, itching, or stinging at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Other effects may include acne.

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: hair loss, eye redness/irritation/pus, decreased skin color, skin dryness/thinning/stretch marks at the site of foam application, tingling/numbness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 betamethasone foam, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone, triamcinolone); or if you have any other allergies.

Though unlikely, it is possible this medication will be absorbed into your bloodstream, especially at higher doses or if you are also using corticosteroids on other parts of your body. This may result in worsening of certain conditions. If this applies to you, before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated active fungal infections, certain eye diseases (cataracts, glaucoma, herpes of the eye), underactive thyroid (hypothyroidism), diabetes, brittle bones (osteoporosis), certain infections (tuberculosis, positive tuberculosis test, other herpes infections), HIV, inactive infections (e.g., Ameba, Toxoplasma, Cryptococcus).

Caution is advised when using this drug in children because there is a slight risk that it may temporarily slow down a child's growth rate, but this will probably not affect final adult height. Though this effect is rare with corticosteroids applied to the skin such as betamethasone, monitor your child's height regularly.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby when the mother was taking other corticosteroids. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using high doses of betamethasone for an extended time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

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

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroids for the skin (e.g., clobetasol, triamcinolone), oral corticosteroids (e.g., predisone).

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: This medication may be harmful if swallowed. If swallowing or 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. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood sugar/salt levels, blood counts, height/weight measurements, blood pressure, eye examinations, X-rays, bone density tests) may be performed regularly to monitor your progress or check for side effects if this medication is used for prolonged periods. Consult your doctor for more details.

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 light and moisture. 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.

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