Verdeso

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a controlled clinical trial of 581 subjects aged 3 months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with VERDESO Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for VERDESO Foam and vehicle foam are noted in Table 1.

Table 1: Adverse Reactions in the Clinical Trial

Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.

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

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post-approval use of VERDESO Foam: application site irritation, application site erythema, application site reactions, skin reactions, and swelling face.

It is not likely that other drugs you take orally or inject will have an effect on topically applied desonide. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

In the U.S.

• Desonate
• Desowen
• LoKara
• Tridesilon
• Verdeso

In Canada

• Pms-Desonide

Available Dosage Forms:

• Gel/Jelly
• Ointment
• Cream
• Foam
• Lotion

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of desonide topical foam or gel in children 3 months of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam and gel forms, safety and efficacy have not been established in infants younger than 3 months of age. The safety and efficacy of desonide topical cream, lotion, and ointment have not been established in children and use is not recommended.

Geriatric

No information is available on the relationship of age to the effects of desonide topical cream, ointment, or lotion in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desonide topical foam or gel in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving desonide topical foam or gel.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

This section provides information on the proper use of a number of products that contain desonide. It may not be specific to Verdeso. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical gel on the groin or underarms unless directed to do so by your doctor, and do not use this form for more than 4 weeks.

To use cream, gel, lotion, or ointment:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

To use the foam:

• Wash your hands with soap and water before and after using this medicine.
• Shake the foam well before using it.
• Do not put the foam directly on your face. Turn the can upside down and place a small amount of medicine in your hands. Massage it gently into the affected areas of the face until the medicine has dried. For areas other than the face, you may put it directly on the affected area.
• Do not wash or rinse the treated area right after applying the medicine.
• Do not use this medicine near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For atopic dermatitis:
  • For topical dosage forms (foam or gel):
    • Adults and teenagers—Apply to the affected area of the skin two times per day.
    • Children 3 months of age and older—Apply to the affected area of the skin two times per day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
• For redness, itching, and swelling of the skin:
  • For topical dosage forms (cream, ointment, or lotion):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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:

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• flushing or redness of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• peeling of the skin
• raised, dark red, wart-like spots on the skin, especially when used on the face
• stinging and burning
• unusually warm skin

• Redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)

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:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Cold flu-like symptoms
• congestion
• cough
• hoarseness
• irritability
• noisy breathing
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• voice changes
• wheezing

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Verdeso, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Verdeso. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Verdeso (desonide foam).

Review Date: October 4, 2017

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Verdeso Foam or desonide. The effects of desonide on fertility have not been evaluated.

In a 90-day repeat-dose toxicity study in rats, topical administration of Verdeso Foam at dose concentrations from 0.025% to 0.125% or from 0.075 to 0.375 mg/kg/day of desonide resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ 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), 0.025%, 0.05%, and 0.125% desonide foam were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in albino hairless mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of desonide foam did not have an adverse effect in this study. The results of this study suggest that topical treatment with Verdeso Foam did not enhance photocarcinogenicity.

Desonide revealed no evidence of mutagenic potential based on the results of 2 in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).

See FDA-Approved Patient Labeling (Patient Information)

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 or other mucous membranes. The medication should not be dispensed directly onto the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly on the affected area. Wash hands after use.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician
4. Patients should report any signs of local or systemic adverse reactions to the physician.
5. Patients should inform their physicians that they are using Verdeso Foam if surgery is contemplated.
6. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
7. Do not use other corticosteroid-containing products while using Verdeso Foam without first consulting your physician.
8. The propellant in Verdeso Foam is flammable. Avoid fire, flame or smoking during and immediately following application.

VER-B-13

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of Verdeso is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Applies to desonide topical: compounding powder, topical cream, topical foam, topical gel, topical kit, topical lotion, topical ointment

General

The most commonly reported side effects were headache, insomnia, impetigo, skin infection, and rash.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction including facial edema[Ref]

Dermatologic

Common (1% to 10%): Impetigo, skin infection, rash
Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
Postmarketing reports: Pruritus, skin disorder[Ref]

Local

Frequency not reported: Burning, itching, irritation, dryness[Ref]

Other

Common (1% to 10%): Flu syndrome aggravated[Ref]

Nervous system

Common (1% to 10%): Headache, insomnia[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria, latent diabetes mellitus[Ref]

Some side effects of Verdeso may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.