Pronunciation:

klas-KOE-ter-one

Brand Names:

• Winlevi

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antiacne

Uses of This Medicine:

Clascoterone cream is used to treat acne vulgaris.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clascoterone cream in children 12 years of age and older. However, safety and efficacy of clascoterone cream have not been established in children younger than 12 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clascoterone cream in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients using this medicine.

Other 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.

Other interactions—

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:

• Eczema (skin problem) or
• Sunburn—May cause skin irritation and should not be used in patients with these conditions.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed. 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 your skin to be irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 or scrapes. If it does get on these areas, rinse it off right away.

To use the cream:

• Wash your hands with soap and water before and after you use this medicine.
• Gently wash and dry the affected skin area.
• After the skin is dry, apply a thin even layer of the cream to the affected areas.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

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 topical dosage form (cream):
  • For acne:
    • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin 2 times a day, in the morning and the evening.
    • Children younger than 12 years of age—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—

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

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.

Throw away the unused cream 180 days after the date of dispensing or 1 month after first opening, whichever is sooner.

Precautions While Using This Medicine:

It is important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

If your condition does not improve or if it become worse, check with your doctor.

Skin reactions including local skin irritation including itching, burning, skin redness or peeling, dryness, scaling, or stinging can occur when you use this medicine.

This medicine may cause adrenal or pituitary gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Unless your doctor tells you otherwise, you should avoid skin products that can dry or irritate the skin. Some examples are:

• Skin products that cause sensitivity to the sun, such as those containing spices or limes.
• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

Side Effects of This Medicine:

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

Darkening of the skin

diarrhea

faintness, especially after missing meals

irritability

itching or redness at the application site (severe)

loss of appetite

nausea

raised, dark red, wart-like spots on skin, especially when used on the face

reddish purple lines on arms, face, legs, trunk, or groin

unusual tiredness or weakness

vomiting

Rare

Dryness, discoloration, pain, or swelling at the application site

skin rash, hives, itching, or redness

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

Burning or stinging at the application site