Clascoterone

What is Clascoterone?

• Clascoterone (Winlevi), is an androgen receptor inhibitor.

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Clascoterone Structural Formula V1

What are the uses of this medicine?

• Clascoterone (Winlevi), is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

How does this medicine work?

Clascoterone is an androgen receptor inhibitor.

The exact mechanism of action of clascoterone in the treatment of acne is not fully understood, but it is believed to work through multiple mechanisms:

• Androgen Receptor Antagonism: Clascoterone competitively binds to the androgen receptor in the sebaceous gland and hair follicles, inhibiting the binding of natural androgens, such as dihydrotestosterone (DHT). This reduces the activation of the androgen receptor, leading to decreased sebum production.
• Inhibition of Sebaceous Gland Activity: By blocking the androgen receptor, clascoterone helps reduce the size and activity of the sebaceous glands. Sebaceous glands produce sebum, an oily substance that can contribute to the development of acne when excessive.
• Anti-inflammatory Effects: Clascoterone has anti-inflammatory properties that can help reduce inflammation associated with acne. It inhibits the production of pro-inflammatory molecules, such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α), which play a role in the inflammatory response of acne.
• Anti-Androgenic Effects: Clascoterone has mild anti-androgenic effects, which means it can counteract the effects of androgens, such as DHT, on the skin. Androgens can stimulate the growth of sebaceous glands and contribute to the development of acne.

By targeting the androgen receptor and reducing sebum production, inhibiting sebaceous gland activity, and exerting anti-inflammatory effects, clascoterone helps to control acne and improve the appearance of the skin.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• The medication, developed by Cassiopea and Intrepid Therapeutics, was approved by the US Food and Drug Administration (FDA) for acne in August 2020.
• The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Recommended dosage:

• Apply a thin layer (approximately 1 gram) to affected area twice daily (morning and evening).

Administration:

• Winlevi cream is for use on the skin only (topical). Do not use Winlevi cream in or on your eyes, mouth, or vagina.
• Use Winlevi cream exactly as your healthcare provider tells you to use it.
• Before applying Winlevi cream, gently wash and dry the affected skin area.
• After the skin is dry, apply a thin even layer of Winlevi cream to the affected areas 2 times each day, in the morning and the evening.
• Wash your hands after applying Winlevi cream.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream 1%.

This medicine is available in fallowing brand namesː

• Winlevi

What side effects can this medication cause?

The most common side effects of this medicine include:

• reddening, scaling or dryness, and itching of the skin being treated

Less common,but serious side effects may include:

• Local skin reactions
• adrenal insufficiency

What special precautions should I follow?

• Avoid using Winlevi cream on skin areas with cuts, abrasions, eczema, or on sunburned skin.
• Avoid getting Winlevi cream into your eyes, lips, mouth, corners of the nose, or mucous membranes. If contact with mucous membranes happens, rinse well with water.

Avoid using skin products that may dry or irritate your skin such as:

• medicated or abrasive soaps and cleansers
• soaps, cleansers, and cosmetics that have strong skin drying effects
• products that contain high amounts of alcohol
• astringents, spices, or lime
• Winlevi cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness).
• Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. If HPA axis suppression develops, an attempt should be made to withdraw the drug. Pediatric patients may be more susceptible to systemic toxicity.
• It is not known if Winlevi cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Winlevi cream.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Winlevi cream will harm your unborn baby.

Can this medicine be used in children?

• It is not known if Winlevi cream is safe and effective in children under 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: clascoterone
• Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, mineral oil, mono- and di-glycerides, polysorbate 80, propylene glycol, purified water, and vitamin E.

Who manufactures and distributes this medicine?

• Manufactured in Italy for: Sun Pharmaceutical Industries Limited
• Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ
• Winlevi is a licensed trademark of Cassiopea, S.p.A. exclusively licensed by Sun Pharmaceutical Industries, Ltd.

What should I know about storage and disposal of this medication?

• Store Winlevi cream at room temperature between 68°F and 77°F (20°C to 25°C).
• Do not freeze.
• Throw away (discard) the unused portion 180 days after the date of dispensing or 1 month after first opening, whichever is sooner.

• Dailymed label info on Clascoterone
• FDA Clascoterone