Winlevi

Acne Treatment

Winlevi is a prescription medication used on the skin to treat acne vulgaris. It is approved for use in adults and pediatric patients who are 12 years of age and older.

This treatment is used to address acne by targeting specific triggers in the skin that lead to breakouts. It is suitable for both males and females and is applied directly to the affected areas of the skin.

Healthcare providers may prescribe this cream to help manage:

• Common acne (acne vulgaris) on the face or body.
• Acne influenced by hormonal activity in the skin.

Mechanism of Action

Winlevi contains the active ingredient clascoterone, which is an androgen receptor inhibitor. It is specifically designed to target the hormonal pathways in the skin that contribute to the development of acne.

Targeting Androgen Receptors

Acne is often driven by hormones called androgens, which are found in both men and women. These hormones bind to androgen receptors located in the sebaceous glands (oil-producing glands) and hair follicles of the skin. When these receptors are activated, they signal the skin to produce more oil and can trigger inflammation.

Winlevi works by competing with these hormones for the androgen receptors. By blocking the receptors, the medication prevents the hormones from sending signals that lead to acne formation. This process helps to:

• Reduce Sebum Production: By limiting hormonal activity in the oil glands, the medication helps decrease the amount of excess oil (sebum) produced by the skin.
• Decrease Inflammation: Blocking these receptors also helps reduce the inflammatory response that leads to red, painful acne bumps.

Local Effect

Although the exact way clascoterone works is not fully understood, it is believed to act primarily on the area of the skin where it is applied. This allows it to address the hormonal causes of acne locally without significantly impacting hormone levels in the rest of the body.

Common Side Effects

Most side effects from Winlevi occur on the skin where the medication is applied. These reactions are typically mild and may include:

• Redness (erythema)
• Itching
• Scaling or peeling
• Dryness
• Stinging or burning
• Swelling at the application site

Serious Side Effects

Although rare, Winlevi can be absorbed into the body and cause systemic side effects. Contact a healthcare provider if you experience:

• Adrenal insufficiency: This occurs when the hypothalamic-pituitary-adrenal (HPA) axis is suppressed. Symptoms include extreme tiredness, muscle weakness, nausea, or dizziness.
• Allergic reactions: Seek emergency help for signs of a serious allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.
• High potassium levels: Some patients may experience elevated potassium in the blood (hyperkalemia).

The risk of systemic side effects is higher if the cream is used on large areas of the body or for a long period of time.

Local Skin Irritation

Winlevi can cause skin reactions at the site of application. Common symptoms include:

• Redness (erythema)
• Scaling or peeling
• Dryness
• Itching, stinging, or burning

If these reactions are severe, a healthcare provider may recommend reducing the frequency of use or pausing the medication.

HPA Axis Suppression

The active ingredient in Winlevi can be absorbed through the skin into the bloodstream, which may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression. This condition occurs when the body's natural production of hormones, such as cortisol, is reduced. The risk of HPA axis suppression increases if the medication is applied to large areas of the body or used for extended periods.

If HPA axis suppression is suspected, a healthcare provider may perform an ACTH stimulation test. If suppression is confirmed, discontinuation of the medication is typically required.

Specific Populations

The safety and effectiveness of Winlevi have not been established in children under 12 years of age. There is also limited information regarding the use of this medication during pregnancy or while breastfeeding. Healthcare providers can help evaluate the potential risks and benefits before use in these populations.

Pregnancy

There are no adequate and well-controlled studies of Winlevi use in pregnant women. Consequently, it is unknown if the medication increases the risk of major birth defects, miscarriage, or other adverse outcomes for the mother or the fetus. In animal studies where the medication was administered at doses significantly higher than those absorbed through human skin, some developmental issues were observed. Winlevi should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the unborn baby.

Breastfeeding

It is not known whether clascoterone, the active ingredient in Winlevi, is present in human breast milk. There is also no data available regarding the effects of the drug on a nursing infant or on milk production. Because many drugs are excreted in human milk, caution should be exercised when Winlevi is used by a person who is breastfeeding. To minimize the risk of the infant accidentally ingesting or coming into contact with the medication, avoid applying the cream to the breast or nipple area.

Available Forms

Winlevi is supplied in the following form:

• Topical Cream: This medication is a cream intended for application directly to the skin areas affected by acne.

It is for external use only and should not be applied to the eyes, mouth, or mucous membranes.

FDA Approval Status

Winlevi (clascoterone) received approval from the U.S. Food and Drug Administration (FDA) in August 2020. It is classified as an androgen receptor inhibitor and was the first medication of this type approved for topical use in treating acne.

Approved Indications

The FDA has approved Winlevi for the following use:

• Topical treatment of acne vulgaris in patients 12 years of age and older.

Safety and Regulatory Requirements

At this time, Winlevi does not have any boxed warnings, which are the FDA's most serious warnings for medications. There is also no Risk Evaluation and Mitigation Strategy (REMS) required for its distribution or use. The medication is available by prescription only.

Factors Influencing Cost

The price of Winlevi can vary based on several factors, including your geographic location and the specific pharmacy you choose. Because it is a prescription-only medication, retail prices are set by individual pharmacies.

Insurance Coverage

Your out-of-pocket cost will depend largely on your health insurance plan. Many insurance providers include Winlevi on their formulary, but the copayment amount can vary depending on the plan's drug tiers. Some insurance companies may require prior authorization, which means your healthcare provider must submit documentation to justify the use of the medication before the insurer will cover it.

Generic Availability

There is currently no generic version of Winlevi (clascoterone) available. Brand-name medications typically cost more than generics because they are protected by patents that prevent other manufacturers from producing the same drug for a set period of time.

Financial Assistance

The manufacturer may offer savings cards or patient assistance programs to help lower the cost for eligible patients. These programs are often designed for individuals with commercial insurance or those who meet specific financial requirements. You can ask your pharmacist or healthcare provider about available options to help manage the cost of the medication.