GNH USA

Europe — EMA

Winlevi

GNH USA supplies Winlevi (Clascoterone), a steroidal antiandrogen for acne vulgaris. Request a quote for global supply.

Clascoterone

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What is Clascoterone?

Clascoterone, the active ingredient in Winlevi, is a steroidal antiandrogen presented as a 1% cream for topical use. It is indicated for the treatment of acne vulgaris in individuals aged 12 years and older. GNH USA supplies Winlevi as a licensed, GDP-compliant international pharmaceutical supplier serving pharmacies and clinics worldwide.

Winlevi is a first-in-class topical androgen receptor inhibitor designed to reduce sebum production and inflammation associated with acne. It offers a novel approach to managing acne by targeting the underlying hormonal factors that contribute to the condition.

What is Clascoterone used for?

Winlevi is used in the treatment of acne vulgaris, a common skin condition characterized by the presence of comedones, papules, pustules, and nodules. It is particularly effective in reducing sebum production, which is a key factor in the development of acne.

- Acne vulgaris: Reduces sebum production and inflammation, helping to clear acne lesions and prevent new ones from forming. - Adolescent acne: Effective in managing acne in individuals aged 12 years and older. - Adult acne: Provides a treatment option for adults who suffer from persistent acne.

What are the side effects of Clascoterone?

Winlevi may cause certain side effects, although not everyone experiences them. Common Side Effects: - Reddening, scaling, or dryness of the skin being treated. - Itching of the skin being treated. - Skin irritation, including burning or peeling.

Serious or Rare Side Effects: - Symptoms of adrenal insufficiency, such as fatigue, weakness, or weight loss. - Severe skin irritation or allergic reactions. - Eye, mouth, or vaginal irritation if the cream comes into contact with these areas.

What precautions apply to Clascoterone?

Before using Winlevi, it is important to consider certain precautions to ensure safe and effective treatment. Consult your healthcare provider if you: - Have skin problems, including eczema, cuts, or sunburn. - Are pregnant or plan to become pregnant, as the safety of Winlevi during pregnancy is unknown. - Are breastfeeding or plan to breastfeed, as it is not known if Winlevi passes into breast milk. - Have a history of adrenal insufficiency or other hormonal disorders. - Are using other topical medications, as they may interact with Winlevi. - Store at room temperature: Keep in the original pack, protect from moisture and heat.

What does Clascoterone interact with?

Winlevi may interact with other medications, so it is important to inform your healthcare provider about all the medications you are taking. Major Interactions (Avoid): - Other topical medications that may cause skin irritation or dryness. - Systemic medications that affect adrenal function.

Moderate Interactions (Monitor Closely): - Topical corticosteroids, as they may increase the risk of skin irritation. - Other topical acne treatments, as they may exacerbate skin dryness or irritation. - Hormonal medications, as they may affect the efficacy of Winlevi.

Frequently asked questions

What is Winlevi used for?+
Winlevi is used to treat acne vulgaris in individuals aged 12 years and older. It works by reducing sebum production and inflammation, which are key factors in the development of acne. Winlevi is particularly effective in managing both adolescent and adult acne.
How does Clascoterone work?+
Clascoterone, the active ingredient in Winlevi, acts as a topical androgen receptor antagonist. It blocks the binding of dihydrotestosterone (DHT) to androgen receptors in the skin, thereby reducing sebum production and inflammation. This mechanism helps to address the hormonal factors that contribute to the development of acne.
What is the usual dose of Winlevi?+
The usual dose of Winlevi is determined by your healthcare provider based on your specific needs and the severity of your acne. It is typically applied topically to the affected areas once or twice daily. Always follow the instructions provided by your healthcare provider.
Is Winlevi safe during pregnancy or breastfeeding?+
The safety of Winlevi during pregnancy or breastfeeding is unknown. It is important to consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before using Winlevi. Your healthcare provider can provide guidance based on your specific situation.
How do I order Winlevi from GNH USA?+
To order Winlevi from GNH USA, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will reply with pricing, availability, shipping, and the necessary import paperwork.
How does Winlevi compare to other acne treatments?+
Winlevi is a first-in-class topical androgen receptor inhibitor, making it unique among acne treatments. Unlike other topical treatments that primarily target bacteria or inflammation, Winlevi directly addresses the hormonal factors that contribute to acne. This makes it an effective option for both adolescent and adult acne.
How should Winlevi be stored and handled?+
Winlevi should be stored at room temperature, away from moisture and heat. Keep the cream in its original pack to protect it from contamination. Avoid freezing the cream and ensure it is kept out of reach of children. Always follow the storage instructions provided with the product.
How is Winlevi applied?+
Winlevi is applied topically to the affected areas of the skin. It is important to follow the instructions provided by your healthcare provider. Typically, a small amount of cream is applied to the affected areas once or twice daily. Avoid contact with the eyes, mouth, and vagina, as it may cause irritation.
What are the most serious risks to watch for with Winlevi?+
The most serious risks associated with Winlevi include symptoms of adrenal insufficiency, such as fatigue, weakness, or weight loss. Severe skin irritation or allergic reactions are also possible. If you experience any of these symptoms, consult your healthcare provider immediately.
Who should not use Winlevi?+
Winlevi should not be used by individuals under the age of 12, as its safety and effectiveness in this age group have not been established. It should also be used with caution in individuals with a history of adrenal insufficiency or other hormonal disorders. Always consult your healthcare provider before using Winlevi.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Clascoterone
Route
Cutaneous Use
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Origin
EU

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