GNH USA

Europe — EMA

Klisyri

GNH USA supplies Klisyri (tirbanibulin), a Src kinase inhibitor for actinic keratosis of the face and scalp.

Tirbanibulin

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What is Tirbanibulin?

Tirbanibulin, the active ingredient in Klisyri, is a Src kinase inhibitor presented as a 1% topical solution for topical use. It is indicated for the field‑directed treatment of actinic keratosis on the face and scalp in adult patients, providing a non‑surgical option to remove precancerous skin lesions and reduce the risk of progression to invasive cancer.

GNH USA supplies Klisyri as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled distribution across EU and other regulated markets while adhering to stringent regulatory standards.

What is Tirbanibulin used for?

Klisyri (tirbanibulin) is a topical antineoplastic agent used in the management of actinic keratosis, a precancerous skin condition. - Actinic keratosis (face and scalp): clears precancerous lesions and lowers the likelihood of progression to squamous cell carcinoma.

What are the side effects of Tirbanibulin?

Klisyri may cause local skin reactions that are generally mild to moderate.

Common Side Effects: - Erythema: redness at the application site. - Crusting: formation of dry scabs. - Scaling: flaking of treated skin. - Itching: mild to moderate pruritus. - Pain or burning: transient discomfort. - Dryness: reduced skin moisture.

Serious or Rare Side Effects: - Severe allergic reaction: swelling, hives, or difficulty breathing. - Contact dermatitis: intense irritation or rash. - Secondary infection: signs of bacterial or fungal involvement. - Ulceration: breakdown of skin tissue. - Persistent edema: prolonged swelling. - Systemic hypersensitivity: rare systemic immune response.

What precautions apply to Tirbanibulin?

Before prescribing Klisyri, clinicians should consider patient‑specific factors and monitor for adverse reactions. - Contraindication: Known hypersensitivity to tirbanibulin or any excipient. - Application area: Avoid use on broken, inflamed, or infected skin. - Mucosal surfaces: Do not apply to eyes, mouth, or genital mucosa. - Pregnancy and lactation: Safety not established; use only if benefit outweighs risk. - Pediatric use: Not established; limited to adult patients. - Store below 25°C: keep in the original container, protect from light and moisture.

What does Tirbanibulin interact with?

Topical tirbanibulin has limited systemic drug‑interaction potential, but co‑administration with certain agents may affect tolerability.

Major Interactions (Avoid): - Concurrent use of other topical antineoplastic agents on the same area: increased risk of severe skin toxicity. - Known allergy to formulation components: may trigger severe dermatitis.

Moderate Interactions (Monitor Closely): - Co‑application with keratolytic agents (e.g., salicylic acid): may enhance irritation. - Use with topical corticosteroids: could mask early signs of adverse skin reactions. - Photosensitizing drugs (e.g., tetracyclines): may increase sun‑induced skin sensitivity. - Systemic immunosuppressants: monitor for delayed wound healing. - Over‑the‑counter moisturizers containing irritants: assess for additive irritation.

Frequently asked questions

What is Klisyri used for?+
Klisyri is a prescription topical solution containing tirbanibulin that is used to treat actinic keratosis on the face and scalp. It works by removing precancerous skin lesions, helping to prevent progression to invasive skin cancer.
How does tirbanibulin work?+
Tirbanibulin blocks Src tyrosine kinase activity and disrupts tubulin polymerization in abnormal keratinocytes. This dual inhibition stops cell‑cycle progression, induces apoptosis, and leads to the clearance of actinic keratosis lesions.
What is the usual dose of Klisyri?+
The prescribed dose of Klisyri is determined by the treating physician. Typically, a thin layer is applied to the affected area once daily for a defined treatment period, but the exact regimen should follow the prescriber’s instructions.
Is Klisyri safe during pregnancy or breastfeeding?+
Safety of tirbanibulin in pregnancy and lactation has not been established. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified health professional.
How do I order Klisyri from GNH USA?+
To order Klisyri, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Klisyri compare with other actinic keratosis treatments?+
Klisyri offers a non‑surgical, field‑directed approach that differs from cryotherapy or topical 5‑fluorouracil. Its Src kinase inhibition provides targeted lesion clearance with a short treatment course, whereas other agents may require longer applications or cause broader skin irritation.
How should Klisyri be stored and handled?+
Store Klisyri below 25 °C in its original container, protected from light and moisture. Keep the product out of reach of children and avoid freezing. Do not use the solution after the expiration date printed on the label.
How is Klisyri applied?+
Klisyri is applied topically to clean, dry skin. A thin layer should be spread over the affected area of the face or scalp once daily, as directed by the prescriber, and left in place for the prescribed treatment duration.
What are the most serious risks associated with Klisyri?+
Serious risks include severe allergic reactions such as anaphylaxis, extensive contact dermatitis, secondary skin infection, and ulceration of the treated area. Patients should seek immediate medical attention if they experience swelling, difficulty breathing, or rapidly worsening skin lesions.
Who should not use Klisyri?+
Klisyri should not be used by individuals with known hypersensitivity to tirbanibulin or any formulation excipients, on broken or infected skin, or on mucosal surfaces. It is also not recommended for patients where safety in pregnancy or lactation cannot be assured.
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
Tirbanibulin
Route
Cutaneous Use
Manufacturer
Almirall, S.A.
Origin
EU

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