Product image of Klisyri (Tirbanibulin) supplied by GNH India

Klisyri

Active Ingredient:
Tirbanibulin
Origin:
EU

Klisyri (Tirbanibulin)

Tirbanibulin, the active ingredient in Klisyri, is a Src kinase inhibitor presented as a 1% (w/w) topical solution for topical use. It treats actinic keratosis in adult patients.
GNH India supplies Klisyri as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Almirall, S.A.

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Indications & Clinical Uses

  • Klisyri (tirbanibulin) is indicated for the treatment of actinic keratosis, a precancerous skin lesion caused by chronic ultraviolet exposure.
  • Actinic keratosis: reduces lesion size and number, helping to prevent progression to squamous cell carcinoma.

How It Works

  • Tirbanibulin inhibits Src family kinases and interferes with tubulin polymerisation, leading to cell‑cycle arrest in the G2/M phase and triggering apoptosis of abnormal keratinocytes. This dual action disrupts the proliferation of dysplastic skin cells characteristic of actinic keratosis, facilitating lesion clearance.

Side Effects

Klisyri may cause local skin reactions and, rarely, systemic hypersensitivity.

Common Side Effects

  • Redness at the application site
  • Itching or mild pruritus
  • Dryness or flaking of treated skin
  • Burning sensation
  • Mild swelling or edema
  • Crusting or scaling

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis)
  • Extensive skin ulceration
  • Contact dermatitis with blistering
  • Persistent erythema beyond the treatment area
  • Systemic hypersensitivity (e.g., fever, malaise)

Precautions & Warnings

Before using Klisyri, consider the following precautions:

  • Contraindication: known hypersensitivity to tirbanibulin or any excipients.
  • Avoid application on compromised skin or open wounds.
  • Do not use on mucous membranes or ocular surfaces.
  • Monitor for signs of severe local irritation or infection.
  • Pregnant or breastfeeding individuals should only use if the potential benefit justifies the potential risk.
  • Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Klisyri has a limited interaction profile, but the following should be considered:

Major Interactions (Avoid)

  • Concurrent use with other topical keratolytic agents (e.g., salicylic acid) may increase irritation.
  • Application together with potent corticosteroids may mask local adverse reactions.

Moderate Interactions (Monitor Closely)

  • Use with systemic immunosuppressants could theoretically affect wound healing.
  • Co‑administration of photosensitising drugs may exacerbate sun‑related skin damage.
  • Over‑the‑counter acne or wart treatments applied to adjacent areas should be spaced to reduce cumulative irritation.
  • Patients using extensive UV‑light therapy should limit exposure during treatment.

Frequently Asked Questions

Klisyri is a prescription dermatological agent containing tirbanibulin, indicated for the treatment of actinic keratosis, a precancerous skin lesion that arises from chronic sun exposure. It helps to clear existing lesions and reduces the risk of progression to squamous cell carcinoma.

Tirbanibulin blocks Src family kinases and interferes with tubulin polymerisation in abnormal keratinocytes. This dual inhibition halts cell‑cycle progression and induces programmed cell death, leading to the removal of dysplastic skin cells that characterize actinic keratosis.

The dosing regimen for Klisyri is determined by the prescribing clinician based on the product’s labeling and the patient’s specific condition. Healthcare professionals select the appropriate amount, frequency, and duration of application.

The pregnancy category for tirbanibulin is unknown. Klisyri should only be used during pregnancy or lactation if the potential therapeutic benefit justifies any potential risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.

To order Klisyri, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Klisyri’s tirbanibulin offers a short‑course, topical approach that directly targets Src kinases, whereas alternatives such as 5‑fluorouracil or imiquimod act through different mechanisms like DNA synthesis inhibition or immune modulation. Clinical data suggest comparable efficacy with a distinct safety profile focused on local skin reactions.

Klisyri should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Maintaining these conditions helps preserve the stability and potency of the 1 % tirbanibulin solution.

Klisyri is applied topically to the affected skin area as directed by a healthcare professional. The solution is spread thinly over each actinic keratosis lesion, ensuring even coverage while avoiding surrounding healthy skin.

Serious risks include severe allergic reactions such as anaphylaxis, extensive skin ulceration, and persistent erythema that may indicate a deeper tissue injury. Patients should seek immediate medical attention if they experience symptoms like swelling, blistering, or systemic signs of hypersensitivity.

Klisyri is contraindicated in individuals with a known hypersensitivity to tirbanibulin or any formulation components. It should also be avoided on compromised skin, open wounds, mucous membranes, and in patients where the risk of severe local irritation outweighs the therapeutic benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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