KLISYRI

AbsorptionFollowing topical treatment of a mean daily dose of 348 mg (range: 224 to 435 mg) of KLISYRI to a 100 cm 2 contiguous area of the face or balding scalp, once daily for 5 consecutive days. On Day 5, systemic exposure to tirbanibulin had a mean±SD maximum plasma concentration (C max ) of 1.32±0.74 ng/mL and 0.71±0.31 ng/mL, and a mean±SD area under the plasma concentration from time zero to 24 hours (AUC 24 ) of 19.6±8.1 h∗ng/mL and 11.7±4.4 h∗ng/mL, in subjects who received the face an...

Actinic Keratosis of the Face or Scalp Two double-blind, vehicle-controlled clinical trials (NCT03285477 and NCT03285490) were conducted with 702 adult subjects with actinic keratosis on the face or scalp. Subjects were randomized 1:1 to KLISYRI or vehicle. Subjects enrolled had 4 to 8 clinically typical, visible, and discrete AK lesions in a contiguous area of 25 cm 2 on the face or scalp. Subjects had an average age of 70 years (range 45 to 96 years), were predominantly White (99%), male (87%), with Fitzpatrick skin types I or II (72%) and actinic keratosis on the face (68%) or scalp (32%). ...

Most common adverse reactions (incidence ≥2%) are local skin reactions, application site pruritus, and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall, at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another dr...

None. None. ( 4 )

Ophthalmic Adverse Reactions: May cause eye irritation upon ocular exposure. Avoid transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, flush eyes with water and seek medical care. ( 5.1 ) Local Skin Reactions: Local skin reactions can occur including severe reactions (e.g., vesiculation/pustulation, erosion/ulceration) in the treated area. Avoid use until skin is healed from any previous drug or surgical treatment. ( 5.2 ) 5.1 Ophthalmic Adverse Reaction...