Klisyri
- Generic Name: tirbanibulin ointment
- Brand Name: Klisyri
Klisyri (Tirbanibulin Ointment) side effects drug center
Klisyri Side Effects Center
What Is Klisyri?
Klisyri (tirbanibulin) Ointment is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.
What Are Side Effects of Klisyri?
Side effects of Klisyri include:
- local skin reactions (itching, pain, redness, flaking/scaling, crusting, swelling, blisters, and ulceration)
Dosage for Klisyri
Apply Klisyri to the treatment field on the face or scalp once daily for 5 consecutive days using 1 single-dose packet per application.
Klisyri In Children
The safety and effectiveness of Klisyri for actinic keratosis in subjects less than 18 years of age have not been established. Actinic keratosis is not a condition generally seen within the pediatric population.
What Drugs, Substances, or Supplements Interact with Klisyri?
Klisyri may interact with other medicines.
Tell your doctor all medications and supplements you use.
Klisyri During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Klisyri; it is unknown how it would affect a fetus. It is unknown if Klisyri passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Klisyri (tirbanibulin) Ointment, for Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Klisyri Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- redness, swelling, flaking, scaling, peeling, or crusting of treated skin; or
- blisters, pus, ulcers, or breakdown of your skin.
Common side effects may include:
- itching or pain where the medicine was applied.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Klisyri (Tirbanibulin Ointment)
Klisyri Professional Information
SIDE EFFECTS
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 drug and may not reflect the rates observed in clinical practice.
Two double-blind, vehicle-controlled clinical trials were conducted in 702 adult subjects with actinic keratosis on the face or scalp. Subjects were randomized 1:1 to KLISYRI or vehicle. Subjects enrolled in the trials had 4 to 8 clinically typical, visible, and discrete AK lesions in a contiguous area of 25 cm² on the face or scalp. Subjects had an average age of 70 years (range 45 to 96 years) and were predominantly Caucasian (99%), male (87%), with Fitzpatrick skin types I or II (72%) and actinic keratosis on the face (68%) or scalp (32%). Treatment groups were comparable across all demographics and baseline characteristics, including AK lesion count and distribution on the face or scalp.
In the controlled trials, local skin reactions (LSRs) were collected independent of adverse events. Local skin reactions including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosions/ulcerations were assessed by the investigators using a grading scale of 0 = absent, 1 = mild (slightly, barely perceptible), 2 = moderate (distinct presence), and 3 = severe (marked, intense).
The percentages of subjects with the maximal post-baseline grades for each local skin reaction greater than baseline by treatment group are provided in Table 1. LSRs were mostly mild to moderate in degree (Table 1).
Table 1 : Investigator Assessment of Maximal Post-Baseline Local Skin Reactions Greater Than Baseline in the Treatment Area (face or scalp) - Pooled Data from 2 Controlled Clinical Phase 3 Trials
| Local Skin Reactions | KLISYRI N = 353 | Vehicle N = 349 | ||||
| Mild n (%) | Moderate n (%) | Severe n (%) | Mild n (%) | Moderate n (%) | Severe n (%) | |
| Erythema | 76 (22%) | 223 (63%) | 22 (6%) | 98 (28%) | 20 (6%) | 0 |
| Flaking/ Scaling | 92 (26%) | 166 (47%) | 31 (9%) | 86 (25%) | 33 (9%) | 1 (<1%) |
| Crusting | 107 (30%) | 50 (14%) | 7 (2%) | 31 (9%) | 8 (2%) | 0 |
| Swelling | 102 (29%) | 32 (9%) | 2 (<1%) | 15 (4%) | 1 (<1%) | 0 |
| Vesiculation/ Pustulation | 25 (7%) | 2 (<1%) | 2 (<1%) | 3 (<1%) | 0 | 0 |
| Erosion/ Ulceration | 32 (9%) | 9 (3%) | 0 | 10 (3%) | 0 | 0 |
Table 2 presents the adverse reactions experienced in ≥2% of subjects participating in the controlled clinical trials with KLISYRI. No subject withdrew from the trials due to adverse reactions.
Table 2 :Adverse Reactions Occurring in ≥2% of Subjects in 2 Controlled Clinical Trials- Pooled Safety Population
| Adverse Reaction System Organ Class | KLISYRI N = 353 | Vehicle N = 349 |
| Number of Subjects (%) with any adverse reaction (possibly related to treatment) | 56 (16%) | 35 (10%) |
| Application site pruritus | 32 (9%) | 21 (6%) |
| Application site paina | 35 (10%) | 11 (3%) |
| a Application site pain includes pain, tenderness, stinging, and burning sensation at the application site. | ||
For the 51 subjects (45 KLISYRI, 6 vehicle) who maintained complete clearance through the 12-month follow-up period, no additional local adverse reactions were reported.
Dermal Safety Studies
Clinical studies in healthy subjects demonstrated KLISYRI did not cause contact sensitization (261 subjects), phototoxic skin reactions (31 subjects), or photoallergic skin reactions (64 subjects).
Read the entire FDA prescribing information for Klisyri (Tirbanibulin Ointment)
&Copy; Klisyri Patient Information is supplied by Cerner Multum, Inc. and Klisyri Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.