Actinic keratosis: Topical: Apply once daily to evenly cover up to a 25 cm2 area (using no more than 1 single-dose packet per application) for 5 consecutive days.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Local skin reactions (LSR), including crusted skin, dermal ulcer, skin erosion, erythema of skin, exfoliation of skin/scaling, pustules, skin vesicle, and swelling of skin may commonly occur. Most LSRs are mild and transient; however, severe LSRs have also been reported. Most LSRs spontaneously resolved/stabilized within 2 to 4 weeks during clinical trials (Ref).
Onset: Rapid; LSRs appear 2 to 4 days after initiation of therapy and peak by the end of treatment (Ref).
Risk factors:
• Occlusion following application
• Application to skin that has not fully healed from prior drug, procedure, or surgical treatment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Crusted skin (mild to moderate: 14% to 30%; severe: 2%) (table 1) , erythema of skin (63%; mild erythema of skin: 22%; severe erythema: 6%) (table 2) , exfoliation of skin (mild to moderate: 26% to 47%; severe: 9%) (table 3) , swelling of skin (mild to moderate: 9% to 29%; severe <1%) (table 4)
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
---|---|---|---|
Mild: 30% |
9% |
353 |
349 |
Moderate: 14% |
2% |
353 |
349 |
Severe: 2% |
0% |
353 |
349 |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
---|---|---|---|
Mild: 22% |
28% |
353 |
349 |
Moderate: 63% |
6% |
353 |
349 |
Severe: 6% |
0% |
353 |
349 |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
---|---|---|---|
Mild: 26% |
25% |
353 |
349 |
Moderate: 47% |
9% |
353 |
349 |
Severe: 9% |
0.3% |
353 |
349 |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
---|---|---|---|
Mild: 29% |
4% |
353 |
349 |
Moderate: 9% |
0.3% |
353 |
349 |
Severe: 0.6% |
0% |
353 |
349 |
1% to 10%:
Dermatologic: Dermal ulcer (mild to moderate: ≤9%) (table 5) , pustules (mild to moderate: ≤7%, severe: <1%) (table 6) , skin erosion (mild to moderate: ≤9%) (table 7) , skin vesicle (mild to moderate: ≤7%, severe: <1%) (table 8)
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
Comments |
---|---|---|---|---|
Mild: 9% |
3% |
353 |
349 |
Described as "Erosion/Ulceration" |
Moderate: 3% |
0% |
353 |
349 |
Described as "Erosion/Ulceration" |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
Comments |
---|---|---|---|---|
Mild: 7% |
0.9% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Moderate: 0.6% |
0% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Severe: 0.6% |
0% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
Comments |
---|---|---|---|---|
Mild: 9% |
3% |
353 |
349 |
Described as "Erosion/Ulceration" |
Moderate: 3% |
0% |
353 |
349 |
Described as "Erosion/Ulceration" |
Drug (Tirbanibulin) |
Placebo (Vehicle) |
Number of Patients (Tirbanibulin) |
Number of Patients (Vehicle) |
Comments |
---|---|---|---|---|
Mild: 7% |
0.9% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Moderate: 0.6% |
0% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Severe: 0.6% |
0% |
353 |
349 |
Described as "Vesiculation/Pustulation" |
Local: Application site pain (10%), application-site pruritus (9%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Ocular effects: May cause eye irritation; avoid contact with eyes or periocular area during and after application.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, External:
Klisyri: 1% (5 ea) [contains propylene glycol]
No
Ointment (Klisyri External)
1% (per each): $266.73
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Topical: Apply to keratotic lesions only; do not cover with an occlusive dressing. Wash hands immediately after application. Avoid washing or touching the treatment area for ~8 hours; may wash area with a mild soap and water after this time. Avoid application near or around the mouth, lips, or eyes. If accidental contact with eyes occurs, flush with water and contact health care provider.
Actinic keratosis: Topical treatment of actinic keratosis on the face or scalp.
Tirbanibulin may be confused with eribulin, terbanifine, terbutaline.
This medication is in a class the Institute for Safe Medication Practices includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
None known.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies following oral administration of tirbanibulin in doses providing greater systemic exposure than a maximum recommended human dose.
It is not known if tirbanibulin is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor for local skin reactions and ophthalmic adverse reactions.
Tirbanibulin is a microtubule inhibitor; it inhibits tubulin polymerization and disrupts Src kinase signaling, which are upregulated in actinic keratosis (Kempers 2020).
Protein binding: 88%.
Metabolism: Hepatic via CYP3A4 and CYP2C8 (minor) to inactive metabolites.
Time to peak: Median: ~7 hours.
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