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Tirbanibulin: Drug information

Tirbanibulin: Drug information
(For additional information see "Tirbanibulin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Klisyri
Pharmacologic Category
  • Antineoplastic Agent, Antimicrotubular;
  • Topical Skin Product
Dosing: Adult
Actinic keratosis

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Dermatologic reactions

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.

Adverse Reactions

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)

Tirbanibulin: Adverse Reaction: Crusted Skin

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

Tirbanibulin: Adverse Reaction: Erythema of Skin

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

Tirbanibulin: Adverse Reaction: Exfoliation of Skin

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

Tirbanibulin: Adverse Reaction: Swelling of Skin

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)

Tirbanibulin: Adverse Reaction: Dermal Ulcer

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"

Tirbanibulin: Adverse Reaction: Pustules

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"

Tirbanibulin: Adverse Reaction: Skin Erosion

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"

Tirbanibulin: Adverse Reaction: Skin Vesicle

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%)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Ocular effects: May cause eye irritation; avoid contact with eyes or periocular area during and after application.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Klisyri: 1% (5 ea) [contains propylene glycol]

Generic Equivalent Available: US

No

Pricing: US

Ointment (Klisyri External)

1% (per each): $266.73

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Use: Labeled Indications

Actinic keratosis: Topical treatment of actinic keratosis on the face or scalp.

Medication Safety Issues
Sound-alike/look-alike issues:

Tirbanibulin may be confused with eribulin, terbanifine, terbutaline.

High alert medication:

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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.

Breastfeeding Considerations

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.

Monitoring Parameters

Monitor for local skin reactions and ophthalmic adverse reactions.

Mechanism of Action

Tirbanibulin is a microtubule inhibitor; it inhibits tubulin polymerization and disrupts Src kinase signaling, which are upregulated in actinic keratosis (Kempers 2020).

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: 88%.

Metabolism: Hepatic via CYP3A4 and CYP2C8 (minor) to inactive metabolites.

Time to peak: Median: ~7 hours.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Klisyri;
  • (BE) Belgium: Klisyri;
  • (DE) Germany: Klisyri;
  • (ES) Spain: Klisyri;
  • (GB) United Kingdom: Klisyri;
  • (IE) Ireland: Klisyri;
  • (IT) Italy: Klisyri;
  • (NL) Netherlands: Klisyri;
  • (PR) Puerto Rico: Klisyri
  1. Kempers S, DuBois J, Forman S, et al. Tirbanibulin ointment 1% as a novel treatment for actinic keratosis: phase 1 and 2 results. J Drugs Dermatol. 2020;19(11):1093-1100. doi:10.36849/JDD.2020.5576 [PubMed 33196758]
  2. Klisyri (tirbanibulin) [prescribing information]. Malvern, PA: Almirall LLC; August 2021.
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