tirbanibulin topical (Rx)

Brand and Other Names:Klisyri
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical ointment

  • 1% (single-dose packet)

Actinic Keratosis

Indicated for actinic keratosis of face or scalp

Apply to affected area (up to 25 cm2) on face or scalp qDay for 5 consecutive days

Use 1 single-dose packet per application

<18 years: Safety and efficacy not established

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Adverse Effects

>10%

Erythema, moderate (63%)

Flaking/scaling, moderate (47%)

Crusting, mild (30%)

Swelling, mild (29%)

Flaking/scaling, mild (26%)

Erythema, mild (22%)

Crusting, moderate (14%)

1-10%

Application site pain (10%)

Erosion/ulceration, mild (9%)

Swelling, moderate (9%)

Flaking/scaling, severe (9%)

Application site pruritus (9%)

Vesiculation/pustulation, mild (7%)

Erythema, severe (6%)

Erosion/ulceration, moderate (3%)

Crusting, severe (2%)

<1%

Vesiculation/pustulation, moderate-to-severe (<1%)

Swelling, severe (<1%)

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Warnings

Contraindications

None

Cautions

May cause eye irritation; avoid application into eyes and periocular area; if accidental exposure occurs, advise to flush eyes with water and seek medical care as soon as possible

Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) can occur

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Pregnancy & Lactation

Pregnancy

Data are unavailable on use in pregnant females to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

  • Oral administration to pregnant rats during organogenesis increased incidence of fetal deaths and malformations at a systemic exposure that was at least 74x the exposure associated with maximum recommended human dose (MRHD)
  • Oral administration to pregnant rabbits during organogenesis reduced mean fetal weight and size at a systemic exposure that was 159x exposure associated with the MRHD

Lactation

There are no data on drug presence in human or animal milk

Effects of drug on breastfed infants or on milk production are unknown

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Microtubule inhibitor

Mechanism of action for treatment of actinic keratosis is unknown

Absorption

Trough plasma concentration: 0.11 ng/mL

Peak plasma concentration: 0.18-0.34 ng/mL

AUC: 5 ng⋅hr/mL

Peak plasma time: ~7 hr

Steady-state reached at 72 hr

Distribution

Protein bound: 88%

Metabolism

Metabolized by CYP3A4 (mainly) and CYP2C8 (lesser extent)

After application, 2 inactive metabolites (KX2-5036 and KX2-5163) are detected

Elimination

Has not been fully characterized

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Administration

Topical Administration

For topical use only; not for oral or ophthalmic use

Apply sufficient amount using 1 single-dose packet per application to evenly cover up affected area

Wash hands immediately with soap and water after application

Avoid washing or touching treated area for ~8hr after application; after this 8-hr period, wash area with a mild soap

Avoid transfer to periocular area

Avoid application near and around mouth and lips

Storage

Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)

Do not refrigerate or freeze

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.