tirbanibulin

Therapeutic Classification: Actinic keratosis agents

Pharmacologic Classification: antimicrotubulars

Indications ⬆ ⬇

REMS

Actinic keratosis on face or scalp.

Action ⬆ ⬇

Acts as a microtubule inhibitor; however, mechanism for effect in actinic keratosis is unknown.

Therapeutic effects:

Reduction of actinic keratosis lesions.

Pharmacokinetics ⬆ ⬇

Absorption: Negligible systemic absorption following topical use.

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized in liver via the CYP3A4 isoenzyme and to a lesser extent by the CYP2C8 isoenzyme.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Top	unknown	7 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: crusting, erosion/ulceration, erythema, flaking/scaling, swelling, vesiculation/pustulation

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

(Adults ): Apply sufficient amount of ointment to affected area (within a 100 cm² contiguous area) once daily for 5 consecutive days.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess actinic keratosis lesions before starting and periodically during therapy.

Implementation ⬆ ⬇

Topical Apply sufficient amount of ointment to evenly cover up lesions on the face or scalp once daily for 5 consecutive days using one single-dose packet per application. Avoid application near and around the mouth and lips. Wash hands immediately with soap and water after application. Avoid washing and touching the treated area for about 8 hr after application. After this time, area may be washed with a mild soap. Avoid transfer of ointment to the periocular area.
- Do not apply an occlusive dressing; may cause irritation.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional if local skin reactions (redness, flaking, scaling, crusting, swelling that is more severe) or if blisters, peeling, pus, ulcers, or breakdown of skin occurs.
Advise patient that the medication is not for ophthalmic use. Advise patients to avoid application around the eyes and transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, advise patients to flush eyes with water and seek medical care.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction of actinic keratosis lesions.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

16110- Almirall, LLC
- 16110-391- Klisyri
  - 16110-391-05- 5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET

16110- Almirall, LLC
- 16110-391- Klisyri
  - 16110-391-55- 5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET

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Pronunciation ⬇

Classifications ⬆ ⬇