Klisyri (tirbanibulin)

Each single-use 1% ointment packet contains 2.5 mg of tirbanibulin in 250 mg.

Tirbanibulin is available as single-dose ointment packets for topical use only; not for oral or ophthalmic use. A sufficient amount of tirbanibulin should be evenly applied to cover up to a 25 cm2 treatment field.

Store at 20-25degreesC (excursions permitted between 15-30degreesC). Do not refrigerate or freeze.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with tirbanibulin.

In vitro, tirbanibulin is principally metabolized by cytochrome P-450 (CYP) isoenzyme 3A4, and to a lesser extent, CYP2C8. Findings from in vitro studies suggest that tirbanibulin has no clinically meaningful effects on the pharmacokinetics of drugs metabolized by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4. Tirbanibulin also does not have clinically meaningful effects on drugs mediated by multidrug and toxin extrusion (MATE) transporter 1, MATE2-K, organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic cation transporter (OCT)1, or OCT2.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions reported in >=2% of patients receiving tirbanibulin include local skin reactions, application site pruritus, and application site pain.

There are no severe adverse reactions for this drug.

More Frequent

• Acute pain at drug application site
• Pruritus of skin

Less Frequent

• Erythema
• Localized edema
• Skin crusting
• Skin scaling
• Superficial skin ulcer

Rare or Very Rare

• Blistering skin

No enhanced messaging available.

The safety and efficacy of tirbanibulin have not been established in patients <18 years of age; however, actinic keratosis (AK) is generally not seen within the pediatric population.

No data are available on the use of tirbanibulin in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Animal reproductive data have shown tirbanibulin administered to rats during the period of organogenesis atleast 74 times the systemic exposure associated with the maximum recommended human dose (MRHD) results in an increased number of fetal deaths and malformations. Oral administration of tirbanibulin to rabbits during organogenesis at an exposure approximately 159 times the systemic exposure associated with the MRHD was associated with reduced mean fetal weight and size.

No data are available on the presence of tirbanibulin in human or animal milk. The effects of tirbanibulin on the breastfed child and its effects on milk production are unknown.

Consider the benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects from tirbanibulin on the breastfed child.

The manufacturer makes no specific dosage recommendations at this time. No differences in safety or efficacy have been observed between geriatric and younger adult patients; however, sensitivity of some older individuals cannot be ruled out. ,

Out of the 353 subjects with AK who received treatment with tirbanibulin in Phase 3 trials, 246 (70%) were >65 years of age. No overall differences in safety or efficacy were observed between these patients and younger adult patients. Other reported clinical experience has not identified differences in response, but greater sensitivity of some older individuals cannot be ruled out.