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Drug overview for KLISYRI (tirbanibulin):
Generic name: tirbanibulin (TIR-ban-i-BUE-lin)
Drug class: Topical Antineoplastic Alkylating Agents
Therapeutic class: Dermatological
Tirbanibulin, a microtubule inhibitor, is a skin or mucous membrane agent.
No enhanced Uses information available for this drug.
Generic name: tirbanibulin (TIR-ban-i-BUE-lin)
Drug class: Topical Antineoplastic Alkylating Agents
Therapeutic class: Dermatological
Tirbanibulin, a microtubule inhibitor, is a skin or mucous membrane agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for KLISYRI (tirbanibulin) have been approved by the FDA:
Indications:
Actinic keratosis on the face or scalp
Professional Synonyms:
None.
Indications:
Actinic keratosis on the face or scalp
Professional Synonyms:
None.
The following dosing information is available for 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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| KLISYRI 1% (250 MG) OINT PKT | Maintenance | Adults apply 1 packet to the affected area(s) on the face and/or scalp by topical route once daily for 5 consecutive days |
| KLISYRI 1% (350 MG) OINT PKT | Maintenance | Adults apply 1 packet to the affected area(s) on the face and/or scalp by topical route once daily for 5 consecutive days |
No generic dosing information available.
The following drug interaction information is available for KLISYRI (tirbanibulin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KLISYRI (tirbanibulin):
Drug contraindication overview.
None.
None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for KLISYRI (tirbanibulin):
Adverse reaction overview.
The most common adverse reactions reported in >=2% of patients receiving tirbanibulin include local skin reactions, application site pruritus, and application site pain.
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 0 severe adverse reactions.
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute pain at drug application site Pruritus of skin |
Erythema Localized edema Skin crusting Skin scaling Superficial skin ulcer |
| Rare/Very Rare |
|---|
|
Blistering skin |
The following precautions are available for KLISYRI (tirbanibulin):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for KLISYRI (tirbanibulin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for KLISYRI (tirbanibulin)'s list of indications:
| Actinic keratosis on the face or scalp | |
| L57.0 | Actinic keratosis |
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