Drug Detail:Tirbanibulin topical (Tirbanibulin topical [ tir-ban-i-bue-lin-top-i-kal ])
Drug Class: Topical antineoplastics
Usual Adult Dose for Actinic Keratosis
Evenly cover up to 25 cm2 on the face or scalp once a day
Comments:
- Treat for 5 consecutive days using on single-dose pack per application.
- For topical use only; not for oral or ophthalmic use.
Use: For the topical treatment of actinic keratosis on the face or scalp
Renal Dose Adjustments
Data not available.
Liver Dose Adjustments
Data not available.
Precautions
CONTRAINDICATIONS:
- None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available.
Other Comments
Administration advice:
- For topical use only.
- Not for oral or ophthalmic use.
- Apply drug to evenly cover up to 25 cm2 of the affected area on the face or scalp once a day for 5 consecutive days using 1 single-dose packet per application.
- Wash hands immediately after application with soap and water.
- Avoid washing to touching the treated area for approximately 8 hours after the application.
- Avoid washing and touching the treated area for 8 hours after treatment, and after this time, the treated area can be washed with soap and water.
- Avoid application near the eyes, mouth, and lips.
Storage requirements:
- Store at 20C-25C (68F-77F), excursions permitted to 15C-30C (59F-86F)
- Do not refrigerate or freeze.
General:
- In clinical studies, the application of this drug to healthy subjects did not cause contact sensitization, phototoxic, or photoallergic skin reactions.
Patient advice:
- Patients should be advised to read the FDA-approved patient labeling.
- Patients should be advised to discard the packet after a single use.
- Advise patients that this drug is for topical use only and not for oral or ophthalmic use.
- Advise patients to avoid application around the eyes, mouth, and lips.
- Advise patients to flush eyes with water and seek medical care if accidental exposure occurs.
- Advise patients that this drug could irritate the skin.
- Advise patients to avoid washing and touching the treated area for 8 hours after treatment, and after this time, the treated area can be washed with soap and water.
