49/20. Tribanibulin -(KLISYRI)- ( Dec (2020)- To treat Actinic kerotosis of face or scalp
Drug Name:49/20. Tribanibulin -(KLISYRI)- ( Dec (2020)- To treat Actinic kerotosis of face or scalp
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
U.S. FDA APPROVED DRUGS DURING 2020
Sr.No- 49
Adverse Reaction:
ADVERSE REACTIONS
Most common adverse reactions (incidence =2%) are local skin reactions, application site pruritus, and application site pain.
Contra-Indications:
CONTRAINDICATIONS- None.
WARNINGS AND PRECAUTIONS
• May cause eye irritation upon ocular exposure. Avoid transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, flush eyes with water and seek medical care.
• Local skin reactions can occur including severe reactions (e.g., vesiculation/pustulation, erosion/ulceration) in the treated area. Avoid use until skin is healed from any previous drug or surgical treatment.
Dosages/ Overdosage Etc:
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Discard the packet after a single use.
Ophthalmic -Adverse Reactions-
Advise patients that KLISYRI 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
Local Skin Reactions-
Inform patients that treatment with KLISYRI may lead to local skin reactions.
Important Administration Instructions - Advise patients that KLISYRI is for topical use only.
Advise patients to avoid application near and around the eyes, mouth and lips.
Instruct patients to: • Wash hands well after applying KLISYRI to avoid transfer of the drug into the eyes and to the periocular area after application.
• Avoid washing and touching the treated area for 8 hours after treatment.
Following this time, patients may wash the area with a mild soap and water. • Avoid inadvertent transfer of KLISYRI to other areas, or to another person.
Manufactured for: Almirall, LLC Exton, PA 19341 USA Revised: December 2020
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 .Mechanism of Action- Tirbanibulin is a microtubule inhibitor. The mechanism of action of KLISYRI for the topical treatment of actinic keratosis is unknown.
2. Pharmacodynamics- The pharmacodynamics of tirbanibulin in the treatment of actinic keratosis is unknown.
3. Pharmacokinetics- Absorption- Following topical treatment of a mean daily dose of 138 mg (range: 54 to 295 mg) of KLISYRI to a 25 cm2 contiguous area of the face or balding scalp, once daily for 5 consecutive days, the steady-state concentration of tirbanibulin was achieved by 72 hours with a mean±SD trough concentration (Ctrough) of 0.11±0.08 ng/mL.
The median time to reach Cmax (Tmax) was ~7 hours.
Distribution- Plasma protein binding of tirbanibulin is 88% and is independent of concentrations in the range of 0.01 to 10 µg/mL.
Elimination- Metabolism - Following topical treatment with KLISYRI to adult subjects with actinic keratosis, the plasma concentrations of KX2-5036 and KX2- 5163, two pharmacologically inactive metabolites, were detectable with the highest plasma concentrations of 0.09 ng/mL and 0.12 ng/mL, respectively.
Excretion- Excretion of tirbanibulin has not been fully characterized in humans. Drug Interactions Clinical Studies No clinical studies evaluating the drug interaction potential of KLISYRI have been conducted.
Pregnancy and lactation:
USE IN SPECIFIC POPULATION
1. Pregnancy Risk Summary- There are no available data with KLISYRI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
2. Lactation Risk Summary- There are no data on lactational transfer of KLISYRI to human or animal milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KLISYRI and any potential adverse effects on the breastfed child from tirbanibulin or from the underlying maternal condition.
3.Pediatric Use- The safety and effectiveness of KLISYRI for actinic keratosis in subjects less than 18 years of age have not been e
4. Geriatric Use- Of the 353 subjects with AK treated with KLISYRI in the 2 controlled Phase 3 trials, 246 (70%) were 65 years of age or older.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
OVERDOSAGE - Overdose of KLISYRI could cause an increase in incidence and severity of local skin reactions.
