Klisyri 1% Ointment 5 Single/u Pkts
It is used to treat a precancerous skin problem called actinic keratosis.
Drug Class
Actinic Keratosis Agent
Pharmacologic Class
Microtubule Inhibitor
Pregnancy Category
Not available
FDA Approved
Dec 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Klisyri is a topical ointment used to treat rough, scaly patches on the skin called actinic keratosis, which are caused by too much sun exposure and can sometimes turn into skin cancer. You apply it to the affected areas on your face or scalp for 5 days.
How to Use This Medicine
Using This Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided below.
Application Instructions
Apply this medication only to the affected area of your skin, as directed by your doctor. Do not ingest or apply to mucous membranes, including your mouth, nose, or eyes, as it may cause burning.
Avoid applying the medication to the lips, near or around the eyes or mouth, or to open wounds, cuts, or damaged skin. Also, do not apply to areas that have not fully healed after surgery.
If you accidentally get the medication in your eyes, immediately flush with cool water and seek medical attention.
Before applying the medication, wash your hands and the affected area with mild soap and water. Dry the area thoroughly.
Use one packet per application, applying a thin layer to the affected area. Do not use more than necessary to cover the area.
After applying the medication, wash your hands with soap and water.
Post-Application Instructions
Apply the medication only to the affected area and avoid covering the area with bandages or dressings unless instructed to do so by your doctor.
For 8 hours after application, avoid washing or touching the treated area. After 8 hours, you may wash the area with mild soap and water.
To prevent exposure to others, avoid contact with the treated area for at least 8 hours after application. If someone else comes into contact with the treated area, have them wash the area with mild soap and water.
Lifestyle Precautions
Avoid activities that may cause excessive sweating.
Limit your exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing to minimize sun exposure.
Storage and Disposal
Store the medication at room temperature, avoiding refrigeration or freezing.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush down the toilet or pour down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal or to inquire about medication take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses. Limit application to once daily.
To use this medication safely and effectively, follow your doctor's instructions and the information provided below.
Application Instructions
Apply this medication only to the affected area of your skin, as directed by your doctor. Do not ingest or apply to mucous membranes, including your mouth, nose, or eyes, as it may cause burning.
Avoid applying the medication to the lips, near or around the eyes or mouth, or to open wounds, cuts, or damaged skin. Also, do not apply to areas that have not fully healed after surgery.
If you accidentally get the medication in your eyes, immediately flush with cool water and seek medical attention.
Before applying the medication, wash your hands and the affected area with mild soap and water. Dry the area thoroughly.
Use one packet per application, applying a thin layer to the affected area. Do not use more than necessary to cover the area.
After applying the medication, wash your hands with soap and water.
Post-Application Instructions
Apply the medication only to the affected area and avoid covering the area with bandages or dressings unless instructed to do so by your doctor.
For 8 hours after application, avoid washing or touching the treated area. After 8 hours, you may wash the area with mild soap and water.
To prevent exposure to others, avoid contact with the treated area for at least 8 hours after application. If someone else comes into contact with the treated area, have them wash the area with mild soap and water.
Lifestyle Precautions
Avoid activities that may cause excessive sweating.
Limit your exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing to minimize sun exposure.
Storage and Disposal
Store the medication at room temperature, avoiding refrigeration or freezing.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush down the toilet or pour down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal or to inquire about medication take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses. Limit application to once daily.
Lifestyle & Tips
- Avoid sun exposure, including tanning beds and sunlamps, during and after treatment. Use sunscreen and wear protective clothing.
- Wash hands thoroughly before and after applying the ointment.
- Avoid contact with eyes, lips, and inside of the nose/mouth. If accidental contact occurs, wash thoroughly with water.
- Do not apply to open wounds or broken skin.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply Klisyri 1% ointment to the affected area on the face or scalp once daily for 5 consecutive days.
Condition-Specific Dosing:
actinicKeratosis:
Apply to the affected area on the face or scalp once daily for 5 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment recommended.
Moderate:
No dosage adjustment recommended.
Severe:
No dosage adjustment recommended.
Dialysis:
No specific recommendations; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No dosage adjustment recommended.
Moderate:
No dosage adjustment recommended.
Severe:
No dosage adjustment recommended.
Confidence:
Medium
Pharmacology
Mechanism of Action
Tirbanibulin is a microtubule inhibitor. It binds to tubulin and inhibits its polymerization, leading to disruption of microtubule formation. This results in cell cycle arrest in the G2/M phase and ultimately induces apoptosis in rapidly proliferating cells, such as those found in actinic keratosis.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (Cmax < 1 ng/mL after topical application)
Tmax:
Not precisely quantifiable due to low systemic levels
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not precisely quantifiable due to low systemic levels
ProteinBinding:
Not precisely quantifiable due to low systemic levels
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantifiable due to low systemic levels
Clearance:
Not precisely quantifiable due to low systemic levels
ExcretionRoute:
Not precisely quantifiable due to low systemic levels
Unchanged:
Not precisely quantifiable due to low systemic levels
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 15 days of treatment initiation.
PeakEffect:
Full clearance may take up to 57 days post-treatment.
DurationOfAction:
Not precisely defined; sustained clearance observed at 12 months in clinical trials.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Blisters
- Skin ulcers
- Skin breakdown at the application site
- Pus at the application site
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor:
- Skin reactions at the application site, including redness, flaking, scaling, crusting, or swelling. If you notice severe skin irritation that bothers you or does not go away, inform your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Blisters
- Skin ulcers
- Skin breakdown at the application site
- Pus at the application site
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor:
- Skin reactions at the application site, including redness, flaking, scaling, crusting, or swelling. If you notice severe skin irritation that bothers you or does not go away, inform your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe local skin reactions (e.g., severe redness, swelling, blistering, open sores, or crusting that is painful or widespread).
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage and usage instructions provided by your doctor. Using more of this drug than prescribed, or using it more frequently or for a longer period than recommended, can increase the risk of severe side effects.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. In the event that this medication is ingested, it can be harmful. If swallowed, drink plenty of water immediately and contact a doctor or a poison control center right away.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. In the event that this medication is ingested, it can be harmful. If swallowed, drink plenty of water immediately and contact a doctor or a poison control center right away.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Systemic overdose is unlikely due to minimal absorption. Exaggerated local skin reactions may occur with excessive application.
What to Do:
Discontinue use and manage local skin reactions symptomatically. Call 1-800-222-1222 for poison control advice if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of actinic keratosis lesions
Rationale: To confirm diagnosis and establish baseline severity.
Timing: Prior to initiation of treatment.
Routine Monitoring
Local skin reactions (erythema, flaking/scaling, crusting, swelling, erosion/ulceration, blistering)
Frequency: Daily during treatment, then as needed during follow-up.
Target: Mild to moderate reactions are expected and generally manageable.
Action Threshold: Discontinue treatment and contact healthcare provider if severe local skin reactions occur or if reactions are intolerable.
Resolution of actinic keratosis lesions
Frequency: At 57 days post-treatment, and periodically thereafter (e.g., at 12 months).
Target: Complete or partial clearance of lesions.
Action Threshold: Consider alternative treatment if inadequate response or recurrence.
Symptom Monitoring
- Pain
- Itching
- Burning
- Stinging
- Tenderness
- Local skin reactions (erythema, flaking/scaling, crusting, swelling, erosion/ulceration, blistering)
Special Patient Groups
Pregnancy
There are no available data on Klisyri use in pregnant women. Animal studies showed developmental toxicity (e.g., skeletal malformations, reduced fetal weight) at systemic exposures higher than those expected in humans. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is unknown if tirbanibulin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for systemic effects in infant due to unknown excretion into milk and potential for absorption.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Klisyri is a short-course, 5-day topical treatment for actinic keratosis, which may improve patient adherence compared to longer regimens.
- Local skin reactions (e.g., redness, flaking, crusting) are common and expected. Patients should be counseled on these reactions and how to manage them (e.g., gentle cleansing, emollients).
- The full therapeutic effect, including complete clearance, may not be evident until 57 days after the 5-day treatment course.
- Emphasize strict adherence to the 5-day treatment regimen and proper application technique (thin layer, only to affected area).
- Advise patients to protect treated areas from sun exposure during and after treatment, as the skin may be more sensitive.
Alternative Therapies
- Topical 5-fluorouracil (5-FU)
- Topical imiquimod
- Topical ingenol mebutate (Note: withdrawn from market in some regions due to safety concerns, but historically used)
- Cryosurgery (liquid nitrogen)
- Photodynamic therapy (PDT)
- Curettage and electrodessication
- Chemical peels
- Laser resurfacing
Cost & Coverage
Average Cost:
$1000 - $1200 per 5 single-use packets (one course of treatment)
Insurance Coverage:
Tier 3 / Specialty
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.