Tirbanibulin

Tirbanibulin Topical is a prescription medication used to treat actinic keratosis, a skin condition caused by damage from repeated exposure to ultraviolet light from the sun and/or indoor tanning, and to treat actinic keratosis on the face or scalp.

• Tirbanibulin Topical is available under various brand names: Klisyri

Adult dosage

Topical ointment

• 1% (single-dose packet)

Actinic keratosis:

Adult dosage

• Topical  : Apply once daily to evenly cover up to a 25 cm2 area (using no more than 1 single-dose packet per application) for 5 consecutive days.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Tirbanibulin Topical   include:

• itching or pain where the medicine was applied.

Serious side effects of Tirbanibulin Topical   include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• redness, swelling, flaking, scaling, peeling, or crusting of treated skin; or
• blisters, pus, ulcers, or breakdown of the skin.

Rare side effects of Tirbanibulin Topical   include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tirbanibulin has no noted severe interactions with any other drugs.
• Tirbanibulin has no noted serious interactions with any other drugs.
• Tirbanibulin has no noted moderate interactions with any other drugs.
• Tirbanibulin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Aged below 18 years age

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tirbanibulin Topical  ?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tirbanibulin Topical  ?”

Cautions

• Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
• Do not get this medicine in your eyes. If contact does occur, rinse with water and call your doctor right away.
• Rinse with water if this medicine gets in your mouth or on your lips.
• Do not share this medicine with another person, even if they have the same symptoms you have.

Pregnancy and Lactation

• Tell your doctor if you are pregnant
• Data are unavailable on use in pregnant females to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Tell your doctor if you are breastfeeding.
  • There are no data on drug presence in human or animal milk
  • Effects of drug on breastfed infants or on milk production are unknown