Description
Tirbanibulin topical is used to treat actinic keratosis on the face or scalp.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Ointment
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tirbanibulin topical in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tibranibulin topical in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Other skin problems (eg, patients who have received treatment with other medicine, procedure, or surgery)—Should not be used until your skin has healed from other treatments.
Proper Use
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated.
This medicine is for use on the skin only. Do not get any of this medicine near or around your eyes, mouth, or lips. If it does get on these areas, rinse it off with water and check with your doctor right away, especially if you have red, sore eyes.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
To use the ointment:
- Use 1 single-dose packet with each application.
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin, even layer of the medicine to cover the affected area (up to 100 cm2) on the face or scalp.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
- Do not wash or touch the treated area for at least 8 hours after application. You may wash the area with mild soap and water after 8 hours.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage form (ointment):
- For actinic keratosis on the face or scalp:
- Adults—Apply to the affected area once a day for 5 consecutive days.
- Children—Use and dose must be determined by your doctor.
- For actinic keratosis on the face or scalp:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away any open packet after use even if there is still medicine left in it.
Precautions
It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.
If your condition does not improve or if it become worse, check with your doctor.
This medicine may cause serious skin reactions. Check with your doctor right away if you have blisters, peeling, pus, ulcers, cracking, redness, flaking, scaling, crusting, or swelling of the skin.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Cracking of the skin
- crusting of the skin
- dryness and peeling of the skin
- flushing, redness of the skin
- redness, blistering, peeling, or loosening of the skin
- skin ulcers
- swelling
- unusually warm skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Burning, stinging, or pain at the application site
- itching skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20506427
