What is Picato?

Ingenol topical is used to treat a skin condition called actinic keratosis.

This medicine is available only with your doctor's prescription.

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 unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye disorders (e.g., severe eye pain, swelling of the eyes or eyelids, or drooping of the eyelids). If any of the medicine does get in the eyes, wash the eyes with water and check with your doctor or other healthcare professional right away.

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.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present.

To use the gel:

• Wash your hands with soap and water before and after using the medicine.
• Apply a thin layer to the affected area of the skin. Rub it in gently. Wash your hands again.
• Allow the gel to dry for 15 minutes.
• Avoid washing and touching the treated area, or participating in activities that may cause heavy sweating for 6 hours after treatment.
• After 6 hours, you may wash the area with a mild soap and water.
• Do not bandage or otherwise wrap the skin being treated, unless directed to do so by your doctor. Materials that are not airtight, such as cotton gauze or cotton underwear, may be used if needed.
• Throw out any unused gel from the single-dose tube.

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 (gel):
  • For treatment of actinic keratosis on the face and scalp:
    • Adults—Apply a thin film of 0.015% gel to the affected area once a day for 3 consecutive days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of actinic keratosis on the trunk, arms, and legs:
    • Adults—Apply a thin film of 0.05% gel to the affected area once a day for 2 consecutive days.
    • Children—Use and dose must be determined by your doctor.

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.

Store in the refrigerator. Do not freeze.

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.

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:

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.

Appropriate studies on the relationship of age to the effects of ingenol topical for actinic keratosis have not been performed in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ingenol topical in the elderly.

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.

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.

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.

It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, pain, redness, swelling, bleeding, oozing, scabbing, or peeling on the skin where the medicine was applied. Do not use this medicine until your skin has healed from any previous drug or surgical treatment.

Do not use cosmetics or any other skin care products on the treated areas, unless directed to do so by your doctor.