Ingenol (IN-je-nol)

Treats actinic keratosis (AK), a skin problem.

Brand Name(s):

Picato

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• If you are using this medicine for the face and scalp, use the 0.015% gel to the affected area for 3 consecutive days. If you are using this medicine for the trunk, arms, and legs, use the 0.05% gel to the affected area for 2 consecutive days.
• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected area. Rub it in gently.
• Wait for the gel to dry for 15 minutes after you apply it.
• Do not wash or touch the treated skin area for 6 hours after you apply the medicine. Also do not do any activities that may cause heavy sweating for at least 6 hours after treatment.
• After 6 hours, you may wash the skin area with a mild soap and water.
• Do not cover the treated area with a bandage unless your doctor has told you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, apply it as soon as you can. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store this medicine in the refrigerator. Do not freeze it.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use cosmetics or other skin care products on the treated skin areas.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any skin infections.
• Do not use this medicine on skin that has not healed from any previous drug or surgical treatment.
• Do not get any of this medicine in or near your eyes, because it could cause severe eye pain or swelling. Wash your eyes with water and call your doctor right away if you do get medicine in your eyes.
• This medicine often causes a reaction on the skin. Most of the time the reaction is mild, such as a little redness, flaking, or swelling. Call you doctor if you have any severe or serious reaction. Some of the symptoms might be blisters, sores, pus, or severe swelling or redness.
• Do not use this medicine for a skin problem that has not been checked by your doctor.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Severe skin problems, such as
  • Blisters, pus
  • Flaking
  • Itching
  • Oozing, scabs
  • Pain
  • Redness
  • Sores
  • Swelling

If you notice these less serious side effects, talk with your doctor:

• Mild skin redness, flaking, swelling, itching, or other mild skin problems

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088