Ingenol Mebutate (IN-je-nol MEB-ue-tate)

Treats actinic keratosis.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use the 0.015% gel on the affected areas of your face and scalp for 3 days in a row. Use the 0.05% gel on the affected areas of your trunk, arms, and legs for 2 days in a row.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth. Do not get any of this medicine near or around your eyes, mouth, or lips. Do not apply this medicine to your nipple or areola, if you are breastfeeding.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Let the gel 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. Avoid heavy sweating during this time. After 6 hours, you may wash your skin with mild soap and water.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store this medicine in the refrigerator. Do not freeze it.

Drugs and Foods to Avoid:

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

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eye problems or other skin problems.
• This medicine may cause the following problems:
  • Eye problems
  • Skin cancer, including non-melanoma skin cancer
  • Serious skin reactions
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• New or changing rash or bumps on the skin
• Severe blisters, pus, oozing, scabs, or sores on the skin
• Severe eye pain, swelling or drooping of your eyelids, or swelling of your eyes
• Severe itching, flaking, swelling, pain, or redness of the skin
• Trouble breathing or chest pain

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

• Headache, sore throat
• Mild redness, flaking, swelling, itching, or other mild skin problems
• Pain or itching where the medicine is applied

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