Brand Name(s):

  • Picato®

    [Posted 08/21/2015]

    AUDIENCE: Dermatology, Pharmacy, Patient

    ISSUE: FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of ingenol mebutate (Picato) gel. FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of ingenol mebutate gel. Some cases were associated with ingenol mebutate gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. See the FDA Drug Safety Communication for additional information and recommendations.

    Patients should use ingenol mebutate gel as prescribed by their health care professionals, and should not use it on an area of skin larger or for a longer period than instructed in the drug label. Also patients should avoid applying the gel in, near, and around the mouth, lips and eye area. Accidental transfer of ingenol mebutate gel from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. Applying ingenol mebutate gel in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.

    The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue.

    BACKGROUND: Ingenol mebutate is used to treat actinic keratosis, a scaly, crusty lesion on the skin that may be red or yellow in color.

    RECOMMENDATION: Patients who experience a severe allergic reaction should stop using ingenol mebutate gel and seek immediate medical attention. The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue. Patients should also stop using the product and contact their health care professionals if they develop hives, itching, or severe skin rash. If accidental eye exposure occurs, flush the eyes thoroughly with water and seek medical care.

    For more information visit the FDA website at: Web Siteand Web Site.

    WHY is this medicine prescribed?

    Ingenol mebutate gel is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Ingenol mebutate is in a class of medications called cytotoxic agents. It works by killing fast-growing cells such as the abnormal cells associated with actinic keratoses.

    HOW should this medicine be used?

    Ingenol mebutate comes as a 0.015% or 0.05% gel to apply to the skin. When ingenol mebutate gel is used to treat actinic keratosis on the face or scalp, the 0.015% gel is usually applied once a day for 3 days in a row. When ingenol mebutate gel is used to treat actinic keratosis on the trunk (torso), arms, hands, or legs, the 0.05% gel is usually applied once a day for 2 days in a row. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ingenol mebutate gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

    Ingenol mebutate gel should only be used on the skin. Do not apply ingenol mebutate gel in or near your eyes, mouth, or vagina. If you get ingenol mebutate gel in your eyes, flush them with large amounts of water right away, and get medical care as soon as possible.

    Do not apply ingenol mebutate gel right after taking a shower or less than 2 hours before bedtime. After applying ingenol mebutate gel, avoid doing activities that cause a lot of sweating for at least 6 hours.

    To use ingenol mebutate gel, follow these steps:

  • Remove the cap from a new tube of ingenol mebutate gel just before you are ready to use it.
  • Squeeze the gel from the tube onto your fingertip. Use just enough gel to cover the area your doctor has instructed you to treat. One tube contains enough gel to cover a skin area of about 2 inches by 2 inches.
  • Spread the gel evenly over only the skin area you are treating.
  • Wash your hands right away after applying the gel. Be careful not to touch your eyes before you wash your hands. If the area you are treating is on your hands, wash only the fingertip you used to apply the gel.
  • Safely throw away the tube in the household trash after a single use.
  • Allow the treated area to dry for 15 minutes. Do not wash or touch the treated area for at least 6 hours. Be careful not to get the gel on the skin of another area of your body or to touch another person with the treated area.
  • Do not cover the treated area with bandages or other dressings.
  • After 6 hours, the treated area can be washed with mild soap and water.
  • Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and instructions for use.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before using ingenol mebutate gel,

  • tell your doctor and pharmacist if you are allergic to ingenol mebutate, any other medications, or any of the ingredients in ingenol mebutate gel. Ask your pharmacist or check the manufacturer's information for the patient for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any other treatments for actinic keratosis.
  • tell your doctor if you have other skin problems, including side effects from other treatments or sunburn, in the area you will be treating. You should not use ingenol mebutate gel until your skin has healed.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ingenol mebutate gel, call your doctor.
  • What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

    What SIDE EFFECTS can this medicine cause?

    Ingenol mebutate gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • redness, flaking, scaling, crusting, or swelling of the skin
  • pain, itching, or irritation of the treated skin
  • irritation of the nose and throat
  • headache
  • Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • eye pain, swelling or drooping of your eyelids, or swelling around your eyes
  • blisters, pus, ulcers, or other sores on the skin
  • Ingenol mebutate gel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator; do not freeze ingenol mebutate gel. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.

    Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: September 15, 2015.