Ingenol Mebutate, Topical

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KEY POINTS

• This medicine is put on the skin to treat actinic keratosis. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: cell death inducer

Generic and brand names: ingenol mebutate, topical; Picato

What is this medicine used for?

This medicine is a gel that is used on the skin to treat actinic keratosis (a type of skin growth).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Other skin problems or sunburn in the treatment area
• Other medicines or surgery to treat actinic keratosis

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Apply the gel to your skin exactly as your healthcare provider prescribes. Do not use more or use it longer or more often than prescribed. This can increase your chance of having severe skin reactions. Follow the instructions in the medicine package for the right way to use the medicine.

Check with your healthcare provider before using this medicine in children under age 18.

Do not apply the gel to open wounds or to skin that is irritated, peeling, or infected. Do not apply right after taking a shower or less than 2 hours before bedtime. Do not cover the treated site with a bandage.

Put a thin layer of medicine on the area where you need it to completely cover the sores. Do not use more medicine than you need to cover the treatment area. Let the medicine dry for 15 minutes.

Wash your hands well with soap and water right after you apply this medicine. Take care not to get the medicine in your eyes, around your eyes, or on another person. Avoid washing or touching the skin where you put the medicine for at least 6 hours after you apply it. After 6 hours, you may wash the area with mild soap and water. The gel is for external use only.

Do not get the medicine into your eyes, nose, or mouth. If you accidentally get the gel into your eyes, flush them thoroughly with large amounts of cool water and contact your healthcare provider or seek medical care as soon as possible. This medicine can cause severe damage to your eyes.

Each gel tube is for single-use only. Discard any open tube after use, even if there is still medicine left in it. Talk with your healthcare provider about the proper way to discard the medicine.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

This medicine should not be used on children.

Contact your healthcare provider if your symptoms don't improve or if they get worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Painful or tingling skin; severe skin rash, ulcers, blisters, crusting, or sores; severe eye pain, redness, or swelling; eyelid swelling or drooping.

Other: Mild skin redness, flaking, scaling, crusting, or swelling; mild itchy skin; headache, runny or stuffy nose.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator. Do not let it freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.