Ingenol Mebutate

Ingenol mebutate is a prescription medication used to treat actinic keratosis (AK), a dry, rough, scaley patch of skin developing from too much sun exposure. Some actinic keratoses may develop into a type of skin cancer. Ingenol mebutate belongs to a group of drugs called cytotoxic agents, which causes cell death in AK skin lesions.

Ingenol mebutate gel 0.015% is a prescription medicine used on the skin to treat actinic keratosis on the face and scalp. 

Ingenol mebutate gel 0.05% is a prescription medicine used on the skin to treat actinic keratosis on the body, arms, and legs.

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

Ingenol Mebutate may be found in some form under the following brand names:

• Picato

Ingenol mebutate gel may cause severe side effects including:

• Eye problems can happen if the gel gets in your eyes. Eye problems may include severe eye pain, swelling or drooping of your eyelids, or swelling around your eyes. If you accidentally get ingenol mebutate gel in your eyes, flush them with large amounts of water and get medical care as soon as possible.

• Local skin reactions. Skin reactions in the treatment area are common with ingenol mebutate gel. You may get a skin reaction such as mild redness, flaking or scaling, crusting, or swelling. Call your healthcare provider if you get skin redness, flaking or scaling, crusting, or swelling that is more severe, or if you get blisters, pus, ulcers or breakdown of your skin.

The most common side effects with ingenol mebutate gel include:

• “local skin reactions,” see above
• pain, itching, or skin irritation at the treatment area
• infection at the treatment area
• nose and throat irritation
• headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ingenol mebutate gel. For more information, ask your healthcare provider or pharmacist.

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

No ingenol mebutate drug interactions have been identified, however, you should tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are being treated for actinic keratosis with surgery or other medications. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Ingenol Mebutatecan cause severe allergic reactions. Stop using Picato gel and seek immediate medical attention if you experience:

• throat tightness
• difficulty breathing
• feeling faint
• swelling of the lips or tongue
• hives
• itching
• severe skin rash

There have also been reports that ingenol mebutate can cause herpes zoster (shingles).

Ingenol Mebutate can cause severe eye injuries and skin reactions associated with the application of ingenol mebutate gel. Make sure to apply ingenol mebutate gel only as directed. 

Do not use this medication if you are allergic to ingenol mebutate.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ingenol mebutate there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use ingenol mebutate gel, tell your healthcare provider if you:

• are being treated or have been treated for actinic keratosis with other medicines or surgery. You should not use ingenol mebutate gel until your skin has healed from other treatments.
• have other skin problems or sunburn in the treatment area
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if this gel can harm your unborn baby.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ingenol mebutate falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if ingenol mebutate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ingenol mebutate gel.

• Use ingenol mebutate gel exactly as your healthcare provider tells you. Ingenol mebutate gel is for skin use only.

• Your healthcare provider will tell you where to apply ingenol mebutate gel, and how often, and how long to apply it. Do not apply ingenol mebutate gel to other areas.

• Do not use more Ingenol mebutate gel than you need to cover the treatment area. Using too much Ingenol mebutate gel, or using it too often, or too long can increase your chances for having a severe skin reaction or other side effects.
• Do not apply the gel in, near, and around the mouth, lips and eye area

• Do not get Ingenol mebutate gel in your eyes. Do not touch your eyes while you are applying ingenol mebutate gel. Wash your hands well with soap and water after applying ingenol mebutate gel. After applying Ingenol mebutate gel, be careful to keep ingenol mebutate gel on the treated area from coming into contact with your eyes. Irritation may happen if you get Ingenol mebutate gel in your eyes. If you accidentally get Ingenol mebutate gel in your eyes, flush them with large amounts of water and get medical care as soon as possible. 

• Do not get ingenol mebutate gel in your mouth.

• Only use a tube of ingenol mebutate gel 1 time. Throw away any open tube of ingenol mebutate gel after use even if there is medicine still left in it.

• See the Instructions for Use that comes with your ingenol mebutate gel for information about the right way to apply it.
• Do not cover the treated site with bandages or other closed dressings.

Always use ingenol mebutate gel exactly as your healthcare provider tells you.

For the treatment of actinic keratosis on the face and scalp ingenol mebutate gel 0.015% should be applied to the affected area once daily for 3 consecutive days.

For the treatment of actinic keratosis on the trunk and extremities ingenol mebutate gel 0.05% should be applied to the affected area once daily for 2 consecutive days.

If you have taken too much ingenol mebutate gel, or if it has been taken by mouth, call your local Poison Control Center or seek emergency medical attention right away.

• Store ingenol mebutate gel in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.
• Ingenol mebutate gel has an expiration date (exp) marked on the end of the tube. Do not use the gel after this date.

• Safely throw away used ingenol mebutate gel tubes in household trash.

Keep this and all medicines out of the reach of children.