Clinical author's note Michael Stewart 01/03/2020: In February 2020, the licence of ingenol mebutate (Picato®) was suspended as a precautionary measure while the European Medicines Agency (EMA) continues to investigate concerns about a possible increased risk of skin cancers. Ingenol mebutate will no longer be prescribed by doctors in the UK and EU. The advice for anyone who has used Picato® gel is to check your skin regularly and tell a doctor if you notice any new scaly red patches, open sores, or elevated or warty growths in the treatment area.
About ingenol mebutate gel
|Type of medicine||A topical treatment for sun-damaged skin|
|Used for||Treating solar keratosis|
|Also called||Picato® (discontinued)|
A solar keratosis is a small, thickened, scaly growth which develops on the skin. It is the most common skin condition resulting from sun-damaged skin. Solar keratoses are also known as actinic keratoses. Solar keratoses usually develop on areas of skin which have received a lot of sun exposure. They are usually harmless, but there is a small risk that they may eventually turn into skin cancer. In themselves, solar keratoses are not cancerous.
Topical treatments (meaning you apply them to the skin) are useful if you have a lot of small solar keratoses. Ingenol mebutate is one of the treatments that are available. It kills the abnormal skin cells and fresh normal skin grows back. The brand name for ingenol mebutate gel is Picato®. There are two strengths of gel: the lower strength (150 micrograms/gram) is used for keratoses on the face or scalp, and the higher strength (500 micrograms/gram) is used for keratoses on other areas of the body.
Before using ingenol mebutate gel
To make sure this is the right treatment for you, before you start using ingenol mebutate gel it is important that your doctor knows:
- If you are pregnant or breastfeeding.
- If you have ever had an allergic reaction to a skin preparation.
- If you are taking or using any other medicines. This includes any medicines you buy without a prescription, as well as herbal and complementary medicines.
How to use ingenol mebutate gel
- Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The manufacturer's leaflet will give you more information about ingenol mebutate and a full list of the side-effects which you may experience from using it.
- Use ingenol mebutate exactly as your doctor tells you to. Each tube is used for one application only, so open a new tube each time you use the gel. Find a convenient time in your day to apply it - do not use it straight after you have had a shower or bath, and do not use it less than two hours before you go to bed. Gently rub the gel on to the area to be treated and allow it to dry for about 15 minutes:
- If you are using the 150 micrograms/gram strength on your face or scalp, apply the gel once a day for three days in a row.
- If you are using the 500 micrograms/gram strength on your body or arms/legs, apply the gel once a day for two days in a row.
- Once you have used the gel, wash your hands well (unless they are the treated area) and try to avoid touching the area for the next six hours. Do not wash the treated area during this six hours.
- Only use ingenol mebutate on your skin - you must avoid it coming into contact with your eyes and mouth. If this does happen, wash the area with plenty of warm water straightaway.
- As you use the gel, the area of skin you are treating is likely to become red and swollen. After a week it may blister and peel, but then it will begin to heal. Expect this reaction to happen, but if it becomes severe or if you are concerned about it, speak again with your doctor.
Getting the most from your treatment
- Try to keep any regular appointments with your doctor. This is so your doctor can check on your progress.
- Some people find it helps to apply a moisturising cream to the skin around the damaged areas to help soften the skin.
- When you have had a lot of sun exposure, your risk of developing skin cancer on some other part of your skin is increased. Check your skin regularly and tell a doctor if you notice any changes, such as new moles, small dark patches developing, or a change in an existing mole.
- There is some general advice which will help prevent any further sun damage to your skin. Avoid being out in the sun between 11 am and 3 pm. Always use a broad-spectrum sunscreen with an SPF of 30 or higher, and which protects against both UVB and UVA light. Apply plenty of the sunscreen, and re-apply it regularly, particularly after swimming and if you are sweating a lot.
Can ingenol mebutate gel cause problems?
Local irritation including redness, itching, pain, swelling and peeling can all occur. These effects are normal and show that the gel is working. If the discomfort becomes severe or troublesome, or if you think the area may have become infected, you should contact your doctor for further advice. Also, up to 1 in 10 people using the gel have experienced headache as a side-effect of treatment. If this happens to you, ask your pharmacist to recommend a suitable painkiller.
If you experience any other symptoms which you think may be due to the gel, speak with your doctor or pharmacist.
How to store ingenol mebutate gel
- Keep all medicines out of the reach and sight of children.
- Store the gel in a refrigerator.
- The tubes are for single use only - do not store opened tubes to use later.
Important information about all medicines
This preparation is for use on the skin only. If someone swallows some of it, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
If you buy any medicines check with a pharmacist that they are safe to take with your other medicines.
If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking or using.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Further reading and references
Manufacturer's PIL, Picato® 150 micrograms/gram gel; Leo Laboratories Limited, The electronic Medicines Compendium. Dated November 2019.
Manufacturer's PIL, Picato® 500 micrograms/gram gel; Leo Laboratories Limited, The electronic Medicines Compendium. Dated November 2019.
British National Formulary 73rd Edition (Mar 2017); British Medical Association and Royal Pharmaceutical Society of Great Britain, London.