Ingenol mebutate

What is Ingenol mebutate?

• Ingenol mebutate (Picato gel) is an inducer of cell death used to treat actinic keratosis (thick, scaly growths on the skin that may become cancer).

What are the uses of this medicine?

• Picato gel, 0.015% is a prescription medicine used on the skin to treat actinic keratosis on the face or scalp.
• Picato gel, 0.05% is a prescription medicine used on the skin to treat actinic keratosis on the body or arms and legs.

How does this medicine work?

• The mechanism of action by which Picato gel induces cell death in treating AK lesions is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to ingenol mebutate or any of the ingredients in Picato gel.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Picato gel.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• For the treatment of actinic keratosis on the face or scalp Picato 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 or extremities Picato gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.

Administration:

• Use Picato gel exactly as your healthcare provider tells you. Picato gel is for skin use only.
• Your healthcare provider will tell you where to apply Picato gel, and how often, and how long to apply it. Do not apply Picato gel to other areas.
• Do not use more Picato gel than you need to cover the treatment area. Using too much Picato gel, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effects.
• Do not get Picato gel in, around, or near your eyes. Do not touch your eyes while you are applying Picato gel.
• Wash your hands well with soap and water after applying Picato gel. After applying Picato gel, be careful to keep Picato gel on the treated area from coming into contact with your eyes. Irritation may happen if you get Picato gel in your eyes.
• If you accidentally get Picato gel in your eyes, flush them with large amounts of water and get medical care as soon as possible. Also see "What are the possible side effects of Picato gel?"
• Do not get Picato gel in, around, or near your mouth or lips.
• To help prevent accidental transfer of Picato gel to other areas of your body or to another person:
• allow the treated area to dry for 15 minutes after you apply Picato gel.
• avoid washing and touching the treated area, or doing activities that cause a lot of sweating, for 6 hours after treatment. After 6 hours, you may wash the area with a mild soap and water.
• Only use a tube of Picato gel 1 time. Throw away any open tube of Picato gel after use even if there is medicine still left in it.
• Picato gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm × 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato gel and take care not to transfer the applied drug to other areas, including the eye. Patients should avoid washing and touching the treated area for a period of 6 hours after application of Picato gel. Following this time, patients may wash the area with a mild soap.
• Avoid transfer of Picato gel to periocular area.
• Avoid application near and around the mouth and lips.
• For topical use only; not for oral, ophthalmic, or intravaginal use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gel, 0.015% or 0.05%

This medicine is available in fallowing brand namesː

• Picato gel

What side effects can this medication cause?

The most common side effects of this medicine include:

• local skin reactions, see "Local skin reactions" above
• swelling around the eyes
• pain, itching, or skin irritation at the treatment area
• infection at the treatment area
• nose and throat irritation
• headache

Picato gel may cause serious or severe side effects including:

• Eye problems can happen if Picato gel gets in your eyes
• Serious allergic reactions
• Skin cancers
• Local skin reactions

What special precautions should I follow?

• Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Avoid accidental transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, flush eyes with water and seek medical care.
• Cases of non-melanoma skin cancer have been reported after treatment with Picato. Monitor patients with risk factors for skin cancer.
• Local skin reactions can occur including severe reactions (e.g., vesiculation/pustulation, erosion/ulceration). Administration of Picato gel is not recommended until skin is healed from any previous drug or surgical treatment.
• Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported postmarketing. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato gel immediately and institute appropriate medical therapy.

What to do in case of emergency/overdose?

• Symptoms of overdosage:
• overdosing of Picato gel could result in an increased incidence of local skin reactions.

Can this medicine be used in pregnancy?

• There are no available data on Picato gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Actinic keratosis is not a condition generally seen within the pediatric population.
• The safety and effectiveness of Picato gel for actinic keratosis in patients less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ingenol mebutate
• Inactive ingredients: isopropyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, sodium citrate, benzyl alcohol and purified water

Who manufactures and distributes this medicine?

• Manufactured by: LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland
• Distributed by: LEO Pharma Inc., Seven Giralda Farms, Madison, NJ, USA.

What should I know about storage and disposal of this medication?

• Store Picato gel in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.
• Picato 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 Picato gel tubes in household trash.
• Keep Picato gel and all medicines out of the reach of children.

• Dailymed label info on Ingenol mebutate
• FDA Ingenol mebutate

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