Picato

What is Picato used for?

Picato is a prescription medicine that is used to treat a precancerous skin problem called actinic keratosis.

Description

Picato^® (ingenol mebutate) gel, 0.015% or 0.05% is a clear colorless gel for topical administration, which contains the active substance ingenol mebutate, an inducer of cell death.

The chemical name of ingenol mebutate is:
2-Butenoic acid, 2-methyl-, (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta [a]cyclopropa[e]cyclodecen-6-yl ester, (2Z)
or
(1aR,2S,5R,5aS,6S,8aS,9R,10aR)-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11oxo-1a,2,5,5a,6,9,10,10a-octahydro-1H 2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6yl (2Z) 2 methylbut-2-enoate.

The molecular formula is C₂₅H₃₄O₆ and molecular weight is 430.5. Ingenol mebutate is represented by the following structural formula:

Ingenol mebutate is a white to pale yellow crystalline powder.

Picato^® gel, 0.015% and 0.05% contains 150 mcg and 500 mcg of ingenol mebutate, respectively in each gram of gel consisting of isopropyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, sodium citrate, benzyl alcohol and purified water.

Picato^® gel is clear colorless gel and supplied in unit dose laminate tubes, for single use, containing a nominal fill weight of 0.47 g, with a deliverable weight of 0.25 g. The tubes should be discarded after single use.

Before taking Picato, tell your doctor:

• If you are allergic to Picato; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If your skin has not healed from other care or surgery.
• If you are sunburned.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Picato with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Picato?

• Tell all of your health care providers that you take Picato. This includes your doctors, nurses, pharmacists, and dentists.
• If you get Picato in your eyes, it may cause eye problems like very bad eye pain, eyelid swelling or droop, or swelling around the eyes. Do not touch your eyes while using Picato. If you get Picato in your eyes, flush with water and call your doctor.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Make sure sores near the area to be treated are healed before using Picato.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may cause harm if swallowed. If Picato is swallowed, call a doctor or poison control center right away.
• People using Picato may have skin reactions where Picato is used. These reactions may include change in skin color, crusting, flaking, redness, scaling, scarring, or swelling. If these reactions get very bad, a break from using Picato may be needed as told by the doctor. Talk with the doctor.
• Call your doctor right away if you have a skin reaction that bothers you or if the reaction makes it hard to keep putting Picato on. Call your doctor right away if you have a skin reaction that causes problems with daily living.
• Very bad skin reactions and eye injuries have happened when Picato is not put on as told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Picato best taken?

Use Picato as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Picato by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina.
• Do not put Picato on the lips. Do not put near or around the eyes or mouth.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Use a new tube of gel each time you use Picato.
• Do not put on right after taking a shower or less than 2 hours before bedtime.
• Put a thin layer on the affected skin.
• Put on affected part only.
• Allow gel to dry for 15 minutes after using.
• Do not touch the area where Picato was put on the skin.
• Leave on the skin for 6 hours, then wash off.
• Do not bathe, shower, or swim for 6 hours after putting on.
• Avoid actions that may cause sweating for 6 hours after the gel is put on your skin.
• Do not cover with dressings.
• This medicine has gotten in the eyes on accident even after hand washing. This includes when putting on make-up or putting in contact lenses. Do not put on make-up or put in contact lenses right after using Picato. Use care to avoid getting Picato in the eyes.
• If you get Picato in the eyes, flush right away with cool water and get medical help.
• Do not get Picato on other parts of your body or on other people.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Picato that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a severe skin reaction (Stevens-Johnson syndrome) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Skin ulcers.
• Skin breakdown where Picato is used.
• Dizziness or passing out.

What are some other side effects of Picato?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Nose and throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Picato?

• Store in a refrigerator. Do not freeze.
• Throw away any part not used after use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

SRC: NLM .