Ingenol Mebutate Topical

IMPORTANT WARNING:

Ingenol Mebutate is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued

Because this drug is no longer available in the U.S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information.

WHY is this medicine prescribed?

Ingenol mebutate gel is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Ingenol mebutate is in a class of medications called cytotoxic agents. It works by killing fast-growing cells such as the abnormal cells associated with actinic keratoses.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Ingenol mebutate comes as a 0.015% or 0.05% gel to apply to the skin. When ingenol mebutate gel is used to treat actinic keratosis on the face or scalp, the 0.015% gel is usually applied once a day for 3 days in a row. When ingenol mebutate gel is used to treat actinic keratosis on the trunk (torso), arms, hands, or legs, the 0.05% gel is usually applied once a day for 2 days in a row. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ingenol mebutate gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Ingenol mebutate gel should be used only on the skin. Do not apply ingenol mebutate gel in or near your eyes, mouth, or vagina. If you get ingenol mebutate gel in your eyes, flush them with large amounts of water right away, and get medical care as soon as possible.

Do not apply ingenol mebutate gel right after taking a shower or less than 2 hours before bedtime. After applying ingenol mebutate gel, avoid doing activities that cause a lot of sweating for at least 6 hours.

To use ingenol mebutate gel, follow these steps:

1. Remove the cap from a new tube of ingenol mebutate gel just before you are ready to use it.
2. Squeeze the gel from the tube onto your fingertip. Use just enough gel to cover the area your doctor has instructed you to treat. One tube contains enough gel to cover a skin area of about 2 inches by 2 inches.
3. Spread the gel evenly over only the skin area you are treating.
4. Wash your hands right away after applying the gel. Be careful not to touch your eyes before you wash your hands. If the area you are treating is on your hands, wash only the fingertip you used to apply the gel.
5. Safely throw away the tube in the household trash after a single use.
6. Allow the treated area to dry for 15 minutes. Do not wash or touch the treated area for at least 6 hours. Be careful not to get the gel on the skin of another area of your body or to touch another person with the treated area.
7. Do not cover the treated area with bandages or other dressings.
8. After 6 hours, the treated area can be washed with mild soap and water.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and instructions for use.

What SPECIAL PRECAUTIONS should I follow?

Before using ingenol mebutate gel,

• tell your doctor and pharmacist if you are allergic to ingenol mebutate, any other medications, or any of the ingredients in ingenol mebutate gel. Ask your pharmacist or check the manufacturer's information for the patient for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any other treatments for actinic keratosis.

• tell your doctor if you have other skin problems, including side effects from other treatments or sunburn, in the area you will be treating. You should not use ingenol mebutate gel until your skin has healed.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using ingenol mebutate gel, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Ingenol mebutate gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, flaking, scaling, crusting, or swelling of the skin
• pain, itching, or irritation of the treated skin
• irritation of the nose and throat
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• difficulty breathing or swallowing
• feeling faint
• throat tightness
• swelling of the lips or tongue
• rash
• hives
• itching
• eye pain, swelling or drooping of your eyelids, or swelling around your eyes
• blisters, pus, ulcers, or other sores on the skin

Ingenol mebutate gel may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator; do not freeze ingenol mebutate gel.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.