Ingenol Mebutate Topical

Dosage Forms & Strengths

topical gel

• 0.015% (3 unit dose tubes/carton)
• 0.05% (2 unit dose tubes/carton)

Actinic Keratosis

Indicated for topical treatment of actinic keratosis

Face or scalp: Apply 0.015% gel to affected area qDay for 3 consecutive days; avoid application in, near, and around the eyes, in the mouth, and on the lips

Trunk or extremities: Apply 0.05% gel to affected area qDay for 2 consecutive days

Do not apply gel to more than 1 area simultaneously

Only be used on 1 contiguous skin area not exceeding ~25 cm² (5 cm × 5 cm)

Not for spot treatment of actinic keratosis on multiple application sites simultaneously that exceeds 25 cm²

Actinic keratosis is not a condition generally seen within the pediatric population

<18 years: Safety and efficacy not established

In clinical trials, 56% of participants were 65 years or older, and 21% were 75 years or older

No differences in safety or effectiveness were observed between elderly and younger participants

>10%

Face/scalp application

• Erythema (94%)
• Flaking/scaling (85%)
• Crusting (80%)
• Swelling (79%)
• Vesiculation/pustulation (56%)
• Erosion/ulceration (32%)
• Application site pain (15%)

Trunk/extremities application

• Erythema (92%)
• Flaking/scaling (90%)
• Crusting (74%)
• Swelling (64%)
• Vesiculation/pustulation (44%)
• Erosion/ulceration (26%)

1-10%

Face/scalp application

• Application site pruritus (8%)
• Application site infection (3%)
• Periorbital edema (3%)
• Headache (2%)

Trunk/extremities application

• Application site pruritus (8%)
• Application site irritation (4%)
• Nasopharyngitis (2%)
• Application site pain (2%)

Frequency Not Defined

Eyelid edema

Eye pain

Chemical conjunctivitis

Postmarketing Reports

Allergic contact dermatitis

Herpes Zoster

Corneal burn

Eye injuries

Application site pigmentation changes

Application site scarring

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.

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).

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

Skin redness, itching, irritation, flaking/peeling, crusting, pain, or swelling commonly occur at the site of application. Eye/eyelid, nose, or throat irritation or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blisters, pus, or ulcers at the application site.

Get medical help right away if you have any very serious side effects, including: painful rash (especially on one side of the face or body), vision changes (including increased sensitivity to light, vision loss).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ingenol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin problems (including sunburn) in the treatment area.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.