Picato

Picato is part of the drug class:

• Other chemotherapeutics

No Picato drug interactions have been identified, however, you should tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are being treated for actinic keratosis with surgery or other medications. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Picato there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Picato falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Administration

Topical Administration

Apply topically as a 0.015 or 0.05% gel.1

For external use only.1 Do not administer orally, vaginally, or topically to the lips or eyes.1 9

FDA has received reports of severe eye injuries and skin reactions associated with the application of the drug; some cases were associated with application of the gel jn a manner other than that recommended in the product labeling.9 (See Cautions: Warnings/Precautions and see Advice to Patients.)

Apply evenly to affected area, up to one contiguous area of skin approximately 25 cm2.1 Wash hands immediately after applying ingenol mebutate gel.1

Allow gel to dry for 15 minutes; avoid washing or touching the treated area for 6 hours after application.1 After 6 hours, may wash area with a mild soap.1

Dosage

Adults

0.015% Gel: Apply evenly to affected area once daily for 3 consecutive days.1

0.05% Gel: Apply evenly to affected area once daily for 2 consecutive days.1

Prescribing Limits

Adults

Use only enough gel to cover the treatment area (≤1 single-use tube per application); do not use more often or for longer than instructed.1

• Tell all of your health care providers that you take Picato. This includes your doctors, nurses, pharmacists, and dentists.
• If you get this medicine 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 this medicine 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 this medicine is swallowed, call a doctor or poison control center right away.
• People using Picato may have skin reactions where this medicine 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 this medicine 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 or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 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.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take Picato or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Picato. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Picato®  gel is contraindicated in patients with known hypersensitivity to ingenol mebutate or any component of the formulation. Anaphylaxis, as well as allergic reactions leading to hospitalization have been reported in postmarketing use with Picato® gel [see Adverse Reactions (6.2)] .

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemic embryofetal development studies were conducted with ingenol mebutate in rats and rabbits. Intravenous doses of 1.5, 3, and 5 µg/kg/day (9, 18, and 30 μg/m2/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 – 16) to pregnant female rats. No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses up to 5 µg/kg/day (30 μg/m2/day). Intravenous doses of 1, 2, and 4 µg/kg/day (12, 24, and 48 μg/m2/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. An increase in embryo-fetal mortality was noted at 4 µg/kg/day (48 μg/m2/day). An increased incidence of fetal visceral and skeletal variations was noted in all three ingenol mebutate dose groups. The clinical relevance of these findings is unclear since systemic exposure of ingenol mebutate was not detected in subjects with actinic keratosis treated with Picato® gel, 0.05% applied to a 100 cm2 treatment area [see Clinical Pharmacology ( 12.3)].

8.4 Pediatric Use

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.

8.5 Geriatric Use

Of the 1165 subjects treated with Picato® gel in the clinical trials, 56% were 65 years and older and, 21% were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Picato® gel or ingenol mebutate. The effects of ingenol mebutate on fertility have not been evaluated.

Ingenol mebutate was negative in the Ames test, in vitro mouse lymphoma assay, and in vivo rat micronucleus test, but positive in the Syrian hamster embryo (SHE) cell transformation assay.

Common side effects of Picato include: dermal ulcer, localized vesiculation, skin erosion, swelling of skin, and erythema. See below for a comprehensive list of adverse effects.

Applies to ingenol topical: topical gel

General

The most commonly reported side effects were local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/postulation, and erosion.[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Local

Very common (10% or more): Application site erythema (up to 94%), application site exfoliation (up to 90%), application site scab (up to 80%), application site swelling (up to 79%), application site erosion/ulceration (up to 32%), application site vesicles (up to 20%), application site pain (including application site burning) (up to 15%)
Common (1% to 10%): Application site pruritus, application site irritation
Uncommon (0.1% to 1%): Application site discharge, application site paresthesia, application site ulcer, application site warmth[Ref]

Dermatologic

Very common (10% or more): Flaking/scaling (85%), crusting (80%), vesiculation/postulation (56%)
Postmarketing reports: Allergic contact dermatitis[Ref]

Immunologic

Very common (10% or more): Application site pustules (up to 43%)
Common (1% to 10%): Application site infection
Postmarketing reports: Herpes zoster[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Ocular

Common (1% to 10%): Eye lid edema, periorbital edema
Uncommon (0.1% to 1%): Eyelid pain
Frequency not reported: Chemical conjunctivitis, corneal burn, eyelid ptosis[Ref]

Other

Very common (10% or more): Swelling (79%)[Ref]

Some side effects of Picato may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.