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ingenol mebutate topical (Rx)Brand and Other Names:Picato

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

topical gel

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

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Adverse Effects

>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

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Warnings

Contraindications

Known hypersensitivity to drug or component of formulation

Cautions

Avoid treatment of periocular area; eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure; caution patients to wash hands well after application and avoid transfer of the drug to other areas of the body; if accidental exposure occurs, flush eyes with water and seek medical care

Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/postulation, and erosion/ulceration occurs after topical application

Severe allergic reactions and herpes zoster infection reported; cases describe severe eye injuries and skin reactions, of which some were associated with the gel not being used according to the instructions

Not recommended until skin is healed from any previous drug or surgical treatment

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

The mechanism by which ingenol mebutate induces cell death is unknown

Absorption

Systemic exposure is negligible; blood levels and 2 of its metabolites were below the lower limit of quantification (ie, <0.1 ng/mL)

Metabolism

Ex vivo studies showed extensive metabolism in human hepatocytes

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Administration

Instructions

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

1 unit dose tube covers up to one contiguous skin area of approximately 25 cm² (eg, 5 cm x 5 cm)

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

On the trunk or extremities: Apply 0.05% gel topically to the treatment area qDay for 2 consecutive days

Do not apply gel to more than 1 area simultaneously

After spreading evenly over the treatment area, allow gel to dry for 15 minutes

Patients should wash their hands immediately after application 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 6 hr after; following this time, patients may wash the area with a mild soap

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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