Picato Gel (Ingenol mebutate) is used for the topical treatment of actinic keratosis or sun spots. It is a rough scaly patch of skin that usually develops in sun-exposed areas of the body.

Picato Gel (Ingenol mebutate) Uses:

• Actinic keratosis:

  • Actinic keratosis topical therapy is advised for it. 

Adults that use Picato Gel:

Dosage of Picato Gel (Ingenol mebutate) for Actinic Keratosis: 
Topical:

• Face or scalp:

  • For three days straight, apply 0.015 percent gel once per day to the affected area. 

  • If a patient's condition does not improve or returns 8 weeks or more after the first round of treatment, they might require a second round of therapy. 
     

  Limbs or the trunk:

  • For two days in a row, apply 0.05 percent gel once daily to the affected area.

Dose in Children:

Not indicated.

Pregnancy Risk Factor C

• In animal pregnancy studies, adverse fetal outcomes were observed following injections.
• However, topical applications are not likely to absorb and can be used during pregnancy.

Ingenol mebutate use during breastfeeding:

• It is unknown if the drug will be excreted into breast milk.
• The drug is absorbed minimally through the skin after topical application.

Dose in Kidney Disease:

In the manufacturer's labeling, dosage adjustments have not been provided. However, since the drug is minimally absorbed, dosage adjustment is unlikely.

Dose in Liver disease:

In the manufacturer's labeling, dosage adjustments have not been provided. However, since the drug is minimally absorbed, dosage adjustment is unlikely.

Common Side Effects of Picato Gel (Ingenol mebutate):

• Dermatologic:

  • Erythema
  • Desquamation
  • Exfoliation Of Skin
  • Crusted Skin
  • Swelling Of Skin
  • Localized Vesiculation
  • Pustules
  • Dermal Ulcer
  • Skin Erosion
  • Application Site Pain

Less Common Side Effects of Picato Gel (Ingenol mebutate):

• Central nervous system:

  • Headache

• Ophthalmic:

  • Periorbital edema

• Dermatologic:

  • Application-related itching
    application-site discomfort
    Skin disease

• Respiratory:

  • Nasopharyngitis

Frequency of side effects not defined:

• Ophthalmic:

  • Conjunctivitis
  • Eyelid edema
  • Eye pain

Contraindications to Picato Gel (Ingenol mebutate):

Allergy reactions to ingenol mebutate and any component of this formulation

Warnings and precautions

• Dermatologic reactions

  • Erythema and crusting, swelling, vesiculation, pustulation, erosion, and ulceration are a few examples of severe skin reactions that might happen.

• Hypersensitivity

  • It is possible to experience hypersensitivity reactions including severe reactions like anaphylaxis or allergic contact dermatitis.
  • If the patient experiences severe allergic reactions, it is imperative that the treatment be stopped immediately and that appropriate steps are taken.

• Ocular:

  • Avoid contact with the eyes or periocular region. Some patients may experience severe pain, chemical conjunctivitis, and edema of their eyelids.
  • After using the medication, patients should promptly wash their hands. If exposure happens accidentally, wash the area with water.
  • A healthcare provider may be necessary for the patient to receive treatment.

Monitoring Parameters:

Monitor the response to therapy.

How to administer Picato Gel (Ingenol mebutate)?

Using one unit-dose tube, the gel is topically administered to one contiguous area of the skin that is afflicted. A unit-dose tube should cover an area of approximately 5 cm by 5 cm (25 cm2 or 2 in x 2 in).

The damaged region should have the gel applied evenly, and it should then have 15 minutes to dry. Bandages or occlusive dressings shouldn't be applied to the area.

When the gel is applied, hands must be washed immediately to avoid contact with other skin areas, especially the eyes. The treatment area should not be touched or washed for at least six hours.

After a period of six hours, the area may be washed with a mild soap gently. It should not be used inside the oral cavity, inside or around the eyes, or inside the vagina. The oral cavity and perioral area should not get exposed to the gel.

Mechanism of action of Picato Gel (Ingenol mebutate):

Ingenol mebutate causes necrosis in actinic Keratosis. This is followed by antibody-dependent cytotoxicity and neutrophil-mediated inflammation response. The death of any remaining cells will prevent future relapse.

Absorption:

• When used properly, it is only minimally absorbed through the skin.
• The systemic exposure expected is 0.1ng/mL

International Brand Names of Ingenol mebutate:

• Picato

Ingenol mebutate brand names in Pakistan:

No Brands Available in Pakistan.