Generic drug: ingenol mebutate
Brand name: Vantas
What is Vantas (ingenol mebutate), and how does it work?
- Picato gel, 0.015% is a prescription medicine used on the skin to treat actinic keratosis on the face or scalp.
- Picato gel, 0.05% is a prescription medicine used on the skin to treat actinic keratosis on the body or arms and legs.
It is not known if Picato gel is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.
What are the side effects of Vantas?
Picato gel may cause serious or severe side effects including:
- Eye problems can happen if Picato gel gets in your eyes. Eye problems may include severe eye pain, swelling or drooping of your eyelids, or swelling around your eyes. If you accidentally get Picato gel in your eyes, flush them with large amounts of water and get medical care as soon as possible.
- Serious allergic reactions. Serious allergic reactions have happened with Picato gel, and in some cases have required treatment in a hospital. See “Who should not use Picato gel?”. Get medical help right away if you get any of the following symptoms of a serious allergic reaction:
- swelling of the lips or tongue
- trouble breathing or wheezing
- chest tightness
- dizziness or passing out
- Local skin reactions. Skin reactions in the treatment area are common with Picato® gel. You may get a skin reaction such as mild redness, flaking or scaling, crusting, or swelling. You may also see changes in your skin color (pigmentation changes) and scarring where Picato gel is applied. Call your healthcare provider if you get skin redness, flaking or scaling, crusting, or swelling that is more severe, or if you get blisters, pus, ulcers or breakdown of your skin.
The most common side effects with Picato gel include:
- local skin reactions, see “Local skin reactions” above
- pain, itching, or skin irritation at the treatment area
- infection at the treatment area
- swelling around the eyes
- nose and throat irritation
- headache
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Picato gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to LEO Pharma Inc. at 1-877-494-4536.
What is the dosage for Vantas?
- For the treatment of actinic keratosis on the face or scalp Picato gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.
- For the treatment of actinic keratosis on the trunk or extremities Picato gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.
- Picato gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm² (e.g., 5 cm x 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato gel 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 a period of 6 hours after application of Picato gel. Following this time, patients may wash the area with a mild soap.
- Avoid transfer of Picato gel to periocular area.
- Avoid application near and around the mouth and lips.
- For topical use only. Vantas is not for oral, ophthalmic, or intravaginal use.
What drugs interact with Vantas?
No Information provided
Is Vantas safe to use while pregnant or breastfeeding?
- There are no available data on Picato gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- There are no data on the presence of ingenol mebutate in human or animal milk, the effects on the breastfed infant or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Picato gel and any potential adverse effects on the breastfed infant from Picato gel or from the underlying maternal condition.