Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Picato (Ingenol-mebutate).
HEALTH CANADA ADVISORY
October 27, 2020
Health Canada has issued new restrictions concerning the use of ingenol. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Proper use: Picato (Ingenol-mebutate) should only be applied to the skin. Do not apply the gel on the inside of the nostrils, on the inside of the ears, on the lips, or on skin outside the treatment area as defined by your doctor. Make sure that the skin has healed from the other treatments or surgery before applying ingenol. If the gel is accidently applied to these areas, rinse thoroughly with mild soap and water.
If Picato (Ingenol-mebutate) is accidentally swallowed, drink plenty of water and get immediate medical attention.
Eyes: Picato (Ingenol-mebutate) can cause swelling around the eyes and eye lids, eye swelling, eye pain, and a droopy eyelid. If these effects occur, they go way over time without long-lasting effects. Since ingenol can irritate and cause burn injuries to the eyes, avoid getting the gel in the eyes. If the gel does get in the eyes, flush them immediately with large amounts of water, and seek immediate medical attention.
Skin: Skin reactions such as redness, flaking or scaling, crusting, swelling, and blistering or ulceration may occur starting from the first day of treatment and may worsen up to one week after you have finished using ingenol. These will usually get better within 2 weeks from when you started treatment on the face and scalp, and within 4 weeks from when you started treatment on the body, arms, hands and legs. If these reactions do not improve, see your doctor.
Pregnancy: Picato (Ingenol-mebutate) has not been studied in pregnant women. It is recommended to avoid using ingenol during pregnancy.
Breast-feeding: If you are a breast-feeding mother, avoid physical contact between the treatment area and your infant for a period of 6 hours after applying ingenol.
Children: The safety and effectiveness of using Picato (Ingenol-mebutate) have not been established for children under the age of 18 years.