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The content of this webpage is for Australian healthcare professionals only.

ACTIKERALL

ACTIKERALL is a topical solution that contains two active ingredients, 0.5% 5-fluorouracil (5-FU) and 10% salicylic acid.1

It is used to treat actinic keratosis (also called solar keratosis), a skin condition characterised by small crusty, scaly or crumbly patches of skin.

 Once daily1

 Penetrates thick lesions2-4

  Targeted application1

 

What is Actinic Keratosis?1

Actinic keratoses (AK) or Solar keratoses are rough, red, scaly, or crusty spots on the skin that are caused by too much exposure to sunlight. They are more common on sun-exposed areas, such as the face, nose, ears, chest, forearms, and back of the hands.
 

Actinic keratoses are usually harmless, but there is a risk that they may turn into skin cancer.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. 

ACTIKERALL Leisions
Picture courtesy of Almirall S.A.

How to apply ACTIKERALL

The application of Actikerall is a simple procedure that can be done in 3 steps:
 
STEP 1
STEP 1
  • To open, press the lid down and turn.*
  • Wipe off the excess solution from the applicator in the neck of the bottle.*Bottle has a childproof lid.
STEP 2
STEP 2
  • For lesion (spot) directed treatment:   Dab the solution directly on the spot being treated, and up to a maximum of 0.5 cm of healthy skin surrounding it.
  • For field (wider area your doctor has described) directed treatment: Dab the solution on the affected area, not exceeding 25 cm2 (5 cm x 5 cm).
STEP 3
STEP 3
  • Let the solution dry to form a film.
  • Before the next application, remove the existing film by peeling it off.
Pictures courtesy of Almirall S.A.

Things to remember1

Actikerall animated bottle
 
Close the bottle tightly to prevent it from drying out.
Actikerall Hand applicator
 
After application, do not cover lesion(s) with a dressing until the solution is dry.
Actikerall warm water
 
Using warm water, mineral oil, or rubbing alcohol may help you to remove the film from the previous day’s application. 5
Actikerall applicator vector
 
If you forget one application, do not use a double dose to make up for it.
  • ACTIKERALL should not be applied to hairy skin* as the hair becomes stuck together in the affected area.
  • When applied to hairy skin, a shave or other suitable methods of hair removal should be considered prior to any application of ACTIKERALL.

*Use only on the face, forehead or bald scalp (excluding eyelids, lips and mucosa). 

What to expect during
treatment with ACTIKERALL

Treated areas are likely to become swollen, red and sore. This is part of the process and shows that the product is working.

 aCTIKERALL before and after
Picture courtesy of Almirall S.A.

Ask your doctor or pharmacist if you have any concerns about this treatment.

▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get to your doctor, or directly at www.tga.gov.au/reporting-problems .
 
WARNING: Actikerall® is intended for use only on mild and moderate solar keratosis. Actikerall® should not be applied on a total area greater than 25 square centimetres (cm2) at any one time. Use Actikerall® only on the face, forehead, or bald scalp. Do not use Actikerall on eyelids, lips, or mucous membranes.
AK = Actinic Keratosis
References
1. ACTIKERALL Consumer Medicine Information 2023. 2. ACTIKERALL Product Information. 3. Stockfleth E, et al . Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol . 2011;165(5):1101-8. 4. Simon JC, et al . A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol . 2015;29(5):881-9. 5. Martínez N, et al . Alternative lacquer removal techniques to remove 0.5% 5-fluorouracil/10% salicylic acid topical solutions for actinic keratosis. Presented at 14th EADO Congress; 6-9 November; Barcelona, Spain. 2018. 6. https://www.cancervic.org.au/cancer-information/types-of-cancer/skin_cancers_non_melanoma/skin-cancer-overview.html [ accessed on 01 May 2023]. 7. British Association of Dermatologists, Patient Information Lea­flet Actinic Keratosis 2020, accessed from https://www.skinhealthinfo.org.uk/wp-content/uploads/2018/11/Actinic-Keratoses-Update-Dec-2020-Lay-reviewed-Oct-2020.pdf [accessed on 01 May 2023].
 
ACTIKERALL® is a registered trademark of Almirall S.A.
ACTIKERALL is distributed by Mayne Pharma International Pty Ltd under licence from Almirall Hermal GmbH. ACT0021. Date of preparation: May 2023
 
 
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