Please read this information carefully before beginning treatment with 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream. You can access this information again by scanning the QR code or visiting the web address you were given with this medicine. For a paper copy, contact Artisan Chemist. You may also save this webpage as a bookmark or favourite in your internet browser, or print it out on paper or as a PDF.
The following information answers common questions about 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream. It does not contain all available information. It should not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of treatment with this medicine against the benefits it is expected to have for you.
If you have any concerns about using 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream, talk to your doctor or pharmacist.
What it does
5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream is used to treat solar keratoses (also called actinic keratoses or sunspots).
Solar keratoses are red, rough, scaly or crusty spots on the skin caused by exposure to sunlight. They are more common on areas exposed to the sun, such as the face, nose, ears, back of the hands, forearms, chest and scalp. Solar keratoses are usually harmless, however there is a small risk they may eventually develop into skin cancer.
Ask your doctor if you have any questions about why 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream has been prescribed for you. Your doctor may have prescribed it for another reason.
How it works
5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream contains two active ingredients; 5-fluorouracil and calcipotriol.
5-fluorouracil is an anti-cancer medicine used in topical treatments for solar keratoses and Bowen’s disease (a type of skin cancer). It is the active ingredient in the cream “Efudix®”. It works by destroying precancerous and cancerous cells.
5-fluorouracil is cytotoxic. This means it is toxic to living cells, preventing their replication and growth. Cytotoxic medicines are useful to treat conditions where cells are not growing in a normal way, but they can be dangerous to healthy cells as well. It is very important that you handle, store and dispose of this medicine carefully to avoid untreated areas and reduce the risk of unwanted side effects.
Calcipotriol is a medicine similar to vitamin D, and used in topical treatments for skin disorders such as psoriasis. It is the active ingredient in the cream “Daivonex®”. It works by treating overactive skin cells.
Recent clinical studies have found that a combination of 5-fluorouracil and calcipotriol reduces the number of solar keratoses, and may protect against further skin cancer development.
When you must not use this medicine
Do not use this medicine if:
- you have an allergy to any medicines which contain 5-fluorouracil, calcipotriol, or any other ingredients listed in the Product Information section of this webpage – signs of an allergic reaction include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin
- you have dihydropyrimidine dehydrogenase (DPD) deficiency
- you have high blood calcium levels
- you are taking calcium, vitamin D supplements or vitamin D-like medicines (e.g. calcitirol)
- you are pregnant or planning to become pregnant – it may affect your developing baby if you use it during pregnancy
- it is expired or the container is damaged – the expiry date will be on the pharmacy label; for disposal, see Storage and Disposal
If you are not sure whether you should start using 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream, talk to your doctor.
Before you start to use this medicine
Tell your doctor if you:
- have inflammatory skin conditions such as darkening of skin during pregnancy (chloasma) or a chronic rash (rosacea)
- have kidney or liver problems
- have any other health problems or illness
- are breastfeeding or intend to breastfeed – it is not known if the active ingredients pass into breast milk and if there is a possibility that your baby may be affected
- work outside for long periods of time during the day – this medicine is not recommended for people who are unable to avoid sun exposure
If you have not told your doctor about any of the above, tell them before you use 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you bought from a pharmacy, supermarket or health food shop. Some medicines and 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream may interfere with each other.
Follow all directions given to you by your doctor or pharmacist. They may be different from the directions given on this webpage.
This medicine is cytotoxic. It is very important that you handle, store and dispose of this medicine carefully to reduce the risk of unwanted side effects.
How to use this medicine
Follow these steps:
- Wash your hands thoroughly.
- Wash the skin to be treated using lukewarm water only. Avoid soap or other cleansing products which may sting or irritate your skin, especially as treatment progresses.
- Pat dry the treatment area(s) with a soft white paper towel.
- Allow 15 minutes for your skin to completely dry.
- Put on disposable rubber gloves.
- Remove the protective cap from the syringe or jar.
- Take care when dispensing the cream, press gently to dispense only the amount you need.
- Apply a thin layer of cream to the affected area(s) with a disposable rubber glove, cotton tip or non-metal applicator. Do not use too much cream.
- Place used cotton tips, applicators and gloves into a plastic bag, taking care not to touch any cream left on these items. Seal the bag and store it until it can be disposed of safely; see Storage and Disposal.
- Replace the protective cap on the syringe or jar.
- Wash your hands thoroughly immediately after applying the cream.
- Do not cover the treated area unless advised by your doctor. If your doctor asks you to apply a dressing, apply a fresh dressing to the treated area(s) daily.
- Be very careful not to allow the cream to come into contact with mucous membranes (e.g. eyes, eyelids, nostrils, lips).
- Do not apply to broken skin or open cuts as the medicine may be absorbed into the bloodstream and may cause side effects.
When to use this medicine
Apply 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream once or twice daily as advised by your doctor. Apply the cream at about the same time each day, in the morning and then again in the late afternoon or early evening.
Do not apply the cream immediately before going to bed. Apply at least 1.5 - 2 hours before bedtime to enable complete absorption and prevent wiping off onto pillowcases and sheets. Contact with pillowcases or sheets may result in undesirable spreading of the cream to normal skin that does not need treatment.
How much to use
The total area of skin treated with this cream at any time should not exceed 500 square cm (approx. 23 x 23cm). Larger areas should be treated a section at a time.
How long to use this medicine
Use 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream only for the length of time your doctor has told you. Do not continue further treatment unless advised by your doctor.
If you forget to use this medicine
Do not try to make up for the application you missed by applying more at the next application time. If you are not sure what to do, ask your doctor or pharmacist.
If you use this medicine too much (overdose) or use it other than directed
If this cream is swallowed, enters the eyes, nose or mouth, or if you or anyone else may have used too much cream, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26) for advice, or go to the Emergency Department at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are using this medicine
Expect the treatment area(s) to look worse and feel uncomfortable while treatment is in progress. It may take several weeks after treatment before you see improvement in your condition. You may notice redness, blistering, peeling, cracking or flaking, with occasional open sores and discomfort. Redness can persist for some time after treatment has ended.
You must limit your exposure to sun during and immediately after treatment. This medicine can make you more sensitive to sunlight; too much sun exposure can cause unwanted side effects. Always apply broad spectrum sunscreen (SPF 30 or higher) before going outside and regularly reapply, do not use sunscreen directly on treatment area(s). Wear protective clothing (e.g. long sleeves, wide-brimmed hat) and stay in the shade as much as possible.
Tell any health professionals that treat you (e.g. doctors, pharmacists, dentists) that you are using this medicine. If you are about to be started on a new medicine, remind your doctor and pharmacist that you are using this medicine.
If you become pregnant or suspect you may be pregnant, stop using this medicine and tell your doctor immediately.
Keep regular appointments with your doctor so that your progress can be checked. Always discuss with your doctor any problems or difficulties you experience during or after treatment with 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream.
You must not:
- give this medicine to anyone else, even if they have the same condition as you
- use this medicine on other areas, or to treat different complaints, without checking with your doctor
- stop treatment or change the dose without checking with your doctor
- let this medicine come into contact with the eyes, eyelids, nostrils or mouth
Avoid using cosmetics or other topical medicines, including sunscreens, directly on the treatment area(s) unless directed by your doctor.
You may continue to shave whilst using this medicine, but take care not to cut your skin in the treatment area(s). If your skin is inflamed, you may prefer to lightly shave with an electric razor or clip hair with scissors instead of using a conventional razor.
Tell your doctor or pharmacist as soon as possible if you do not feel well during or after treatment with 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream.
As with all medicines, this cream may cause unwanted side effects. The most common side effects usually do not last long, are usually limited to the treatment area(s), and are also a sign that the medicine is working. They include:
- soreness and pain
- skin irritation (including rashes or peeling)
- redness, lightening or darkening of the skin
- burning, stinging
- weeping, crusting
- increased sensitivity of the skin to the sun
- allergic contact dermatitis
Tell your doctor or pharmacist if any of the above side effects become too uncomfortable for you.
Tell your doctor immediately if you experience severe pain or ulceration at the site of application.
Stop treatment immediately and contact your doctor if you experience any of the following:
- stomach problems (e.g. severe pain, cramps, bloody diarrhoea, vomiting)
- swelling and soreness of the mouth and tongue
- fever and chills
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
Some people may experience side effects that are not listed above. Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you have any questions about the side effects of 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream.
How to store
Store all medicines out of the reach of children or pets.
Keep this medicine in a cool dry place where the temperature stays below 25°C. Protect from direct sunlight or heat. Do not store this cream or any other medicines in the bathroom or near a sink. This cream can be stored in the fridge.
How to dispose of this medicine
5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream is cytotoxic, so must not be disposed of at home. If you have unused or expired cream, or any disposable items that have come into contact with the cream (e.g. cotton tips, applicators, gloves), bring them in a sealed plastic bag to your local community pharmacy for safe disposal.
Do not flush unused medicines down the toilet, or pour them down a sink or drain.
What it looks like
Artisan Chemist 5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream is a soft, white cream that comes in the following packaging:
- 5g syringe
- 10g syringe
- 30g pink EMP (Electronic Mortar and Pestle) jar
- 50g blue EMP jar
- 100g white and red EMP jar
5-Fluorouracil 5% Calcipotriol 0.005% Topical Cream contains the active ingredients 5-fluorouracil and calcipotriol. It also contains:
- Dimethyl sulfoxide
- HRT cream base (with Vitamin E and Aloe Vera)
This medicine does not contain lactose, sucrose or gluten. HRT cream base is free of alcohol, petrolatum, parabens and oil; it is proven hypoallergenic through HRIPT.
Efudix is a registered trademark of iNova Pharmaceuticals (Singapore) Pte Limited.
Daivonex is a registered trademark of LEO Pharma A/S, Denmark.
- MIMS Online [Internet]. St Leonards (NSW): MIMS Australia; 2018 Feb. Efudix (Fluorouracil); [prepared 2017 Nov; cited 2021 Jul 20]. Available from: https://www-mimsonline-com-au.ap1.proxy.openathens.net
- NPS MedicineWise [Internet]. Surrey Hills (VIC): NPS MedicineWise; 2014 Oct. Daivonex cream (Calcipotriol); [updated 2012 Jul; cited 2021 Jul 20]. Available from: https://www.nps.org.au/medicine-finder/daivonex-cream
- Australian Medicines Handbook [Internet]. Adelaide (SA): Australian Medicines Handbook Pty Ltd; 2021. Fluorouracil (skin); [updated 2021 Jul; cited 2021 Jul 20] Available from: https://amhonline-amh-net-au.ap1.proxy.openathens.net/chapters/dermatological-drugs/drugs-actinic-keratoses/fluorouracil-skin
- Cunningham TJ, Tabacchi M, Eliane JP, et al. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest [Internet]. 2017 [cited 2021 Jul 21];127(1):106-16. Available from: https://www.jci.org/articles/view/89820. doi: 10.1172/JCI89820
- Rosenberg AR, Tabacchi M, Ngo KH, et al. Skin cancer precursor immunotherapy for squamous cell carcinoma prevention. JCI Insight [Internet]. 2019 Mar 21 [cited 2021 Jul 21];4(6):e125476. Available from: https://insight.jci.org/articles/view/125476. doi:10.1172/jci.insight.125476
- Medisca. HRT CREAM BASE (For Women) [Internet]. Saint-Laurent (QC): Medisca Inc.; Publication date unknown [cited 2021 Jul 22]. Available from: https://www.medisca.com/Pages/ProductDetails.aspx?StockCode=0701&C=B&C2=108