What is Aldara cream used for?

• Aldara cream is a treatment for external genital warts and warts around the anus.
• Aldara cream is also prescribed to treat small non-malignant skin cancers (basal cell carcinomas) and actinic keratoses, which are rough areas of skin caused by sun damage. These skin lesions are usually harmless, but about two percent can turn into a skin cancer (squamous cell carcinoma) if left untreated. Aldara cream is used for non-raised lesions on the face or scalp, in people with a healthy immune system when other treatments are not appropriate.

How does Aldara cream work?

• Aldara cream contains the active ingredient imiquimod 5%, which is a type of medicine called an immunomodulator.
• Imiquimod acts by stimulating the body's own defence mechanisms. It's thought that it works by binding to immune cells in the skin, causing them to release natural defence chemicals called cytokines. Cytokines help fight viral infections by preventing viruses from multiplying in cells. They also prevent abnormal or malignant cells from increasing in numbers.
• Superficial (non-malignant) skin cancers occur when certain skin cells multiply in an abnormal and uncontrolled way. Aldara cream stimulates the immune cells in the skin to attack the abnormal cells, which shrinks the cancerous growth.
• Actinic keratoses are rough areas of skin caused by sun damage over many years, eg from sunbathing or using sunbeds, or working outdoors. They occur in fair-skinned people, whose skin is particularly sensitive to the damaging effect of UV rays. Aldara cream stimulates the body to attack the abnormal or damaged skin cells.
• Genital warts are caused by the human papilloma virus (HPV). Aldara cream stimulates the immune cells in the skin to attack the virus, which clears up the warts.

Key facts about Aldara cream

• Aldara cream is only suitable for adults aged 18 years and over.
• You apply the cream to the affected area before going to bed and wash it off in the morning. It needs to be left on for 6 to 10 hours for genital warts and 8 hours for basal cell carcinoma or actinic keratoses.
• You apply Aldara cream three times a week for genital warts or actinic keratoses, and five times a week for basal cell carcinoma. Follow the instructions below.
• If you're treating genital warts, be aware that Aldara cream can damage condoms and diaphragms, making them less effective at preventing pregnancy and STIs. It's best to avoid having sex while you're treating genital warts.
• If you're treating basal cell carcinoma or actinic keratoses, protect the treated skin from sunlight with clothing and a wide brimmed hat when outdoors. Do not use sunbeds or sunlamps.
• While you're using Aldara cream, the treated area is likely to look noticeably different to your normal healthy skin until it has healed.
• The most common side effects are itching, redness, irritation, burning sensation or pain where you apply the cream.

Who shouldn't use Aldara cream?

• Aldara cream can be used by most adults but is not suitable for children and adolescents under 18 years of age.
• The cream should not be used to treat genital warts that are inside the vagina, cervix , urethra or anus.

Some people might need extra monitoring while using Aldara cream. Make sure your doctor knows if you:

• are pregnant or breastfeeding
• have an inflammatory skin condition
• have an autoimmune condition (where your immune system attacks the body's own tissues) such as systemic lupus erythematosus
• have had an organ transplant
• are taking immunosuppressant medicines
• have a weak immune system
• are HIV positive
• have low levels of one or more types of blood cells in your blood.

How do I use Aldara cream?

It's important to follow the instructions given by your doctor, as well as those printed in the information leaflet supplied with the cream. Each sachet of cream is for single-use only; do not re-use a sachet once you have opened it.

Do's and don'ts:

• Before each application, wash your hands and the area of skin you are going to treat with mild soap and water and dry thoroughly. Wash your hands again after applying the cream.
• Don't apply the cream to broken, inflamed or normal healthy skin and take care to avoid getting it in contact with your eyes, lips and nostrils.
• Don't cover the treated area with dressings or bandages.
• After you've applied the cream, don't shower or bathe until it's time to wash the cream off.
• DO remember to remove the cream with mild soap and water after the treatment time is up. Applying an excessive amount of cream, or leaving it on too long can cause a severe skin reaction.
• If you forget to apply the cream before going to bed, just leave out that dose and apply your next dose the following bedtime. Don't apply the cream twice in one day to make up for a forgotten application.
• If you get a severe skin reaction that causes you discomfort, do remove the cream by washing the area with mild soap and water. On rare occasions, skin reactions may be accompanied by flu-like symptoms such as fever, nausea or aches and pains. If necessary, you can take a rest period of several days before starting treatment again.
• If you get an infection at the application site do see your doctor so it can be treated. If necessary, you can take a rest period of several days before starting the treatment again.

For warts on the genitals and around the anus:

• Apply Aldara cream in a thin layer to the warts and rub it in until it vanishes, three times a week (for example Monday, Wednesday, Friday) before going to bed. The cream should be left on for 6 to 10 hours each time and then washed off with mild soap and water. Continue treatment until the warts are cleared (up to a maximum of 16 weeks per episode of warts).
• Do not apply the cream to warts that are inside the vagina, anus or urethra.
• Uncircumcised men treating warts under the foreskin should pull back the foreskin and wash the area daily to avoid constriction of the foreskin (phimosis). If you have any trouble pulling back your foreskin during treatment, or you get skin reactions such as redness, ulceration or hardening of the skin, stop using Aldara and see your doctor.

For basal cell carcinomas:

• Apply enough cream to cover the treatment area, including one centimetre of skin surrounding the tumour, and rub it in until it vanishes. Do this five times a week (for example Monday to Friday) before going to bed. The cream should be left on for 8 hours each time and then washed off with mild soap and water. Continue treatment for 6 weeks. 12 weeks after the treatment is finished your doctor will reassess the cancer. If it has not fully responded a different treatment will be used.

For actinic keratoses:

• Apply sufficient cream to cover the treatment area and rub it in until it vanishes. Do this three times a week (for example Monday, Wednesday, Friday) before going to bed. Leave the cream on for 8 hours each time, then wash it off with mild soap and water. The treatment is continued for 4 weeks and you then have a 4 week treatment-free period before your doctor reassesses your skin. If any actinic keratoses remain you will be prescribed one more 4 week course of treatment. Each treatment period should not last for longer than 4 weeks, even if you have had missed doses or rest periods in those 4 weeks.

What are the side effects of Aldrara cream?

Medicines and their possible side effects can affect people in different ways. The following are some of the side effects that may be associated with Aldara cream. Just because a side effect is stated here doesn't mean that all people using this cream will experience that or any side effect.

• Itching, irritation, pain or burning at application site.
• Redness and inflammation of skin at application site.
• Erosion, flaking or swelling of the skin at the application site.
• Scabbing and crusting of skin at application site.
• Tingling sensations at the application site.
• Ulceration at site of application.
• Hair loss around the application site.
• Increase or decrease in skin pigmentation at application site - this may be permanent.
• Headache.
• Flu-like symptoms.
• Aching muscles or joints.
• Infections.
• Swollen glands.
• Nausea.
• Difficulty or pain urinating in women treated for genital warts. See your doctor if you experience this.

Read the leaflet that comes with your medicine or talk to your doctor or pharmacist if you want any more information about the possible side effects of Aldara cream.

Can I use other medicines with Aldara cream?

• Always check with your doctor or pharmacist before using any other medicines on the same area of skin as Aldara cream.
• Imiquimod is only absorbed through the skin into the bloodstream in very small amounts, so it's unlikely to affect any medicines that you take by mouth or injection.

However, as imiquimod stimulates the immune system, the manufacturer states that Aldara should be used with caution in people who are taking medicines to suppress the immune system (immunosuppressants), for example following an organ transplant or to treat an autoimmune disease, because there is the possibility that it could make these medicines less effective.

References:

https://www.rxlist.com/aldara-side-effects-drug-center.htm

https://www.netdoctor.co.uk/medicines/skin-hair/a6163/aldara-cream-imiquimod/

https://www.medicines.org.uk/emc/product/823/smpc

https://www.webmd.com/drugs/2/drug-1207/aldara-topical/details

https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/imiquimod

https://chealth.canoe.com/drug/getdrug/aldara

https://www.myvmc.com/drugs/aldara/