Instructions for the application of topical Aldara (5% Imiquimod)

What is Aldara?

Aldara is a cream containing the active ingredient imiquimod (5%). This ingredient is active
against anogenital pre-cancerous lesions called high-grade squamous intraepithelial lesions
(HSIL). Treatment with Aldara for HSIL is considered to be “oD-label.” This means that it is being
prescribed for a condition or in a manner not included in the original studies used for regulatory approval, but studies have shown this to be an eDective treatment for patients.

The cream works by stimulating the immune system in the aDected tissue, which can result in the resolution of HSIL.

Aldara cream may cure or improve your condition, but it does not work for everybody. If this does not work, we will oDer you alternative treatments such as topical trichloroacetic acid (TCA) or laser ablation.

This treatment may not work if you have a weakened immune system due to a particular health
condition or because you are on medication or treatment that suppresses your immune system.

How should I apply the cream?

1) The cream should be applied into the anus before you go to bed. with a clean fingertip.
You may also be asked to apply Aldara externally to your skin.

2) Apply a third of one sachet of Aldara cream on your clean fingertip and insert 2-3 cm into
your anal canal as directed by your health care professional. This should be applied three
times per week at bedtime. For example: Monday, Wednesday and Friday night-time. You
may be asked to apply Aldara externally to your skin.

3) Gently apply the cream all the way around the inside of the anus. Wash oG any cream oG
that may have accidently been applied to the outside skin. Alternatively, you can apply
some petroleum jelly (Vaseline) to the skin around your anus. This stops the Aldara from
spreading to unwanted areas.

4) Wash your hands after application. Avoid your hands coming into contact with other
areas of your skin.

5) If you have applied Aldara to your skin outside the anus, carefully wash the treated skin
with water at least of eight hours after application. Avoid further spreading of the cream
by washing flannels after use or using disposable tissues or cotton wool.

6) Apply a moisturiser twice a day to the aGected area, but not within eight hours of applying
Aldara. This willsoothe the treated skin. We recommend Hydromol ointment, Cetraben cream or Doublebase.

7) Avoid using soaps and shower gels on or near your genitals during the treatment period
as they may irritate your skin. You can use a moisturiser as a soap substitute.

8) Flamazine cream applied once daily which can help with any soreness you may
experience.

Apply imiquimod 5% cream once a night, 3 times a week for 12-16 weeks. Reduce the dose to twice a week if you experience significant irritation.

What are the side effects of Aldara cream?

It may take time for Aldara to be effective. The skin reaction is often worse in the 3rd week of
application.

The affected area can become red, swollen and sore within 5 days of starting treatment.

Some patients may experience their skin peeling, cracking, blistering and then a scab forming. You may experience itching, burning or stinging. This is due to inflammation caused by Aldara.

Inflammation is a good sign, as it shows the cream is working, although this may cause discomfort/side eGects. In general, the more intense the inflammation, the better the result. Surrounding skin may also become inflamed, but this will settle when you stop using the cream. The skin redness can take up to 4 weeks to subside once treatment is stopped.

If the affected area becomes too uncomfortable, take a break from using the cream for a week and then re-start treatment if the skin is better. You can also reduce treatment down to 2 applications a week.

Allergic reactions are rare. There is a risk of infection, ulceration, scarring, a flare-up of other pre-existing autoimmune conditions and development of flu-like symptoms. These are uncommon.

Please let us know if you have severe side-effects, concerns or if you need any advice.

Please let us know if:
• you are planning on getting pregnant
• you are breast feeding

Please note that Aldara is a brand name for 5% Imiquimod. There are other brands available and in the event of supply chain disruptions with Aldara, we may need to supply you with an alternative brand of the same medication.

References: Brogden, Danielle RL, et al. "Evaluating the efficacy of treatment options for anal intraepithelial neoplasia: a systematic review." International Journal of Colorectal Disease 36 (2021): 213-226.