Imiquimod

What it is used for

Imiquimod Cream is a prescription medicine for use on the skin only (topical) to treat:

• actinic keratosis on the face or scalp in adults with a normal immune system. Actinic keratosis is caused by too much sun exposure.

• superficial basal cell carcinoma in adults with a normal immune system when surgery is not recommended.

• Warts on or around the genitals or anus in people 12 years and older.

Imiquimod Cream will not cure your genital or perianal warts. New warts may develop during treatment with Imiquimod Cream. It is not known if Imiquimod Cream can stop you from spreading genital or perianal warts to other people.

It is not known if Imiquimod Cream is safe and effective in:

• people who do not have a normal immune system.

• the treatment of basal cell nevus syndrome.

• the treatment of xeroderma pigmentosum.

• the treatment of actinic keratosis with more than one treatment course in the same affected area.

• the treatment of certain basal cell carcinoma.

It is not known if Imiquimod Cream is safe and effective in children younger than 18 years of age for the treatment of actinic keratosis or superficial basal cell carcinoma. Children usually do not get actinic keratosis or basal cell carcinoma.

It is not known if Imiquimod Cream is safe and effective in children younger than 12 years of age for the treatment of genital and perianal warts.

How to take it

• Do not get Imiquimod Cream in or near your mouth, eyes, nose or vagina.

• Imiquimod Cream exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you where to apply Imiquimod Cream and how often and for how long to apply it for your condition.

• Imiquimod Cream is used for different skin conditions. Use Imiquimod Cream only on the area of your body to be treated. Do not apply Imiquimod Cream to other areas.

• Do not use Imiquimod Cream longer than prescribed. Using too much Imiquimod Cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effect.

• You should follow-up with your healthcare provider regularly for check-ups while using Imiquimod Cream.

• Talk to your healthcare provider if you think Imiquimod Cream is not working for you.

Applying Imiquimod Cream

Imiquimod Cream should be applied just before your bedtime.

• Wash the area where the cream will be applied with mild soap and water. Uncircumcised males treating warts under their penis foreskin must pull their foreskin back and clean the area before treatment, and clean the area daily during treatment.

• Allow the area to dry for at least 10 minutes.

• Wash your hands.

• Open a new packet of Imiquimod Cream.

• Apply a thin layer of Imiquimod Cream only to the affected area. Do not use more Imiquimod Cream than is needed to cover the affected area.

• Rub the cream into your skin until you can not see the Imiquimod Cream. After applying Imiquimod Cream, wash your hands well.

• Leave the cream on the treated area for the amount of time your healthcare provider tells you. The length of time that Imiquimod Cream is left on the skin is different for each skin condition that Imiquimod Cream is used to treat. Do not take a bath or get the treated area wet during this time.

• After the right amount of time has passed, wash the treated area with mild soap and water.

• If you get Imiquimod Cream in your mouth or in your eyes, rinse well with water right away.

Side effects, and when to stop

Imiquimod Cream may cause serious side effects including:

Local skin reactions, including:

• skin drainage (weeping)

• ulcers

• severe swelling near the vagina. This may lead to pain or trouble passing urine or cause you not to be able to urinate. Female patients should take special care when applying Imiquimod Cream at the opening of the vagina.

Flu-like symptoms: tiredness, fever, nausea, muscle pain and chills.

Tell your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of Imiquimod Cream include:

• itching

• burning

• redness

• flaking and scaling

• dryness

• scabbing and crusting

• swelling

• skin that becomes hard or thickened

• sores, blisters, or ulcers

• changes in skin color that do not always go away

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of Imiquimod Cream. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What to say before you start

Before using Imiquimod Cream, tell your healthcare provider if you:

• have problems with your immune system.

• are being treated or have been treated for actinic keratosis with other medicines or surgery. You should not use Imiquimod Cream until you have healed from other treatments.

• have any other skin problems

• have any other medical conditions

• are pregnant or planning to become pregnant. It is not known if Imiquimod Cream can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if Imiquimod Cream passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use Imiquimod Cream.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you have had other treatments for genital warts or warts around your anus, or actinic keratosis, or superficial basal cell carcinoma. Imiquimod Cream should not be used until your skin has healed from other treatments. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What to avoid

• Do not cover the treated area with bandages or other closed dressings.

• Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Imiquimod Cream. Use sunscreen and wear protective clothing if you go outside during daylight.

• Do not have sexual contact including genital, anal, or oral sex when Imiquimod Cream is on your genitals or the skin around your anus. Imiquimod Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy.

Storing it

• Store Imiquimod Cream between 39ºF to 77°F (4ºC to 25ºC).

• Do not freeze.

• Safely throw away unused Imiquimod Cream or partially used Imiquimod Cream packets that you do not need.

Keep Imiquimod Cream and all medicines out of the reach of children.

General information about the safe and effective use of Imiquimod Cream

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not use Imiquimod Cream for a condition for which it was not prescribed. Do not give Imiquimod Cream to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Imiquimod Cream. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Imiquimod Cream that is written for the healthcare professionals.