Aldara Cream

The active ingredient in Aldara is imiquimod, an immune response modifier. This medication stimulates your body’s own immune response. This helps your body fight against abnormal skin cells, cancer cells, and viruses to resolve superficial basal cell carcinoma, actinic keratosis, and warts caused by HPV.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Aldara. However, the following is a synopsis of the general guidelines for the use of Aldara:

-Cleanse the skin with a mild soap and let it dry fully.

-Apply a thin layer of cream to the affected area.

-Rub in the cream until it is no longer visible. Wash your hands after each application.

-Leave the cream on for 8 hours overnight. Do not cover the treated areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area.

-Wash off the cream with soap and water in the morning.

For the treatment of superficial basal cell carcinoma (SBCC), the cream should be applied five nights per week for 6 weeks. It should be applied to the lesion and to a 1cm margin of healthy skin around the lesion. You should be reassessed by your doctor after 12 weeks.

For the treatment of actinic keratosis, the cream should be applied to an area no more than 25cm2 twice per week for 16 weeks.

For the treatment of genital warts, Aldara cream should be applied to an area no more than 20cm2 three times per week until resolution of the warts, for up to 16 weeks. If you are using the cream to treat an area under the penis foreskin, you should pull back the foreskin to clean the area every morning.

If you miss a dose of Aldara, do not apply a larger quantity. Skip the missed dose and apply a thin layer of cream as per your dosing schedule.

Some mild or common side effects of Aldara include:

-Skin reactions like redness, dryness, burning, tingling, scabbing, crusting, or flaking of the skin at the application site.

-Fatigue.

-Fever.

-Headache.

Some individuals may experience serious side effects while using Aldara. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Systemic side effects like fever, nausea, flu-like symptoms, muscle pain, back pain, joint pain, or stiffness.

-Serious allergic reactions with symptoms such as hives, swelling of the face, tongue, or throat, and trouble breathing.

These are not all of the possible side effects of Aldara. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read the patient information leaflet, medication guide, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

The efficacy of Aldara in the treatment of superficial basal cell carcinoma is lower than that of surgery. The lesions should be monitored regularly to determine if alternative treatment methods are required.

Avoid sun exposure (outside, in tanning beds, or through sunlamps). The treated area may be more susceptible to sunburns. Wear sunscreen and protective clothing covering the treatment area to avoid sunburns.

Aldara was not studied in the treatment of superficial basal cell carcinoma on the face, head, hands, feet, or genital area.

Aldara cream can weaken condoms and diaphragms. Use an additional method of contraception while using Aldara.

Before starting Aldara cream, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

-Other skin conditions, a weakened immune system, an autoimmune disorder, or graft-versus-host disease.

-Had a recent surgical treatment to the area to which Aldara is to be applied.

-Used any other medications on the affected skin areas.

Aldara should not be used in people who are allergic to imiquimod or other inactive ingredients of the formulation.

Aldara is not intended for intra-anal or intra-vaginal use.

Aldara has not been studied in the treatment of superficial basal cell carcinoma lesions larger than 2 cm or for the treatment of actinic keratosis lesions larger than 25cm.

Aldara should not be used if you have a compromised immune system.

The safety of Aldara in people less than 18 years old has not been established.

It may take weeks for the treated skin lesions to resolve. Apply Aldara for as long as your doctor directs you to.

Drug interactions with Aldara cream are not well established. However, when Aldara is used with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Other topical medications, including topical steroid creams.

-Medications that suppress your immune system, like tacrolimus, pimecrolimus, mycophenolate mofetil, cyclosporine, or methotrexate.

Aldara is available in a cream dosage form containing 5% imiquimod. Other brand names of imiquimod topical include Zyclara.

Store Aldara cream at room temperature, out of the reach of children.

Aldara is manufactured by Bausch Health, Canada Inc.

Yes, a generic version of Aldara cream is available.

Do not use Aldara for longer than directed by your doctor.

Aldara has not been well studied in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Aldara is absorbed topically and secreted into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.