Zyclara (Imiquimod)

(i mi kwi' mod)

Imiquimod cream is used to treat certain types of actinic keratoses (flat, scaly growths on the skin caused by too much sun exposure) on the face or scalp. Imiquimod cream is also used to treat superficial basal cell carcinoma (a type of skin cancer) on the trunk, neck, arms, hands, legs, or feet and warts on the skin of the genital and anal areas. Imiquimod is in a class of medications called immune response modifiers. It treats genital and anal warts by increasing the activity of the body's immune system. It is not known exactly how imiquimod cream works to treat actinic keratoses or superficial basal cell carcinoma. Imiquimod cream does not cure warts, and new warts may appear during treatment. It is not known whether imiquimod cream prevents the spread of warts to other people.

Imiquimod comes as a cream to apply to the skin. If you are using imiquimod cream to treat actinic keratoses, you will probably apply it once a day for 2 days a week, 3 to 4 days apart (e.g., Monday and Thursday or Tuesday and Friday). Do not apply the cream to an area larger than your forehead or cheek (about 2 inches by 2 inches). Imiquimod cream should be left on the skin for approximately 8 hours. Continue using imiquimod cream for a full 16 weeks, even if all the actinic keratoses are gone, unless you are told otherwise by your doctor. If you are using imiquimod cream to treat superficial basal cell carcinoma, you will probably apply it once a day for 5 days a week (e.g., Monday through Friday). Apply the cream to the basal cell carcinoma and the immediate surrounding area. Imiquimod cream should be left on the skin for approximately 8 hours. Continue using imiquimod for a full 6 weeks, even if the superficial basal cell carcinoma appears to be gone, unless you are told otherwise by your doctor. If you are using imiquimod cream to treat genital and anal warts, you will probably apply it once a day for 3 days a week (e.g., Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). Imiquimod cream should be left on the skin for 6 to 10 hours. Continue using imiquimod until all of the warts are healed, up to a maximum of 16 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use imiquimod exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Do not cover the treated area with a tight bandage or dressing unless told to do so by your doctor. Cotton gauze dressings may be used if needed. Cotton underwear may be worn after treating the genital or anal areas. If you are using imiquimod cream to treat genital or anal warts, you should avoid sexual (oral, anal, genital) contact while the cream is on your skin. Imiquimod cream may weaken condoms and vaginal diaphragms. Uncircumcised men who are treating warts under the penis foreskin should pull the foreskin back and clean daily and before each treatment. Imiquimod cream is only for use on the skin. Do not apply imiquimod cream in or near your eyes, lips, nostrils, vagina, or anus. If you get imiquimod cream in your mouth or eyes, rinse well with water right away. Imiquimod cream comes in single-use packets. Dispose of any open packets if you do not use all of the cream. To use the cream, follow these steps:

• Wash your hands.
• Wash the area to be treated with mild soap and water and allow it to dry.
• Apply a thin layer of cream to the area to be treated, just before going to sleep.
• Rub the cream into the skin until it disappears.
• Wash your hands.
• Leave the cream on the area for the amount of time your doctor has told you to do so. Do not bathe, shower, or swim during this time.
• After the treatment time is over, wash the area with mild soap and water to remove any cream.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using imiquimod,
• tell your doctor and pharmacist if you are allergic to imiquimod, any of the ingredients in imiquimod cream, or any other medications. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any other treatments for genital or anal warts, actinic keratoses, or superficial basal cell carcinoma.
• tell your doctor if you have a sunburn or if you have or have ever had unusual sensitivity to sunlight, any skin disease such as psoriasis, graft vs. host disease, recent surgery to the affected area or any condition that affects the immune system (such as human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using imiquimod, call your doctor.
• plan to avoid exposure to sunlight as much as possible and to wear protective clothing (such as a hat), sunglasses, and sunscreen if you go outside during daylight hours. Do not use tanning beds or sunlamps. Imiquimod cream may make your skin sensitive to sunlight.
• you should know that imiquimod cream may cause changes in your skin color. These changes may not go away after you finish treatment with imiquimod cream. Tell your doctor if you notice any changes in your skin color.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra cream to make up for a missed dose.

Imiquimod cream may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, burning, or bleeding of the treated area
• flaking, scaling, dryness, or thickening of the skin
• swelling, stinging, or pain in the treated area
• blisters, scabs, or bumps on the skin
• headache
• diarrhea
• back pain
• tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• skin breakdown or sores that may have drainage, especially during the first week of treatment
• flu-like symptoms such as nausea, fever, chills, tiredness, and muscle weakness or pain

Imiquimod may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

If someone swallows imiquimod cream, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor. If you are using imiquimod cream to treat superficial basal cell carcinoma, it is important to have regular follow-up visits with your doctor. Ask your doctor how often you should have your skin checked. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.