This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths.
This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.
Read the Patient Information Leaflet provided by your pharmacist before you start using imiquimod and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Use this medication on the skin only. Apply this medication to the affected area once a day as directed by your doctor. The number of times and the length of time you apply this medication depend on the specific skin problem that is being treated. When treating actinic keratoses, apply twice a week for a full 16 weeks. When treating superficial basal cell carcinoma, apply 5 times a week for a full 6 weeks. When treating warts, apply 3 times a week for up to 16 weeks. If you have any questions about which days to apply this medication or how often or how long to use this medication, talk to your doctor or pharmacist.
Do not apply this medication into the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor immediately.
Use this medication regularly in order to get the most benefit from it. To help you remember, use a calendar to mark the days you will be applying the medication each week. Before applying the medication, wash the area to be treated with soap and water, and dry thoroughly. Use a new packet of cream for each use. Apply as directed by your doctor just before going to bed. Wash your hands with soap and water after each application. Do not cover the treated area with bandages or other waterproof coverings. Covering the area with cotton gauze, or cotton underwear if treating the genital area, is permitted. Leave the cream on overnight, usually for about 8 hours if treating actinic keratoses or basal cell carcinoma, or 6-10 hours for warts or as directed. In the morning, wash the treated area with soap and water to remove the cream. Do not bathe or wet the treated area before the prescribed application time has passed. Do not leave imiquimod cream on longer than prescribed by your doctor. Throw away any partly used packets of medication.
Tell your doctor if your condition persists or worsens or if new growths appear during treatment.
Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal. Follow your doctor's directions.
Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using imiquimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/unhealed surgery on the skin area to be treated, immune system problems (including HIV infection), a certain complication of bone marrow or some organ transplants (chronic graft-versus-host disease), autoimmune diseases (such as rheumatoid arthritis, scleroderma, lupus).
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.
To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.
During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, and therefore they may not work as well to prevent pregnancy or spreading of HPV or HIV.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.
This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Keep all medical appointments.
If you miss a dose, use it as soon as you remember. If you do not remember until the next day, skip the missed dose and resume your usual dosing schedule in the evening. Do not double the dose to catch up.
Refrigerate or store the US product at room temperature between 39-77 degrees F (4-25 degrees C). Store the Canadian product at room temperature between 59-77 degrees F (15-25 degrees C). Avoid freezing. Discard any medication that has been frozen. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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