IMIQUIMOD (Topical)
Some commonly used brand names are:
In the U.S.?
In Canada?
Category
- Biological response modifier
Description
Imiquimod (i-MI-kwi-mod) is used to treat externalwarts around the genital and rectal areas called condyloma acuminatum. Itis not used on warts inside the vagina, penis, or rectum. Imiquimod is alsoused to treat a skin condition of the face and scalp called actinic keratoses.Imiquimod can also be used to treat certain types of skin cancer called superficialbasal cell carcinoma (sBCC).
It works by aiding the immune system to help protect the body from virusesthat cause warts. The medicine does not fight the viruses that cause wartsdirectly. It does help to relieve and control wart production. It is not knownhow imiquimod helps actinic keratoses or skin cancer.
This medicine is available only with your doctor's prescription, in thefollowing dosage form:
Topical- Cream (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For imiquimod, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to imiquimod or parabens. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Imiquimod has not been shown to cause birth defectsor other problems in humans. However, studies in animals using doses higherthan recommended for humans have shown that imiquimod causes bone problems,brain problems, or low birth weight in pregnancies. Before taking this medicine,make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether imiquimod passes into breastmilk. However, this medicine has not been reported to cause problems in nursingbabies.
Children?Studies of this medicine have been done only in adultpatients, and there is no specific information comparing use of imiquimodin children up to 12 years of age with use in other age groups. Actinic keratosisand basal cell carcinoma usually do not occur in children.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof imiquimod in the elderly with use in other age groups. However, older adultsmay be more sensitive to the effects of imiquimod.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your doctor andpharmacist if you are using any other topical prescription or nonprescription(over-the counter [OTC]) medicine that is to be applied to the same area ofthe skin.
Other medical problems?The presence of other medicalproblems may affect the use of imiquimod. Make sure you tell your doctor ifyou have any other medical problems, especially:
- Allergy to imiquimod, parabens, or any ingredients in the product?Thisdrug should not be used
- Auroimmune disorders?Tell your doctor if you have this condition;you and your doctor will decide if this medicine is righr for you.
- Inflamed skin?May make condition worse
- Lower immune response (your body is not able to fight infectionsas well)?It is not known if imiquimod is safe to use with this condition
- Medicine that you have taken recently for the same skin problem or
- Surgery (recent)?Imiquimod should not be used until the skinis completely healed from any previous treatments that you have had with medicineor surgery
- Sensitive to sunlight?Use caution as you may have a higherrisk of getting a sunburn
- Sunburn?Should not use until sunburn is gone
Proper Use of This Medicine
To applythe medicine:
- Wash your hands before and after using the medicine. Avoid getting the medicine into your eyes, lips, or nostrils or invagina or anus.
- Use the medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use itlonger than directed.
- Allow medicine to stay on skin for 8 hours if you are using it foractinic keratoses or basal cell carcinoma, and 6 to 10 hours for genital warts,then wash area thoroughly with soap and water.
- Men not circumcised treating genital warts under the foreskin shouldretract the foreskin and clean the area daily.
- Throw out any unused cream from the single-dose packet.
- Do not apply an occlusive dressing (airtightcovering, such as kitchen plastic wrap) over the medicine, unless told todo so by your doctor. To do so may cause irritation of the skin. Other materialsthat are not airtight, such as cotton gauze or cotton underclothes, may beused.
Dosing?The dose of imiquimod will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of imiquimod. If your dose is different,do not change it unless your doctor tells you to do so.
- For topical dosage form (cream):
- For skin condition on face and scalp called actinic keratoses:
- Adults?Apply a thin film to the treatment area two times aweek before normal sleeping hours Monday and Thursday or Tuesday and Friday.Rub in well and leave on for about 8 hours. Remove medicine from skin by washingwith mild soap and water. Continue treatment until skin condition is goneor for up to sixteen weeks.
- Children?Use and dose must be determined by doctor.
- For skin cancer called basal cell carcinoma:
- Adults?Apply a thin film to the treatment area five times aweek before normal sleeping hours Monday through Friday. Rub in well and leaveon for about 8 hours. Remove medicine from skin by washing with mild soapand water. Continue treatment until skin condition is gone or for up to sixweeks.
- Children?Use and dose must be determined by doctor.
- For warts on the skin outside of the genital or rectal areas (condylomaacuminatum):
- Adults?Apply a thin film to wart once every other day (threetimes a week) before normal sleeping hours. Rub in well and leave on for sixto ten hours. Remove medicine from wart by washing with mild soap and water.Continue treatment until wart is gone or for up to sixteen weeks.
- Children?Use and dose must be determined by doctor.
Missed dose?If you miss a dose of this medicine, wait untilthe next evening to apply it. Then go back to your regular dosing schedule.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Keep the medicine from freezing. Do not refrigerate.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
If you notice severe skin irritation or flu-like symptoms (diarrhea,fatigue, fever, headache, or muscle pain), check with your doctor.It may be necessary for you to reduce the number of timesa week that you use the medicine or to stop using the medicine fora short time until your skin is less irritated or your flu-like symptoms disappear.
For treatment of warts on the skin outside of the genitalor rectal areas (condyloma acuminatum), avoid having genital, oral,or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity.Also, the medicine contains oils that can weaken latex (rubber) condoms, diaphragms,or cervical caps causing them not to work properly to prevent pregnancy.
Imiquimod is not a cure for genital warts. New warts may develop duringtreatment with imiquimod
Imiquimod will not keep you from spreading genital warts to other people.
Do not use any other skin product on the same skinarea on which you use this medicine, unless directed otherwise by yourdoctor.
Do not share your medicine with others, evenif you think that they have the same condition you have.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
Check with your doctor as soon as possibleif any of the following side effects occur:
Less common
Abdominal pain; ankle, knee, or greattoe joint pain; blurred vision; chest pain; dizziness; bladder pain; bloody or cloudy urine; cold flu-like symptoms; difficult, burning,or painful urination; fainting; fast or irregular heartbeat; frequent urge to urinate; joint stiffness or swelling; high amount of cholesterol in the blood; hoarseness; lower back or side pain; lump in abdomen; nervousness; persistent non-healing sore; pink growth on skin; pounding in the ears; reddish patch or irritated area; severe headache; shiny bump on skin; slowor fast heartbeat; swollen, painful, or tender lymphglands in neck, armpit, or groin; white, yellow orwaxy scar-like area
Incidence unknown?Observed during clinical practice, estimates of frequencycan not be determined
Blurred vision; blue lips and fingernails; convulsions; coughing that sometimes produces apink frothy sputum; difficulty breathing; dilated neck veins; dizziness; extreme fatigue; faintness; fast, irregular or pounding heartbeat; irregular breathing; headache; irregular heartbeat; nausea or vomiting ; pain in the shoulders, arms, jaw or neck; seizures; shortness of breath; slurred speech; sudden and severe inability to speak; suicide; sweating; swelling of face, fingers, feet, orlower legs; temporary blindness; weakness in arm and/or leg on one side of the body; weight gain; wheezing
Symptoms of overdose
Flu-like symptoms, including diarrhea, fatigue, fever, headache,or muscle pain
Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:
Incidence unknown?Observed during clinical practice, estimates of frequencycan not be determined
Agitation; cloudy urine; cracks in the skin ; decrease or increase in amount of urine; depression; lab results that show problems with liver; large, hive-like swelling on face, eyelids, lips,tongue, throat, hands, legs, feet, sex organs; lossof heat from the body ; multiple sclerosis aggravation; pale skin; red, swollenskin; scaly skin; sleeplessness ; swelling of neck; trouble sleeping; unable to sleep
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Developed: 06/30/1998
Revised: 10/19/2005
