Imiquimod (Topical Route)

It is not used on warts inside the vagina, penis, or rectum . Imiquimod is also used 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 superficial basal cell carcinoma (sBCC).

It works by aiding the immune system to help protect the body from viruses that cause warts. The medicine does not fight the viruses that cause warts directly . It does help to relieve and control wart production. It is not known how imiquimod helps actinic keratoses or skin cancer.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Cream


• Kit

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of imiquimod in children up to 12 years of age with use in other age groups. Actinic keratosis and basal cell carcinoma usually do not occur in children.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of imiquimod in the elderly with use in other age groups. However, older adults may be more sensitive to the effects of imiquimod.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to imiquimod, parabens, or any ingredients in the producta€”This drug should not be used

• Autoimmune disordersa€”Tell your doctor if you have this condition; you and your doctor will decide if this medicine is right for you.

• Inflamed skina€”May make condition worse

• Lower immune response (your body is not able to fight infections as well)a€”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)a€”Imiquimod should not be used until the skin is completely healed from any previous treatments that you have had with medicine or surgery

• Sensitive to sunlighta€”Use caution as you may have a higher risk of getting a sunburn

• Sunburna€”Should not use until sunburn is gone

Proper Use

To apply the medicine:

• Wash your hands before and after using the medicine . Avoid getting the medicine into your eyes, lips, or nostrils or in vagina 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 it longer than directed .


• Allow medicine to stay on skin for 8 hours if you are using it for actinic 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 should retract the foreskin and clean the area daily .


• Throw out any unused cream from the single-dose packet.


• Do not apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over the medicine, unless told to do so by your doctor . To do so may cause irritation of the skin . Other materials that are not airtight, such as cotton gauze or cotton underclothes, may be used.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  
  
  
  • For skin condition on face and scalp called actinic keratoses:
    
    
    
    • Adultsa€”Apply a thin film to the treatment area two times a week 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 washing with mild soap and water . Continue treatment until skin condition is gone or for up to sixteen weeks.
    
    
    • Childrena€”Use and dose must be determined by doctor .
    
    
    
    
  
  
  
  
  
  
  • For skin cancer called basal cell carcinoma:
    
    
    
    • Adultsa€”Apply a thin film to the treatment area five times a week before normal sleeping hours Monday through Friday. Rub in well and leave on for about 8 hours. Remove medicine from skin by washing with mild soap and water . Continue treatment until skin condition is gone or for up to six weeks.
    
    
    • Childrena€”Use and dose must be determined by doctor .
    
    
    
    
  
  
  
  
  
  
  • For warts on the skin outside of the genital or rectal areas (condyloma acuminatum):
    
    
    
    • Adultsa€”Apply a thin film to wart once every other day (three times a week) before normal sleeping hours. Rub in well and leave on for six to 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.
    
    
    • Childrena€”Use and dose must be determined by doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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 times a week that you use the medicine or to stop using the medicine for a short time until your skin is less irritated or your flu-like symptoms disappear.

For treatment of warts on the skin outside of the genital or 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 during treatment with imiquimod.

Imiquimod will not keep your from spreading genital warts to other people .

Do not use any other skin product on the same skin area on which you use this medicine, unless directed otherwise by your doctor .

Do not share your medicine with others, even if you think that they have the same condition you have.

Side Effects

Along with its needed effects, a medicine may cause 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 possible if any of the following side effects occur:

More common

• Blisters on skin


• Body aches or pain


• Chills


• Cough


• Difficulty in breathing


• Ear congestion


• Itching in genital or other skin areas


• Loss of voice


• Nasal congestion


• Open sores or scabs on skin


• Pain or tenderness around eyes and cheekbones


• Redness of skin (severe)


• Scaling


• Shortness of breath or troubled breathing


• Skin rash


• Sneezing


• Sore throat


• Stuffy or runny nose


• Tightness of chest or wheezing


• Unusual tiredness or weakness

Less common

• Abdominal pain


• Ankle, knee, or great toe 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


• Slow or fast heartbeat


• Swollen, painful, or tender lymph glands in neck, armpit, or groin


• White, yellow or waxy scar-like area

Incidence unknown

• Blurred vision


• Blue lips and fingernails


• Convulsions


• Coughing that sometimes produces a pink frothy sputum


• Difficulty breathing


• Dilated neck veins


• Dizziness


• Extreme fatigue


• Faintness


• Fast, irregular or pounding heartbeat


• Headache


• Irregular breathing


• 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, or lower 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

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning or stinging of skin (mild)


• Flaking of skin


• Mild headache


• Pain, soreness, or tenderness of skin (mild)


• Rash


• Redness of skin (mild)


• Swelling at place of application

Less common

• Back pain


• Fever


• Lightening of the treated skin


• Nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.