Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you have had other treatments for genital warts or warts around your anus, or actinic keratosis, or superficial basal cell carcinoma. Aldara (imiquimod) cream should not be used until your skin has healed from other treatments.

The animal multiples of human exposure calculations were based on weekly dose comparisons for the carcinogenicity studies described in this label. The what is aldara cream used for multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this label. Systemic embryofetal development studies were conducted in rats and rabbits.

A combined fertility and periand postnatal development study was conducted in rats. Oral doses of 1, 1. This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod.

The clinical response of each subject was evaluated 8 weeks after the last scheduled application of study cream. Complete and partial clearance rates are shown in the table below. Target tumors were not to be located within 1.

The overall median peak serum drug concentrations at the end of week 4 was between 0. Children aged 25 years received doses of 12. Children aged 612 years received doses of 12.

These reactions can range from mild to severe in intensity and may extend beyond the application site onto the surrounding skin. Local skin reactions may be of such intensity that patients may require rest periods from treatment. Patients should contact their physician promptly if they experience any sign or symptom at the application site that restricts or prohibits their daily activity or makes continued application of the cream difficult.

If you would like more information, talk with your healthcare provider. See additional information.

There are no adequate and wellcontrolled studies in pregnant women. Safety and efficacy in patients with external genital/perianal warts below the age of 12 years have not been established. These studies failed to demonstrate efficacy.

Similar to the studies conducted in adults, the most frequently reported adverse reaction from 2 studies in children with molluscum contagiosum was application site reaction. Erythema was the most frequently reported local skin reaction. The investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subject's weight.

However it appears that systemic exposure may be more dependent on surface area of application than amount of applied dose. The apparent halflife was approximately 10 times greater with topical dosing than the 2 hour apparent halflife seen following subcutaneous dosing, suggesting prolonged retention of drug in the skin. Mean urinary recoveries of imiquimod and metabolites combined were 0.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Aldara (imiquimod) cream is used for different skin conditions.

In many cases genital warts do not cause any symptoms, but they are sometimes associated with itching, burning, or tenderness. Each gram contains 50 mg of imiquimod in an offwhite oilinwater vanishing cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash the area where the cream will be applied with mild soap and water. Uncircumcised males treating warts under their penis foreskin must pull their foreskin back and clean the area before treatment, and clean the area daily during treatment. Allow the area to dry for at least 10 minutes.

The treatment area is defined as one contiguous area of approximately 25 cm (e. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes). Contact with the eyes, lips and nostrils should be avoided.

After the right amount of time has passed, wash the treated area with mild soap and water. Do not cover the treated area with bandages or other closed dressings. Use sunscreen and wear protective clothing if you go outside during daylight.

Lesions that do not respond to treatment should be carefully reevaluated and management reconsidered. Patients should be prescribed no more than 36 packets for the 16week treatment period. Unused packets should be discarded.

This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. Aldara (imiquimod) cream is a prescription medicine for use on the skin only (topical) to treat: actinic keratosis on the face or scalp in adults with a normal immune system. Actinic keratosis is caused by too much sun exposure.

The 25 cm contiguous treatment area could be of any dimensions e. On a scheduled dosing day, the study cream was applied to the entire treatment area prior to normal sleeping hours and left on for approximately 8 hours. Twice weekly dosing was continued for a total of 16 weeks.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects. No other clinical experience has identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. The most clinically serious adverse event reported following multiple oral imiquimod doses of 200 mg (equivalent to imiquimod content of 16 packets) was hypotension, which resolved following oral or intravenous fluid administration.

If there is clinical evidence of persistent tumor at the posttreatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Patients should be prescribed no more than 36 packets for the 6week treatment period. The application site should not be occluded.

The incidence and severity of local skin reactions during controlled clinical trials are shown in the following table. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hepatic: abnormal liver function.

Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling.

A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions.

Female patients should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can result in pain or severe swelling, and may cause difficulty in passing urine or inability to urinate. Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily. Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water.

Therefore, patients should minimize or avoid natural or artificial sunlight exposure. The treatment area should not be bandaged or otherwise occluded. Potential local skin reactions include erythema, edema, vesicles, erosions/ulcerations, weeping/exudate, flaking/scaling/dryness, and scabbing/crusting.

Aldara (imiquimod) cream will not cure your genital or perianal warts. Children usually do not get actinic keratoses or basal cell carcinoma. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

The average number of doses not received per subject due to rest periods was 7 doses with a range of 2 to 22 doses; 79% of subjects (15/19) resumed therapy after a rest period. Overall, in the clinical studies, 2% (4/185) of subjects discontinued for local skin/application site reactions. Some subjects also reported systemic reactions.

Wash your hands. Leave the cream on the treated area for the amount of time your healthcare provider tells you. Do not take a bath or get the treated area wet during this time.

However, the clinical relevance of these findings is unknown. Mean peak serum drug concentrations at the end of week 16 were approximately 0. Dose proportionality was not observed.

Aldara (aldara ordering online) cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. This may lead to pain or trouble passing urine or cause you not to be able to urinate.

In a dermal mouse carcinogenicity study, imiquimod cream (up to 5 mg/kg/application imiquimod or 0. An increased number of skin papillomas was observed in vehicle cream control group animals at the treated site only. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, imiquimod, to the vehicle cream.

Patients should be warned to use protective clothing (e. Patients who may have considerable sun exposure, e. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms.

On a scheduled dosing day, study cream was applied to the target tumor and approximately 1 cm (about 1/3 inch) beyond the target tumor prior to normal sleeping hours, and 5 times per week dosing was continued for a total of 6 weeks. The target tumor area was clinically assessed 12 weeks after the last scheduled application of study cream. The entire target tumor was then excised and examined histologically for the presence of tumor.

Data on composite clearance (defined as both clinical and histological clearance) are shown in the table below. Target tumor inclusion criteria were the same as for the studies described above. The median baseline wart area was 69 mm (range 8 to 5525 mm).

Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. The incidence of adverse reactions reported by 1% of subjects during the studies is summarized below. The incidence of application site reactions reported by 1% of the subjects during the 6 week treatment period is summarized in the table below.

Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e. Local skin reactions or other findings (e.

Call your doctor for medical advice about side effects. Do not freeze. It may harm them.

Oral doses of 1, 5 and 20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6 15) to pregnant female rats. Intravenous doses of 0. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (1.

Following the treatment period the cream should be removed by washing the treated area with mild soap and water. Treatment may resume once the reaction subsides. Nonocclusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

Flulike symptoms: tiredness, fever, nausea, muscle pain and chills. Tell your healthcare provider right away if you have any of the symptoms listed above. For more information, ask your healthcare provider or pharmacist.

Partiallyused packets should be discarded and not reused. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly. The treatment area should include a 1 cm margin of skin around the tumor.

The clinical outcome of therapy can be determined after resolution of application site reactions and/or local skin reactions. It is common for patients to experience local skin reactions such as erythema, erosion, excoriation/flaking, and edema at the site of application or surrounding areas. Most skin reactions are mild to moderate.

Subject accountability is shown in the figure below. The median time to complete wart clearance was 10 weeks. There may be new information.

Keep out of reach of children. The most frequently reported local skin reactions were erythema, flaking/scaling/ dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Because of local skin reactions, during treatment and until healed, the treatment area is likely to appear noticeably different from normal skin. These skin color changes may be permanent in some patients. An interruption of dosing should be considered.

Systemic absorption of imiquimod was observed across the affected skin of 12 subjects with genital/perianal warts, with an average dose of 4. Mean peak drug concentration of approximately 0. Mean urinary recoveries of imiquimod and metabolites combined over the whole course of treatment, expressed as percent of the estimated applied dose, were 0.

Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied. Less serious side effects may include: mild skin irritation, dryness, flaking, scabbing, redness, or hardening of the skin where the medicine was applied;. Aldara (imiquimod) is not for oral, ophthalmic, or intravaginal use.