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ALDARA CREAM (IMIQUIMOD): WARNINGS AND PRECAUTIONS

Local Inflammatory Reactions

Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Aldara (Imiquimod) topical cream and may require an interruption of dosing. Aldara (Imiquimod) cream 5% has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.

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.

Administration of Imiquimod (Aldara) cream is not recommended until the skin is completely healed from any previous drug or surgical treatment.

Systemic Reactions

Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered.

Ultraviolet Light Exposure

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Imiquimod (Aldara) topical cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Imiquimod (Aldara) cream 5%. Patients with sunburn should be advised not to use this medication until fully recovered. Patients who may have considerable sun exposure, e.g. due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using Aldara.

Aldara cream shortened the time to skin tumor formation in an animal photoco-carcinogenicity study. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure.

Unevaluated Uses: Actinic Keratosis

Safety and efficacy have not been established for Aldara (Imiquimod) in the treatment of actinic keratosis with repeated use, i.e. more than one treatment course, in the same area. The safety of Imiquimod (Aldara) applied to areas of skin greater than 252 cm (e.g. 5 cm x 5 cm) for the treatment of actinic keratosis has not been established.

Unevaluated Uses: Superficial Basal Cell Carcinoma

The safety and efficacy of Aldara (Imiquimod) cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types. Aldara (Imiquimod) topical cream is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Aldara (Imiquimod) cream 5% should have regular follow-up of the treatment site.

The safety and efficacy of treating sBCC lesions on the face, head and anogenital area have not been established.

Unevaluated Uses: External Genital Warts

Imiquimod (Aldara) cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.



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