Aldara warnings and precautions
Local Inflammatory Reactions
Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Aldara Cream and may require an interruption of dosing. Aldara Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Administration of 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 Aldara Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Aldara Cream. Patients with sunburn should be advised not to use Aldara Cream 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 Cream.
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 Cream in the treatment of actinic keratosis with repeated use, i.e. more than one treatment course, in the same area.
The safety of Aldara Cream applied to areas of skin greater than 25 cm2 (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 Cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types. Aldara Cream is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Aldara Cream 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
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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