Aldara

/ Megapharm

The application frequency for Aldara Cream is different for each indication.
Actinic Keratosis: Aldara Cream is to be applied 2 times per week for 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area should be one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm). Imiquimod cream should be applied to the entire treatment area (e.g., the forehead, scalp, or one cheek). Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 16 week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused. 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). The patient should apply no more than one packet of Aldara Cream to the contiguous treatment area at each application. Aldara Cream is applied prior to normal sleeping hours, and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The cream should be rubbed into the treatment area until the cream is no longer visible. Contact with the eyes, lips and nostrils should be avoided. Examples of two times per week application schedules are Monday and Thursday, or Tuesday and Friday prior to sleeping hours. Aldara Cream treatment should continue for the full 16 weeks. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Local skin reactions in the treatment area are common. Patients should contact their physician if they experience any sign or symptom in the treatment area that restricts or prohibits their daily activity or makes continued application of the cream difficult. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. The technique for proper dose administration should be demonstrated by the prescriber to maximize the benefit of Aldara Cream therapy. Handwashing before and after cream application is recommended. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.
Superficial Basal Cell Carcinoma: Aldara Cream is to be applied 5 times per week for 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. The target tumor should have a maximum diameter of no more than 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 6 week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused. Aldara Cream is to be applied 5 times per week, prior to normal sleeping hours, and left on the skin for approximately 8 hours. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one centimeter of skin surrounding the tumor. The cream should be rubbed into the treatment area until the cream is no longer visible. Eye contact should be avoided. Following the treatment period, cream should be removed by washing the area with mild soap and water. An example of a 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday, prior to sleeping hours. Aldara Cream treatment should continue for 6 weeks. Local skin reactions in the treatment area are common. Patients should contact their physician if they experience any sign or symptom in the treatment area that restricts or prohibits their daily activity or makes continued application of the cream difficult. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. The technique for proper dose administration should be demonstrated by the prescriber to maximize the benefit of Aldara Cream therapy. Handwashing before and after cream application is recommended. Early clinical clearance cannot be adequately assessed until resolution of local skin reactions. It is appropriate to have the first follow-up visit at approximately 12 weeks post-treatment to assess the treatment site for clinical clearance. Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the 12 week post-treatment visit. If there is clinical evidence of persistent tumor at the 12 week post-treatment assessment, a biopsy or other alternative intervention should be considered; the safety and efficacy of a repeat course of Aldara Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after 12 weeks, the patient should seek a medical evaluation.
For full details see prescribing information.

Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acumunata in adult patients. For the treatment of actinic keratoses in adults with normal immune systems. Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment , since safety and effectiveness of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types.

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. Warnings The diagnosis of sBCC should be confirmed prior to treatment, since safety and effectiveness of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types and is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Aldara Cream are recommended to have regular follow-up of the treatment site. Aldara Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intraanal human papilloma viral disease and is not recommended for these conditions.

General: The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established. 7 Aldara Cream administration is not recommended until the skin is completely healed from any previous drug or surgical treatment. Aldara Cream has the potential to exacerbate inflammatory conditions of the skin. 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 (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. Phototoxicity has not been adequately assessed for Aldara Cream. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the absence of observed phototoxicity in humans, Aldara Cream shortened the time to skin tumor formation in an animal photoco-carcinogenicity study. Therefore, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure.
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 25 cm2 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.
Superficial Basal Cell Carcinoma: The safety and efficacy of treating superficial basal cell carcinoma (sBCC) lesions on the face, head and anogenital area have not been established. The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
For full details see prescribing information.

Dermal safety studies involving induction and challenge phases produced no evidence that Aldara Cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Aldara Cream to cause irritation, and in the clinical studies application site reactions were reported in a significant percentage of study patients. Phototoxicity testing was incomplete as wavelengths in the UVB range were not included and Aldara Cream has peak absorption in the UVB range (320 nm) of the light spectrum.
For full details see prescribing information.

none known.

Pregnancy: For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see 5.3). Caution should be exercised when prescribing to pregnant women.
Lactation: As no quantifiable levels (>5 ng/ml) of imiquimod are detected in the serum after single and multiple topical doses, no specific advice can be given on whether to use or not in lactating mothers.

Persistent topical overdosing of Aldara Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. 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.