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Aldara

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Aldara

Indications
Dosage
How Supplied

INDICATIONS

Actinic Keratosis

Aldara (imiquimod) Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Superficial Basal Cell Carcinoma

Aldara (imiquimod) 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 efficacy of Aldara (imiquimod) Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.

External Genital Warts

Aldara (imiquimod) Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older.

Limitations of Use

Aldara (imiquimod) Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations].

Unevaluated Populations

The safety and efficacy of Aldara (imiquimod) Cream in immunosuppressed patients have not been established.

Aldara (imiquimod) Cream should be used with caution in patients with pre-existing autoimmune conditions.

The efficacy and safety of Aldara (imiquimod) Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

DOSAGE AND ADMINISTRATION

The application frequency for Aldara (imiquimod) Cream is different for each indication.

Aldara (imiquimod) is not for oral, ophthalmic, or intravaginal use.

Actinic Keratosis

Aldara (imiquimod) Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm² (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara (imiquimod) Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara (imiquimod) Cream should be applied to the contiguous treatment area at each application. Aldara (imiquimod) Cream should be 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 prescriber should demonstrate the proper application technique to maximize the benefit of Aldara (imiquimod) Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara (imiquimod) Cream. 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.

Local skin reactions in the treatment area are common [see ADVERSE REACTIONS]. 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. Lesions that do not respond to treatment should be carefully reevaluated and management reconsidered.

Aldara (imiquimod) Cream is packaged in single-use packets, with 24 packets supplied per box. Patients should be prescribed no more than 36 packets for the 16-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

Superficial Basal Cell Carcinoma

Aldara (imiquimod) Cream should be applied 5 times per week for a full 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. An example of a 5 times per week application schedule is to apply Aldara (imiquimod) Cream, once per day, Monday through Friday. Aldara (imiquimod) Cream should be 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 prescriber should demonstrate the proper application technique to maximize the benefit of Aldara (imiquimod) Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara (imiquimod) Cream. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly.

The target tumor should have a maximum diameter of 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. Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Aldara (imiquimod) Cream should be rubbed into the treatment area until the cream is no longer visible.

Table 1. Amount of Aldara (imiquimod) Cream to Use for sBCC

Target Tumor Diameter Size of Cream Droplet to be Used (diameter) Approximate Amount of Aldara to be Used
0.5 to < 1.0 cm 4 mm 10 mg
≥ 1.0 to < 1.5 cm 5 mm 25 mg
≥ 1.5 to 2.0 cm 7 mm 40 mg

Contact with the eyes, lips and nostrils should be avoided.

Local skin reactions in the treatment area are common [see ADVERSE REACTIONS]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.

Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e.g. 12 weeks post-treatment). Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the post-treatment assessment for clinical clearance. If there is clinical evidence of persistent tumor at the post-treatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered; the safety and efficacy of a repeat course of Aldara (imiquimod) Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after a determination of clinical clearance, the patient should seek a medical evaluation [see Clinical Studies.

Aldara (imiquimod) Cream is packaged in single-use packets, with 24 packets supplied per box. Patients should be prescribed no more than 36 packets for the 6-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

External Genital Warts

Aldara (imiquimod) Cream should be applied 3 times per week to external genital/perianal warts. Aldara (imiquimod) Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Aldara (imiquimod) Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara (imiquimod) Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara (imiquimod) Cream.

A thin layer of Aldara (imiquimod) Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.

Local skin reactions at the treatment site are common [see ADVERSE REACTIONS]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

Aldara (imiquimod) Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm²; use of excessive amounts of cream should be avoided.

HOW SUPPLIED

Dosage Forms And Strengths

Aldara (imiquimod) Cream, 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Aldara (imiquimod) Cream is supplied in a box of 24 packets each.

Storage And Handling

Aldara (imiquimod) Cream, 5%, is supplied in single-use packets which contain 250 mg of the cream. Available as: box of 24 packets NDC 29336-610-24. Store at 4 - 25°C (39 - 77°F).

Avoid freezing.

Keep out of reach of children.

Manufactured by : 3M Health Care Limited, Loughborough LE11 1EP England. Distributed by Graceway Pharmaceuticals, LLC, Bristol, TN 37620. Revised: October 2010

Last reviewed on RxList: 11/12/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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