Aldara - General Information:

Aldara is an immune response modifier that acts as a toll-like receptor 7 agonist. Aldara is commonly used topically to treat warts on the skin of the genital and anal areas. Aldara does not cure warts, and new warts may appear during treatment. Aldara does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production. miquimod is also used to treat a skin condition of the face and scalp called actinic keratoses and certain types of skin cancer called superficial basal cell carcinoma.

Pharmacology:

Aldara is an immune response modifier that acts as a toll-like receptor 7 agonist. Aldara is commonly used topically to treat warts on the skin of the genital and anal areas. Aldara does not cure warts, and new warts may appear during treatment. Aldara does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production. It is not used on warts inside the vagina, penis, or rectum. Aldara is also used to treat a skin condition of the face and scalp called actinic keratoses. Aldara can also be used to treat certain types of skin cancer called superficial basal cell carcinoma. Aldara is particularly useful on areas where surgery or other treatments may be difficult, complicated or otherwise undesirable, especially the face and lower legs.

Aldara for patients

GENERAL INFORMATION

Patients using Aldara Cream should receive the following information and instructions:

1. This medication is to be used as directed by a physician. It is for external use only. Eye contact should be avoided.

2. The treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.

3. Some reports have been received of localized hypopigmentation and hyperpigmentation following Aldara Cream use. Follow-up information suggests that these skin color changes may be permanent in some patients.

Patients Being Treated for Actinic Keratosis (AK)

1. It is recommended that the treatment area be washed with mild soap and water 8 hours following Aldara Cream application.

2. It is common for patients to experience local skin reactions (can range from mild to severe in intensity) during treatment with Aldara Cream, and these reactions may extend beyond the application site onto the surrounding skin. Skin reactions generally decrease in intensity or resolve after cessation of Aldara Cream therapy. Potential local skin reactions include erythema, edema, vesicles, erosion/ulceration, weeping/exudate, flaking/scaling/dryness, and scabbing/crusting. Most patients using Aldara Cream for the treatment of AK experience erythema, flaking/scaling/dryness and scabbing/crusting at the application site with normal dosing. Patients may also experience application site reactions such as itching and/or burning. Local skin reactions may be of such an intensity that patients may require rest periods from treatment. Treatment with Aldara Cream can be resumed after the skin reaction has subsided, as determined by the physician. 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.

3. Because of local skin reactions, during treatment and until healed, the treatment area is likely to appear noticeably different from normal skin. The skin surrounding the treatment area may also be affected, but less intensely so.

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

5. Use of sunscreen is encouraged, and patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Aldara Cream.

6. During treatment, sub-clinical AK lesions may become apparent in the treatment area and may subsequently resolve.

7. Partially-used packets should be discarded and not reused.

8. Dosing is twice weekly for the full 16 weeks, unless otherwise directed by the physician. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods.

Patients Being Treated for Superficial Basal Cell Carcinoma (sBCC)

1. It is recommended that the treatment area be washed with mild soap and water 8 hours following Aldara Cream application.

2. Most patients using Aldara Cream for the treatment of sBCC experience erythema, edema, induration, erosion, scabbing/crusting and flaking/scaling at the application site with normal dosing. These local skin reactions generally decrease in intensity or resolve after cessation of Aldara Cream therapy. Patients may also experience application site reactions such as itching and/or burning. Local skin reactions may be of such an intensity that patients may require rest periods from treatment. Treatment with Aldara Cream can be resumed after the skin reaction has subsided, as determined by the physician.

3. During treatment and until healed, affected skin is likely to appear noticeably different from normal skin.

4. It is prudent for patients to minimize or avoid exposure to natural or artificial sunlight.

5. The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.

6. Patients should contact their physician 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.

7. Patients with sBCC treated with Aldara Cream are recommended to have regular follow-up to re-evaluate the treatment site.

Patients Being Treated for External Genital Warts

1. It is recommended that the treatment area be washed with mild soap and water 6-10 hours following Aldara Cream application.

2. 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. Severe skin reactions can occur and should be promptly reported to the prescribing physician. Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water. Treatment with Aldara Cream can be resumed after the skin reaction has subsided.

3. Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin.

4. Application of Aldara Cream in the vagina is considered internal and should be avoided. 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 swelling, and may cause difficulty in passing urine.

5. Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.

6. Patients should be aware that new warts may develop during therapy, as Aldara Cream is not a cure.

7. The effect of Aldara Cream on the transmission of genital/perianal warts is unknown.

8. Aldara Cream may weaken condoms and vaginal diaphragms, therefore concurrent use is not recommended.

 

Aldara Interactions

No information available.

 

Aldara Contraindications

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.

Additional information about Aldara

Aldara Indication: For the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Also indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.
Mechanism Of Action: Aldara's mechanism of action is via stimulation of innate and acquired immune responses, which ultimately leads to inflammatory cell infiltration within the field of drug application followed by apoptosis of diseased tissue. Aldara does not have direct antiviral activity. Studies of mice show that imiquimod may induce cytokines, including interferon-alpha (IFNA) as well as several IFNA genes (IFNA1, IFNA2, IFNA5, IFNA6, and IFNA8) as well as the IFNB gene. Aldara also induced the expression of interleukin (IL)-6, IL-8, and tumor necrosis factor alpha genes. In the treatment of basal cell carcinoma, Aldara appears to act as a toll-like receptor-7 agonist, and is thought to exert its anti-tumor effect via modification of the immune response and stimulation of apoptosis in BCC cells. In treating basal cell carcinoma it may increase the infiltration of lymphocytes, dendritic cells, and macrophages into the tumor lesion.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Imiquimod
Synonyms: Imiquimod acetate
Drug Category: Adjuvants, Immunologic; Antineoplastic Agents; Interferon Inducers; Antiviral Agents
Drug Type: Small Molecule; Approved; Investigational
Other Brand Names containing Imiquimod: Aldara;
Absorption: Well absorbed through skin (as a cream)
Toxicity (Overdose): Symptoms of overdose include flu-like symptoms, such as fever, fatigue, headache, nausea, diarrhoea and muscle pain.
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: 20 hours (topical dose), 2 hours (subcutaneous dose)
Dosage Forms of Aldara: Cream Topical
Chemical IUPAC Name: 1-(2-methylpropyl)imidazo[4,5-c]quinolin-4-amine
Chemical Formula: C14H16N4
Imiquimod on Wikipedia: http://en.wikipedia.org/wiki/Imiquimod
Organisms Affected: Humans and other mammals

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