Imiquimod

What is Imiquimod?

• Imiquimod (Aldara) is an immune response modifier for topical administration used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis.

Imiquimod

Imiquimod-3D

What are the uses of this medicine?

Imiquimod (Aldara) Cream is a skin use only (topical) medicine used to treat:

• external genital and perianal warts in people 12 years and older.
• actinic keratosis in adults with normal immune systems. Actinic keratosis is caused by too much sun exposure.
• superficial basal cell carcinoma in adults with normal immune systems when surgical methods are less appropriate.

Limitations of Use:

• Aldara Cream will not cure your genital or perianal warts. New warts may develop during treatment with Aldara Cream.
• It is not known if Aldara Cream can stop you from spreading genital or perianal warts to other people.
• Efficacy was not demonstrated for molluscum contagiosum in children aged 2–12.

How does this medicine work?

• A synthetic agent with immune response modifying activity.
• As an immune response modifier (IRM), imiquimod stimulates cytokine production, especially interferon production, and exhibits antitumor activity, particularly against cutaneous cancers.
• Imiquimod's proapoptotic activity appears to be related to Bcl-2 overexpression in susceptible tumor cells.

Who Should Not Use this medicine ?

Limitations of Use:

• Aldara Cream will not cure your genital or perianal warts. New warts may develop during treatment with Aldara Cream.
• It is not known if Aldara Cream can stop you from spreading genital or perianal warts to other people.
• Efficacy was not demonstrated for molluscum contagiosum in children aged 2–12.

What drug interactions can this medicine cause?

• Tell your healthcare provider if you have had other treatments for genital or perianal warts, or actinic keratosis, or superficial basal cell carcinoma.
• Aldara Cream should not be used until your skin has healed from other treatments.

Is this medicine FDA approved?

• Imiquimod obtained the first FDA approval for it in 1997 as a treatment for external genital and perianal warts under the brand, "Aldara".
• In 2004, Imiquimod obtained FDA approval to market imiquimod as a treatment for superficial basal cell carcinoma.

How should this medicine be used?

Recommended dosage: For Actinic keratosis (AK):

• 2 times per week for a full 16 weeks.

For Superficial basal cell carcinoma (sBCC):

• 5 times per week for a full 6 weeks.

For External genital warts (EGW):

• 3 times per week until total clearance or a maximum of 16 weeks.

Administration:

• Aldara Cream is for skin use only. Do not take by mouth or use in or near your eyes, lips, or nostrils.
• Aldara Cream is used for several skin conditions. Use Aldara Cream only on the area of your body to be treated. Your healthcare provider will tell you where to apply Aldara Cream and how often and for how long to apply it for your condition. Do not use Aldara Cream longer than prescribed. Using too much Aldara Cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effect.
• For external genital and perianal warts, Aldara Cream is usually used once a day for 3 days a week. For these conditions, Aldara Cream is usually left on the skin for 6 to 10 hours. Treatment should continue until the warts are completely gone, or up to 16 weeks.
• For actinic keratosis, Aldara Cream is usually used once a day for 2 days a week, 3 to 4 days apart. For this condition, Aldara Cream is usually left on the skin for about 8 hours. Treatment should continue for the full 16 weeks.
• For superficial basal cell carcinoma, Aldara Cream is usually used once a day for 5 days a week. For this condition, Aldara Cream is usually left on the skin for about 8 hours.
• Aldara Cream should be applied just before your bedtime.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream, 5% is supplied in single-use packets (12 per box), each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod.

This medicine is available in fallowing brand namesː

• Aldara

What side effects can this medication cause?

The most common side effects of this medicine include:

• redness
• swelling
• a sore, blister, or ulcer
• skin that becomes hard or thickened
• skin peeling
• scabbing and crusting
• itching
• burning
• changes in skin color that do not always go away

• Other side effects of Aldara Cream include headache, back pain, muscle aches, tiredness, flu-like symptoms, swollen lymph nodes, diarrhea, and fungal infections.

What special precautions should I follow?

• Do not cover the treated site with bandages or other closed dressings. Cotton gauze dressings are okay to use, if needed. Cotton underwear can be worn after treating the genital or perianal area.
• Do not apply Aldara Cream in or near the eyes, lips, or nostrils, or in the vagina or anus.
• Do not use sunlamp or tanning beds, and avoid sunlight as much as possible during treatment with Aldara Cream. Use sunscreen and wear protective clothing if you go outside during daylight.
• Do not have sexual contact including genital, anal, or oral sex when Aldara Cream is on your genital or perianal skin. Aldara Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy.
• Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be required.
• 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.
• Flu-like systemic signs and symptoms including malaise, fever, nausea, myalgias, and rigors may occur. Dosing interruption may be required.
• Safety and efficacy have not been established for repeat courses of treatment to the same area for actinic keratosis.
• Aldara Cream is not recommended for treatment of basal cell carcinomas (BCC) subtypes other than the superficial variant, i.e., sBCC.
• Aldara Cream has not been evaluated for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease.
• Safety and efficacy in immunosuppressed patients have not been established.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe local skin reactions
• hypotension

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.
• hypotension can be resolved following oral or intravenous fluid administration.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Aldara Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Aldara Cream has not been studied in children under 12 years old for external genital and perianal warts.
• Aldara Cream has not been studied in children under 18 years old for actinic keratosis or superficial basal cell carcinoma. Children usually do not get actinic keratosis or basal cell carcinoma.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: imiquimod
• Inactive Ingredients: benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum.

Who manufactures and distributes this medicine?

Manufactured for:

• Valeant Pharmaceuticals North America LLC
• Bridgewater, NJ USA

By: 3M Health Care Limited Loughborough, Leicestershire LE11 5SF, United Kingdom

What should I know about storage and disposal of this medication?

• Store Aldara Cream at 39° to 77°F (4° to 25°C).
• Do not freeze.
• Safely throw away Aldara Cream that is out of date or that you do not need.

• Dailymed label info on Imiquimod
• FDA Imiquimod

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