Imiquimod 5% cream or 12.5mg cream (Recommendation -Grade A)
(Imiquimod 5% (or 12.5 mg cream in 0.25gm sachet) is same as 5% imiquimod is 5mg in 100 mg cream base, that means 10 mg in 200 mg cream base or 12.5 mg in 250 mg cream base or 12.5mg in 0.25gm cream in sachet) - is a patient-applied topical immunomodulatory agent, applied at bedtime 3 times weekly for up to 16 weeks; the treatment area should be washed with soap and water 6-10 hours after the application.
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Imiquimod cream treatment should continue until the clearance of visible genital or perianal/genital warts or for a maximum of 16 weeks per episode of warts.
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once a day. Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes.
Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction. A single-use sachet is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2).
Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment. Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events.
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Imiquimod is a synthetic agent with immune response modifying activity.
Imiquimod 5% cream has been used in the treatment of a variety of skin conditions, including basal cell carcinomas and actinic keratoses. Although its precise mechanism of action remains unclear, imiquimod is believed to activate immune cells by binding to the membranous toll-like receptor. This leads to the secretion of multiple cytokines, such as interferon-α, interleukin-6, and tumor necrosis factor-α, which are critical in the induction of an inflammatory response promoting wart clearance.
Imiquimod cream should be used with caution in patients with autoimmune conditions. and inflammatory conditoins. In addition, imiquimod-treated patients have been shown to have a decrease in viral load measured by HPV DNA, a decrease in messenger ribonucleic acid (mRNA) expression for markers of keratinocyte proliferation, and an increase in mRNA expression for markers of tumor suppression.
As an immune response modifier (IRM), imiquimod stimulates cytokine production, especially interferon production. Imiquimod does not cure warts, and new warts may appear during treatment. Imiquimod does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production.
For the treatment of Condylomata Acuminata, imiquimod is applied at bedtime three times per week for up to 16 weeks.
Commonly encountered local inflammatory side effects, such as itching, erythema, burning, irritation, tenderness, ulceration, and pain, have been long-standing issues with the 5% cream.
Occasionally, patients may experience systemic side effects of headaches, muscle aches, fatigue, and general malaise.
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors, the application of the cream should be stopped immediately.
external genital wart
a skin surface basal cell carcinoma
a type of skin cancer
a roughened red patch of skin called actinic keratosis
vulvar intraepithelial neoplasia
This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths.
This product is not recommended for use on children under 12 years of age
Use this medication on the skin only. Apply this medication to the affected area(s) as directed, usually just before you go to sleep for the night. If you are using the single-use packets, use a new packet for each dose. If you are using the pump, prime the pump as directed before using it for the first time.
Before applying, wash your hands and the area to be treated with mild soap and water. Dry the area well. Apply a thin layer of medication on the affected area(s) as directed and rub in. Wash your hands with soap and water after each application. Do not cover the treated area with bandages or waterproof coverings. However, you may cover the area with cotton gauze, or wear cotton underwear if treating the genital area. Leave the cream on overnight, usually for about 8 hours if treating actinic keratoses or basal cell carcinoma, or 6 to 10 hours for warts. Do not shower or bathe during this time. In the morning, wash the treated area with soap and water to remove the cream. Do not leave imiquimod cream on longer than prescribed.
When treating warts, this medication is usually applied 3 times a week for up to 16 weeks.
Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar.
Do not apply this medication in the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor right away.
Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away.
If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal.
Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur.
Rare but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.
A very serious allergic reaction to this drug is rare.
However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.
Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.
To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.
During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, and therefore they may not work as well to prevent pregnancy or spreading of HPV or HIV.
This medicine may be harmful if swallowed.
If you miss a dose, wait until the next night to apply it. Do not double the dose to catch up. Continue with your regular scheduled doses as directed.
1. Minh PPT, Thi LP, Lan AT, Van TN, Van HL, Cam VT, Gandolfi M, Feliciani C, Satolli F, Tirant M, Vojvodic A, Lotti T. Early Treatment with Imiquimod 5% Cream of Periungual Warts in Vietnam: The Poorer, the Better. Open Access Maced J Med Sci. 2019 Jan 25;7(2):214-216. doi: 10.3889/oamjms.2019.053. PMID: 30745962; PMCID: PMC6364714.