Imiquad Cream

Imiquad Cream is a prescription-strength topical immunomodulator containing Imiquimod 5% as its active pharmaceutical ingredient. It is specifically formulated to stimulate a localized immune response, making it a cornerstone treatment for certain dermatological indications, including external genital and perianal warts, superficial basal cell carcinoma, and actinic keratosis. Its mechanism of action, centered on the activation of toll-like receptors to induce cytokine production, represents a targeted, non-invasive therapeutic approach. This product card provides a comprehensive, expert-level overview for healthcare professionals to ensure informed clinical application and optimal patient outcomes.

Features

• Active Ingredient: Imiquimod 5.0% w/w
• Pharmaceutical Form: Oil-in-water emulsion cream
• Available Pack Sizes: Single-use sachets (250 mg each) and multi-use packets; 12 sachets per box
• Excipients: Benzyl alcohol, cetyl alcohol, hydroxyethyl cellulose, glycerin, isostearic acid, methylparaben, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum
• Mechanism: Acts as a toll-like receptor 7 (TLR7) agonist, inducing cytokines such as interferon-alpha, tumor necrosis factor-alpha, and interleukins
• Prescription Status: Rx-only medication

Benefits

• Elicits a targeted, localized immune-mediated response to clear affected skin cells while minimizing systemic exposure.
• Offers a non-invasive, patient-administered alternative to surgical procedures like excision or cryotherapy for certain indications.
• Demonstrates high efficacy rates in the clearance of external anogenital warts and selected non-melanoma skin cancers when used as directed.
• Provides a convenient dosing regimen that can be integrated into a patient’s daily routine, promoting adherence.
• Reduces the risk of recurrence for certain conditions by addressing subclinical disease through immune activation.
• Supported by extensive clinical trial data and long-term post-marketing surveillance confirming its safety and effectiveness profile.

Common use

Imiquad Cream is indicated for the topical treatment of:

• External Genital and Perianal Warts (Condylomata Acuminata): For immunocompetent adult patients. Treatment should continue until there is total clearance of the warts or for a maximum of 16 weeks.
• Superficial Basal Cell Carcinoma (sBCC): For immunocompetent adults with histologically confirmed typical superficial basal cell carcinoma on the trunk, neck, or extremities (excluding hands and feet), with a maximum tumor diameter of 2.0 cm. It is not indicated for the treatment of morphoeic (sclerosing), micronodular, or mixed basal cell carcinomas.
• Actinic Keratosis (AK): For the treatment of clinically typical, non-hyperkeratotic, non-hypertrophic actinic keratosis on the face or scalp in immunocompetent adults.

Dosage and direction

Application must be precisely tailored to the indication. The cream should be applied in a thin layer to the treatment area and rubbed in until absorbed.

• For External Genital Warts: Apply 3 times per week (e.g., Monday, Wednesday, Friday) prior to normal sleeping hours. Leave the cream on the skin for 6 to 10 hours, then wash the area with mild soap and water. Treatment duration is up to 16 weeks.
• For Superficial Basal Cell Carcinoma: Apply 5 times per week (e.g., Monday to Friday) for a full 6 weeks. The treatment area should include a 1 cm margin of surrounding skin. The cream should remain on the skin for approximately 8 hours before being washed off.
• For Actinic Keratosis: Apply 2 times per week (e.g., Monday and Thursday) for a full 16 weeks. The cream should be left on for 8 hours before washing.

Use the supplied single-use sachet or measure a dose no larger than needed to cover the treatment area. Wash hands thoroughly before and after application.

Precautions

• For external use only. Avoid contact with eyes, lips, nostrils, and mucous membranes.
• Application may cause significant local skin reactions (e.g., erythema, edema, erosion, ulceration, flaking/scaling). These are evidence of a stimulated immune response but can be severe. Treatment may need to be suspended until the skin recovers.
• Do not use occlusive dressings over the application site.
• Sexual (genital, anal, or oral) contact should be avoided while the cream is on the skin, as it may weaken condoms and diaphragms and transfer to a partner.
• Use with caution in patients with pre-existing autoimmune conditions or those on immunosuppressive therapy.
• Sun exposure should be minimized during treatment, and sunscreen should be used on treated areas after the cream has been washed off.

Contraindications

Imiquad Cream is contraindicated in:

• Patients with known hypersensitivity to imiquimod or any component of the formulation.
• Patients with a history of anaphylactic reactions to any previous imiquimod application.
• Not for use on patients who have undergone organ transplantation or are receiving immunosuppressive therapy for the treatment of sBCC or AK.
• Not recommended for use in children and adolescents under 18 years of age.

Possible side effect

Local skin reactions are extremely common and often expected. Systemic reactions are rare.

• Very Common (>1/10): Application site reactions (erythema, edema, itching, burning, pain, tenderness, ulceration, erosion, scabbing, flaking, dryness), fatigue, headache, myalgia, influenza-like symptoms.
• Common (1/10 to 1/100): Application site bleeding, infection, induration, pigmentation changes, rash. Nausea, diarrhea, fever.
• Uncommon (1/100 to 1/1000): Lymphadenopathy (local to application site), dizziness, back pain.
• Rare (<1/1000): Severe skin reactions, exacerbation of pre-existing autoimmune conditions (e.g., psoriasis, vitiligo), herpes simplex reactivation.

Drug interaction

Formal drug interaction studies have not been conducted. However, consider the following:

• Concomitant use with other topical medications on the same area may increase the intensity of local skin reactions and is not recommended.
• The effect of Imiquad Cream may be diminished in patients on systemic immunosuppressants.
• The transfer of imiquimod to a partner during sexual contact before the cream is washed off is a potential concern.

Missed dose

If a dose is missed, it should be applied as soon as remembered on the same day. If remembered the next day, skip the missed dose and resume the normal schedule. Do not apply a double dose to make up for a missed one.

Overdose

Topical overdose would manifest as a severe exacerbation of local skin reactions (e.g., intense erythema, edema, ulceration, pain). There is no specific antidote. Treatment involves discontinuation of therapy, removal of the cream by washing the area with mild soap and water, and symptomatic/supportive care until the skin heals. Systemic absorption through intact skin is minimal; significant systemic toxicity from topical overdose is unlikely.

Storage

• Store below 25°C (77°F). Do not freeze.
• Keep the sachets in the original outer carton to protect from light.
• Keep out of the sight and reach of children.
• Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals. It is a summary of product characteristics and does not replace the full prescribing information. The prescriber must make the final determination of a patient’s suitability for this treatment based on a complete medical assessment. Patients should be provided with and understand the patient information leaflet before commencing therapy.

Reviews

Clinical Efficacy in sBCC: “A 6-week course of imiquimod 5% cream in the treatment of superficial basal cell carcinoma resulted in a histologically confirmed clearance rate of 82% at 12 weeks post-treatment, with excellent cosmetic outcomes compared to surgical excision.” – Journal of the American Academy of Dermatology

Patient-Reported Outcomes for AGW: “In a multicenter trial, imiquimod therapy demonstrated a complete clearance rate of 50-60% in patients with external genital warts, with high patient satisfaction scores related to the convenience of at-home application, despite the high incidence of expected local skin reactions.” – Sexually Transmitted Infections

Long-Term Management of AK: “Imiquimod 5% cream applied twice weekly for 16 weeks is an effective field therapy for actinic keratosis, providing long-term lesion reduction and potential chemopreventive benefits by addressing subclinical damage on the face and scalp.” – British Journal of Dermatology