Imiquimod

• Basal cell carcinoma

Imiquimod cream is indicated for the topical treatment of- External genital and perianal warts in adults. Small superficial basal cell carcinomas in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

N/A

Imiquimod cream is contraindicated in patients with hypersensitivity to imiquimod or cream excipients.

Imiquimod is a toll-like receptor-7 agonist enhancing both the innate and acquired immune response. It activates the production of numerous compounds, including IFN-α, IL-1, -6, -8, -10, -12, and TNF-α, stimulates natural killer cells and the proliferation of B-cells. It also activates Langerhans cells and promotes their migration to the regional lymph nodes. Imiquimod stimulates TH-1 cells to produce IFN-g, which in turn can activate cytotoxic T lymphocytes. These cells provide long-term immune memory, which can offer future protection against the previously encountered virus or tumor.

No interaction studies have been performed. This includes studies with immunosuppressive drugs. Interactions with systemic drugs would be limited by the minimal percutaneous absorption of Imiquimod cream. Due to its immunostimulating properties, Imiquimod cream should be used with caution in patients who are receiving immunosuppressive medication.

Reported side effects are pustules, genital candidiasis, vaginitis, bacterial infection, fungal infection, upper respiratory tract infection, vulvitis, rhinitis, influenza, lymphadenopathy, anorexia, insomnia, depression, irritability, headache, paraesthesia, dizziness, migraine, somnolence, conjunctival irritation, eyelid oedema, tinnitus, flushing, pharyngitis, nasal congestion, pharyngo laryngeal pain, nausea, abdominal pain, diarrhoea, vomitting, rectal disorder, rectal tenesmus, dry mouth, pruritus, folliculitis, rash erythematous, eczema, rash, increased sweating, urticaria, erythema, face oedema, skin ulcer, myalgia, arthralgia, back pain, pain in extremity, dysuria, genital pain in male, penile disorder, dyspareunia, erectile dysfunction, uterovaginal prolapse, vaginal pain, vaginitis atrophic, vulval disorder, and general disorders and administration site disorders such as pruritus, pain, burning, irritation, erythema, reaction, bleeding, papules, rash, inflammation asthenia, malaise, rigors, lethargy, discomfort, fatigue, discharge, oedema, scar, ulcer, vesicle, warmth, pyrexia etc. Reports have been received of localised hypopigmentation and hyperpigmentation following Imiquimod cream use. Clinical studies investigating the use of Imiquimod for the treatment of actinic keratosis have detected a 0.4% frequency of alopecia at the treatment site or surrounding area. Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.

When applied topically, systemic overdosage with Imiquimod cream is unlikely due to minimal percutaneous absorption. Persistent dermal overdosing of Imiquimod cream could result in severe local skin reactions. Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg Imiquimod which corresponds to the content of approximately 16 sachets. The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.

Use in Pregnancy B1. No human study is available. Imiquimod cream should only be used during pregnancy, if the potential benefit justifies the potential risk of fetus. No human study is available. Imiquimod cream should only be used during lactation if the potential benefit justifies the potential risk to the new-born baby.

Hypersensitivity to the active substance or to any of the excipients.

Use in Children: Imiquimod cream is not recommended below the age of 12 years.Use in Elderly: Imiquimod cream is recommended in elderly patient.Effect on ability to drive and use machineries: Imiquimod cream is unlikely to produce any effect.