Classifications: keratolytic agent; immune response modifier; Therapeutic: immune response modifier; keratolytic
Pregnancy Category: C
5% cream in 250 mg single use packets
An immune response modifier; exact mechanism of action is unknown. Induces cytokine production, including interferon-alfa,
which may interfere with viral replication.
Does not totally eradicate HPV. Despite destruction of HPV warts, latent or subclinical HPV infection can persist, and recurrence
of visible warts is common.
Treatment of external genital and perianal warts (Condylomata acuminata), actinic keratosis on the face and scalp of immunocompetent adults, and superficial basal cell carcinoma.
Treatment of common warts.
Occlusive dressing; ocular exposure; excessive sun exposure or sunburn; UV exposure; surgery or drug treatment on affected
area; pregnancy (category C); children <12 y.
Hypersensitivity to benzyl alcohol or paraben; HIV infection; lactation
Route & Dosage
|Genital and Perianal Warts
Adult/Adolescent (>12 y): Topical Apply a thin layer to the affected areas once daily 3 times/wk just before bedtime. Wash off cream after 610 h (max:
16 wk therapy).
Adult: Topical Apply a thin layer to the affected areas once daily 2 times/wk just before sleep for 16 wk. Wash off cream after 8 h.
Superficial Basal Cell Carcinoma
Adult: Topical Apply a thin layer to the affected areas once daily 5 times/wk just before sleep for 6 wk. Wash off cream after 8 h.
- Hand washing before and after application is recommended.
- Wash treatment area with soap and water and allow to dry thoroughly (at least 10 min).
- Single-use packets contain sufficient cream to cover an area of up to 20 cm2 (approx. 8 in. by 8 in.).
- Instruct patient to apply a thin layer of cream (avoid using excessive cream), and work into area until no longer visible.
Do not occlude the application site.
- After each treatment period, remove the cream by washing the treated area with soap and water.
- Store below 25° C (77° F).
Adverse Effects (≥1%)Body as a Whole:
Fungal infections, flu-like symptoms
, myalgia. CNS:
Headache. Skin: Application site reactions, pruritus,
burning, bleeding, stinging, redness, tenderness, irritation, erythema,
edema, weeping/exudates, dry skin, scabbing/crusting, hyperkeratosis.
Minimal absorption through intact skin.
Patient & Family Education
- Uncircumcised males with warts under the foreskin: Pull back the foreskin and clean the area daily to help avoid penile
- Females should not apply cream directly into the vagina. Application to the labia may cause pain or swelling and may cause
difficulty in passing urine.
- Avoid or minimize UV light exposure (artificial and sunlight) during treatment of actinic keratosis. Wear protective clothing.
If sunburn develops, avoid using imiquimod cream until fully recovered.