imiquimod

REMS

External genital or perianal warts/condylomata (condyloma acuminatum).
Typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp.
Biopsy-confirmed, primary superficial basal cell carcinoma (5% cream only).

Action ⬆ ⬇

May induce the formation of interferons that have antiproliferative and antiviral properties.

Therapeutic effects:

Regression of external genital or perianal warts/condylomata, actinic keratoses, or basal cell carcinoma lesions.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal absorption.

Distribution: Action is primarily local.

Metabolism/Excretion: <0.9% excreted in urine and feces.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(regression of lesions)

ROUTE	ONSET	PEAK	DURATION
Topical	days–wk	10–16 wk	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Previous treatment/surgery in affected area (area should be healed prior to use);
Pre-existing inflammatory skin lesions (may be exacerbated);
Immunocompromised patients (safety not established);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children 18 yr (for actinic keratoses) or 12 yr (for other indications).

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea, nausea

GU: dysuria, vulvar swelling

Local: irritation, pain, pruritus, burning, swelling, fungal infections (women)

Neuro: dizziness, fatigue, headache

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

External Genital Warts

(Adults and Children ≥12 yr): 5% cream: Apply thin layer to warts at bedtime every other day (3 times weekly); leave on for 6–10 hr, then rinse off with mild soap and water. Use until lesions are completely cleared or up to 16 wk. Zyclara: Apply thin layer of 3.75% cream to warts at bedtime every day; leave on for 8 hr, then rinse off with mild soap and water. Use until lesions are completely cleared or up to 8 wk.

Actinic Keratoses

(Adults ): 5% cream: Apply thin layer to clean, dry affected area twice weekly; leave on for 8 hr, then rinse off with mild soap and water. Continue for 16 wk. Zyclara: Apply thin layer of 2.5% or 3.75% cream to clean, dry affected area once daily before bedtime; leave on for 8 hr, then rinse off with mild soap and water. Continue for 2 wk, followed by 2 wk without treatment, then begin applying cream again for another 2 wk.

Superficial Basal Cell Carcinoma

(Adults ): Apply thin layer to clean, dry affected area 5 times per week; leave on for 8 hr, then rinse off with mild soap and water. Continue for 6 wk.

Availability ⬆ ⬇

(Generic available)

Cream: 2.5% (pump bottles) (Zyclara); 3.75% (single-use packets and pump bottles) (Zyclara); 5% (single-use packets)

Assessment ⬆ ⬇

Assess affected area(s) prior to and periodically during therapy.

Implementation ⬆ ⬇

Apply a thin film to clean and dry skin as directed prior to bedtime. Rub in well and leave on skin for time period specified. Remove by washing with mild soap and water. Discard unused cream from single-dose packet. A rest period of several days may be taken if required for patient comfort or severity of skin reaction. Resume therapy when reaction subsides.
- Do not use occlusive dressings. If covering is needed, use cotton gauze or cotton underclothes.

Patient/Family Teaching ⬆ ⬇

Instruct patient on proper application technique. Emphasize the importance of washing hands before and after application and avoiding contact with eyes. Advise patient not to use more cream than was prescribed. Missed doses should be applied as soon as possible; then return to regular schedule.
Advise patient to delay next dose for several days when experiencing discomfort or severe reactions. Notify health care professional if severe reactions occur.
Advise patient to avoid sharing this medication with others.
Instruct patient to avoid contact with affected areas while the cream is on the skin. Wash cream off of genital areas before engaging in sexual activities. Inform patient that oils in the cream weaken latex contraceptive devices, such as cervical caps, condoms, and diaphragms.
Advise patient to avoid use of other topical medications on same treatment area unless recommended by health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇