Imiquimod (imiquimod)

Because of the potential for adverse local reactions (e.g., erythema, erosion, excoriation/flaking, edema), the recommended dose, frequency of application, and duration of treatment of topical imiquimod should not be exceeded; use of excessive amounts of the cream should be avoided. Topical imiquimod therapy may be temporarily discontinued for several days if required because of the patient's discomfort or severity of local reactions, and then reinitiated after the reactions subside. However, the total duration of treatment should not be extended beyond the maximum recommended duration (i.e., 16 weeks for treatment of actinic keratosis, 6 weeks for treatment of superficial basal cell carcinoma, 16 weeks for treatment of genital and perianal HPV warts).

Imiquimod is applied topically as a 5% cream.

The topical cream is for external use only. Contact with the eyes, lips, and nostrils should be avoided and the drug should not be administered orally, intravaginally, or intra-anally.

Imiquimod is suitable for self-administration. Prior to initial use, patients should be instructed regarding proper techniques for application and removal of the drug.

Patients should be directed to wash their hands before and after applying imiquimod cream. Prior to application, the affected area should be washed with mild soap and water and allowed to dry thoroughly (at least 10 minutes). Immediately prior to normal sleeping hours (bedtime) on treatment days, the cream should be applied to the entire treatment area and rubbed in until no longer visible. The cream should be allowed to remain on the skin for approximately 8 hours (6-10 hours) and removed the following morning by washing with mild soap and water.

When the drug is used for the treatment of genital HPV warts, uncircumcised males should be advised to clean under the foreskin before treatment and once daily during treatment and females should be advised to avoid intravaginal application and take special care when applying near the vaginal opening since local reactions at this site may result in pain or swelling and difficult urination.

Use of imiquimod should be delayed until skin has healed from any previous sunburn or drug or surgical treatment.

Occlusive dressings or wrappings should not be used.

Imiquimod cream is supplied in single-use packets containing 250 mg of cream (12.5 mg of imiquimod). When treating actinic keratosis, no more than 1 packet of the cream should be applied to the contiguous treatment area. When treating external genital or perianal human papillomavirus (HPV) warts, 1 packet of cream should be sufficient to cover a wart area up to 20 cm2. Partially used packets should be discarded and should not be reused.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

• Graft-versus-host disease
• Skin photosensitivity
• Sunburn

• Autoimmune disease
• Immunosuppression

There is no enhanced messaging for this drug.

More Frequent

• Blistering skin
• Fungal infection
• Skin crusting
• Superficial skin ulcer

Less Frequent

• Severe erythema
• Squamous cell carcinoma
• Tinea cruris

Rare or Very Rare

• Abnormal hepatic function tests
• Acute myocardial infarction
• Agitation
• Angioedema
• Arthralgia
• Bone marrow depression
• Depression
• Dyspnea
• Dysuria
• Flu-like symptoms
• Heart failure
• IgA vasculitis
• Insomnia
• Malignant lymphoma
• Proteinuria
• Syncope
• Thyroiditis
• Urinary retention

More Frequent

• Erythema
• Induration of skin
• Pruritus of skin
• Skin inflammation
• Skin rash
• Skin swelling
• Stinging of skin
• Treatment site sequelae
• Upper respiratory infection

Less Frequent

• Back pain
• Diarrhea
• Dry skin
• Edema
• Fatigue
• Fever
• Headache disorder
• Skin hypopigmentation
• Skin photosensitivity

Rare or Very Rare

• Abdominal pain with cramps
• Alopecia
• Chills
• Dizziness
• Eczema
• Herpes simplex infection
• Sinusitis
• Vomiting
• Vulvar edema

No enhanced messaging available.

No enhanced messaging available.

There was no evidence of embryotoxicity or teratogenicity when oral imiquimod was used in rats and rabbits at dosages 98 times the maximum recommended human dose (MRHD) (based on area under the plasma concentration-time curve (AUC) comparisons) or when IV imiquimod was used in rabbits at dosages 407 times the MRHD (based on AUC) or 1.5 times the MRHD (based on body surface area). When oral imiquimod dosages 577 times the MRHD (based on AUC) were used in rats, maternal toxicity occurred and adverse fetal effects included increased resorptions, decreased fetal body weight, delayed skeletal ossification, bent limb bones, and exencephaly, protruding tongues, and low-set ears. There are no adequate and controlled studies using imiquimod in pregnant women, and the drug should be used during pregnancy only when clearly needed.

It is not known whether topically applied imiquimod is distributed into human milk. The drug should be used with caution in nursing women.

No enhanced messaging available.