Imiquimod

Imiquimod is a prescription medication used to treat skin conditions such as actinic keratosis, superficial basal cell carcinoma, and external genital warts.

Imiquimod is available under the following different brand names: Aldara and Zyclara.

Adult and Pediatric dosages:

Topical cream

• 2.5% (Zyclara) (adults only)
• 3.75% (Zyclara)
• 5% (Aldara)

Dosage Considerations – Should be Given as Follows:

Actinic Keratosis

• Indicated for topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults
• Zyclara 2.5% or 3.75%: Apply daily to skin of affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by 2-week no-treatment period
• Aldara 5%: Apply 2 times a week for 16 weeks to one defined treatment area (contiguous area less than 25 cm²); examples of dosing schedules include Monday and Thursday or Tuesday and Friday

External Genital Warts

Adults:

• Indicated for the treatment of external genital and perianal warts/condyloma acuminate
• Zyclara 3.75%: Apply as thin film to entire treatment area and rub in until cream is no longer visible; may wash with mild soap and water after 8 hours of application; use 1 packet or 1 full actuation of pump
• Aldara 5%: Apply 3 times a week until total clearance of warts or for a maximum of 16 weeks; examples of application schedules are Monday, Wednesday, Friday or Tuesday, Thursday, Saturday; use 1 packet only for each application

Pediatric:

• Indicated for the treatment of external genital and perianal warts/condyloma acuminata
• Children under 12 years: Safety and efficacy not established

Children 12 years or older:

• Zyclara 3.75%: Apply as thin film to entire treatment area and rub in until cream is no longer visible; may wash with mild soap and water after 8 hours of application; use 1 packet or 1 full actuation of pump
• Aldara (5%): Apply 3 times a week until total clearance of warts or for a maximum of 16 weeks; examples of application schedules are Monday, Wednesday, Friday or Tuesday, Thursday, Saturday; use 1 packet only for each application

Administration

• External genital warts: Apply prior to normal sleeping hours and leave on skin for approximately 8 hours; then wash with mild soap and water; non-occlusive dressings such as cotton gauze/underwear may be used in management of skin reactions

Dosing Considerations

• Zyclara can be used daily on larger surface areas than Aldara
• Actinic keratosis: Do not extend specified treatment cycle due to missed doses or rest periods

Administration

• External genital warts: Apply prior to normal sleeping hours and leave on skin for approximately 6-10 hours; then wash with mild soap and water; nonocclusive dressings such as cotton gauze/underwear may be used in management of skin reactions
• Do not bandage application area
• Wash hands before and after application
• Zyclara Pump: Prime before first use only by repeatedly depressing actuator until cream is dispensed
• Avoid use in or on lips, nostrils or eyes

Common side effects of imiquimod include:

• a hardened mass or formation
• application site reaction
• back pain
• bleeding
• burning
• chest pain
• coughing
• diarrhea
• dizziness
• eczema
• fatigue
• fever
• fluid from swelling or wound
• fluid-filled cavity or sac within the body
• flu-like symptoms
• fungal infection
• hair loss
• headache
• indigestion
• infection
• irregular, rapid heartbeat (atrial fibrillation)
• irritation
• itching
• muscle pain
• pain
• redness
• scabbing/crusting
• scraping/flaking of the skin
• sinus infection
• skin cancer (squamous cell carcinoma)
• skin lesions or wound
• solid pimple or swelling of the skin
• sore throat
• stinging
• stuffy nose
• sudden feeling of cold
• swelling
• swollen lymph nodes
• tenderness
• upper respiratory tract infection
• urinary tract infection
• viral infection
• vomiting

Postmarketing

• Application Site Disorders: tingling at the application site
• Body as a Whole: skin swelling
• Cardiovascular: rapid fall in blood pressure, cardiac failure, disease of the heart muscle, fluid on the lungs, irregular heartbeats, chest pain, restriction of blood supply, heart attack (myocardial infarction), fainting
• Endocrine: thyroiditis
• Gastro-Intestinal System Disorders: abdominal pain
• Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma
• Hepatic: abnormal liver function
• Infections and Infestations: herpes simplex
• Musculo-Skeletal System Disorders: joint pain
• Neuropsychiatric: anxiety, stroke, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, muscular weakness, suicide
• Respiratory: shortness of breath
• Urinary System Disorders: protein in urine, painful urination, urinary retention
• Skin and Appendages: redness and peeling of the skin, skin eruptions, patches with darker colored skin, raised scar
• Vascular: Henoch-Schönlein purpura syndrome (inflammation and bleeding in the small blood vessels in your skin, joints, intestines and kidneys with a rash on the lower legs and buttocks)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Imiquimod has no known severe interactions with other drugs.
• Imiquimod has no known serious interactions with other drugs.
• Imiquimod has no known moderate interactions with other drugs.
• Imiquimod has no known minor interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains imiquimod. Do not take Aldara or Zyclara if you are allergic to imiquimod or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• None.

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Imiquimod?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Imiquimod?"

Cautions

• Avoid or minimize exposure to sunlight, including sunlamps; wear protective clothing.
• Do not use until skin has fully healed from previous drug or surgical treatment.
• Avoid use in patients with pre-existing autoimmune conditions.
• Safety and efficacy not established for other forms of basal cell carcinoma besides superficial basal cell carcinoma safety and efficacy not established for superficial basal cell carcinoma lesions on head, face or anogenital area.
• Dosage is different for different indications.
• Avoid sexual contact while cream is on skin.
• Aldara: Safety when applied to skin area larger than 252 cm in treatment of actinic keratosis have not been determined.
• Intense local skin reactions including skin weeping or erosion may occur after few applications; may require interruption of dosing.
• May exacerbate inflammatory skin conditions such as chronic graft versus host disease.
• Severe local inflammatory reactions of female external genitalia can lead to severe vulvar swelling, which may lead to urinary retention; dosing should be interrupted or discontinued.
• A transient increase in lesion counts may be observed during treatment.
• Not recommended for oral, ophthalmic, urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease.
• Do not use in children aged 2-12 years with viral skin infection (molluscum contagiosum) due to studies failing to demonstrate efficacy.
• Safety and efficacy not established in immunosuppressed patients or those with basal cell nevus syndrome or xeroderma pigmentosum.
• Caution in patients with pre-existing autoimmune conditions.
• Flu-like signs and symptoms may accompany or precede local skin reactions (fatigue, fever, nausea, malaise, joint pain, and chills); interrupt treatment and reassess.

Pregnancy and Lactation

• Use imiquimod during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• It is unknown if imiquimod is distributed in breast milk; use caution if breastfeeding and consult your physician.