imiquimod (Rx)

Brand and Other Names:Aldara, Zyclara
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

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

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 qDay 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 <25 cm²); examples of dosing schedules include Monday and Thursday or Tuesday and Friday

Superficial Basal Cell Carcinoma

Target tumor should have maximum <2 cm diameter and be located on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet); treatment area should include 1 cm margin of skin around tumor

Aldara 5%: Apply 5 times a week for 6 weeks to biopsy-confirmed superficial basal cell carcinoma and include 1 cm margin of skin around tumor

External Genital Warts

Indicated for the treatment of external genital and perianal warts/condyloma acuminata

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

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

Bladder Cancer (Orphan)

Orphan designation for treatment of carcinoma in situ of the urinary bladder

Sponsor

  • Telormedix SA; Via della Posta 10, CH-6934 Bioggio; SWITZERLAND

Melanoma (Orphan)

Imiquimod plus monobenzone: Orphan designation for treatment of state IIB-IV melanoma

Sponsor

  • Learmont Pharmaceuticals, Inc; 233 Broadway, Suite 1750; New York, New York 10279

Dosage Forms & Strengths

topical cream

  • 3.75% (Zyclara)
  • 5% (Aldara)

External Genital Warts

Indicated for the treatment of external genital and perianal warts/condyloma acuminata

<12 years: Safety and efficacy not established

≥12 years

  • 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 hr; then wash with mild soap and water; non-occlusive dressings such as cotton gauze/underwear may be used in management of skin reactions

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Adverse Effects

>10%

Application site reaction (33%)

URTI (15%)

Erythema (54-61%)

Erosion (29-31%)

Excoriation/flaking (18-25%)

Edema (12-17%)

Itching (20%)

1-10%

Sinusitis (7%)

Burning (6%)

Headache (5%)

Carcinoma squamous (4%)

Diarrhea (3%)

Bleeding (3%)

Stinging (3%)

Pain (3%)

Eczema (2%)

Induration (2%)

Tenderness (2%)

Irritation (2%)

Back pain (1%)

Fatigue (1%)

Atrial fibrillation (1%)

Viral infection (1%)

Dizziness (1%)

Vomiting (1%)

UTI (1%)

Fever (1%)

Rigor (1%)

Alopecia (1%)

Frequency Not Defined

Headache

Flu-like symptoms

Myalgia

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Warnings

Contraindications

None

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 BCC besides sBCC Safety and efficacy not established for sBCC 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 >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, ophtalmic, urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease

Do not use in children aged 2-12 years with 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 (eg, fatigue, fever, nausea, malaise, arthralgias, chills); interrupt treatment and reassess

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if distributed in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Unknown mechanism in treating actinic keratosis and external genital warts; immune response modifier, stimulates release of inflammatory cytokines and proliferation/migration of immune cells

No direct antiviral activity

Absorption

Appears to be dependent on area of application rather than amount applied

Peak plasma concentration (Aldara): 0.1-3.5 ng/mL

Peak plasma concentration (Zyclara): 0.323 ng/mL

Elimination

Excretion: Urine

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Administration

Topical Administration

External genital warts: Apply prior to normal sleeping hours and leave on skin for approximately 6-10 hr; 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

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
imiquimod topical
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5 % cream
Aldara topical
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5 % cream
Zyclara topical
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3.75 % cream
Zyclara topical
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2.5 % cream
Zyclara topical
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3.75 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
imiquimod topical

IMIQUIMOD - TOPICAL

(im-I-kwi-mod)

COMMON BRAND NAME(S): Aldara

USES: This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths.This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using imiquimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication on the skin only. Apply this medication to the affected area(s) as directed by your doctor, usually just before you go to sleep for the night. If you are using the single-use packets, use a new packet for each dose. If you are using the pump, prime the pump as directed before using it for the first time.Before applying, wash your hands and the area to be treated with mild soap and water. Dry the area well. Apply a thin layer of medication on the affected area(s) as directed and rub in. Wash your hands with soap and water after each application. Do not cover the treated area with bandages or waterproof coverings. However, you may cover the area with cotton gauze, or wear cotton underwear if treating the genital area. Leave the cream on overnight, usually for about 8 hours if treating actinic keratoses or basal cell carcinoma, or 6 to 10 hours for warts. Do not shower or bathe during this time. In the morning, wash the treated area with soap and water to remove the cream. Do not leave imiquimod cream on longer than prescribed.The dosage and length of treatment is based on your medical condition and response to treatment. When treating actinic keratoses, this medication is usually applied twice a week for 16 weeks. When treating superficial basal cell carcinoma, this medication is usually applied 5 times a week for 6 weeks. When treating warts, this medication is usually applied 3 times a week for up to 16 weeks. Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar.Do not apply this medication in the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor right away.Tell your doctor if your condition lasts or gets worse, or if new growths appear during treatment.

SIDE EFFECTS: Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal. Follow your doctor's directions.Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using imiquimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/unhealed surgery on the skin area to be treated, immune system problems (including HIV infection), a certain complication of bone marrow or some organ transplants (chronic graft-versus-host disease), autoimmune diseases (such as rheumatoid arthritis, scleroderma, lupus).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, so they may not work as well to prevent pregnancy or spreading of HPV or HIV.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Keep all medical appointments.

MISSED DOSE: If you miss a dose, wait until the next night to apply it. Do not double the dose to catch up. Continue with your regular scheduled doses as directed.

STORAGE: Store the US product in the refrigerator or at room temperature. Store the Canadian product at room temperature. Do not freeze. Discard any medication that has been frozen. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.