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imiquimod (Rx)Brand and Other Names:Aldara, Zyclara

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

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

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

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 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

Dosage Forms & Strengths

topical cream

  • 3.75% (Zyclara)
  • 5% (Aldara)
more...

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.

more...
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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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Images

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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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