Adult Dosing

Actinic keratosis [Aldara]

• Apply 2 times qwk x 16 wks
• Max: 1 pkt/application

Note:

• To be applied before bedtime and left on the skin for approximately 8 hours. The treatment area is defined as one contiguous area of approximately 25 cm² on the face or on the scalp (but not both concurrently)

Actinic keratosis [Zyclara]

• Apply qd for two 2-wk cycles separated by a 2-wk treatment-free period
• Max: 2 pkt/application

Note:

• To be applied before bedtime and left on the skin for approximately 8 hours. Neither 2-wk treatment cycle should be extended due to missed doses or rest periods

Superficial basal cell carcinoma [Aldara]

• Apply 5 times qwk x 6 wks
• Max: 1 pkt/application
• 10 mg for target tumor diameter 0.5 to <1 cm
• 25 mg for target tumor diameter =>1 to <1.5 cm
• 40 mg for target tumor diameter =>1.5 to 2 cm

• The target tumor should have a maximum diameter of 2 cm and be located on the trunk, neck, or extremities (excluding hands and feet). To be applied before bed time and left on the skin for 8 hours

External genital warts [Aldara]

• Apply 3 times qwk
• Max: 16 wks

Note:

• To be applied before bed time and left on the skin for 6-10 hours

External genital warts [Zyclara]

• Apply qd until total clearance or for up to 8 weeks
• Max: 1 pkt/application

Note:

• To be applied before bed time and left on the skin for 8 hours

Pediatric Dosing

• Safety and effectiveness for actinic keratosis and superficial basal cell carcinoma in pediatric patients have not been established
• Safety and effectiveness for external genital/perianal warts in pediatric patients <12 yrs have not been established

External genital warts [Aldara]

• >12yrs: Apply 3 times qwk
• Max: 16 wks

Note:

• To be applied before bed time and left on the skin for 6-10 hours

External genital warts [Zyclara]

• Apply qd until total clearance or for up to 8 weeks
• Max: 1 pkt/application

Note:

• To be applied before bed time and left on the skin for 8 hours

[Outline]

• Adult Dosing
• Pediatric Dosing

• Nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults (Aldara, Zyclara)
• Biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults (Aldara)
• External genital and perianal warts/condyloma acuminata in patients 12 years old or older (Aldara, Zyclara)

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Intense local inflammatory reactions including skin weeping or erosion may occur after few applications of imiquimod; discontinue the therapy if this occurs
• Therapy has the potential to worsen inflammatory conditions of the skin, including chronic graft versus host disease; therapy should not be used until the skin is completely healed from any previous drug or surgical treatment
• Discontinue therapy if flu-like signs and symptoms and local inflammatory reactions occur
• Avoid or minimize exposure to sunlight during imiquimod use because it increases susceptibility for sunburn. Advise patients with sunburn not to use therapy until fully recovered; use with caution in patients who may have considerable sun exposure
• Concomitant use with any other imiquimod products should be avoided as it may increase the risk for and severity of local skin reactions

Cautions: Use cautiously in

• Pre-existing autoimmune disorders
• Inflamed skin at site
• Photosensitivity

Supplemental Patient Information

• Advise patients not to bandage or occlude the treatment area
• Inform patients to wash the treatment area with mild soap and water approximately 8 hours following application
• Advise patients to minimize or avoid exposing the treatment area to natural or artificial sunlight and encourage them to use sunscreen
• Instruct patients to avoid sexual (genital, anal, oral) contact while the medication is on the skin

Pregnancy Category:C

Breastfeeding: It is unknown whether imiquimod is excreted in human milk. Because many drugs are excreted in human milk, manufacturer advises caution.

• CV: Chest pain, edema
• CNS: Headache, dizziness
• GI: Anorexia, nausea, diarrhea, dyspepsia
• GU: Urinary retention
• DERM: Exfoliative dermatitis, erythema multiforme, herpes simplex, carcinoma squamous, eczema, scabbing or crusting, flaking/scaling/dryness, erosion, weeping, exudate
• RESP: URTI
• EENT: Sinusitis
• LOCAL: Local inflammatory reaction, application site reaction
• MISC: Influenza-like symptoms, pain, lymphadenopathy, fatigue, pyrexia

• Immunomodulator; exact mechanism of action is unknown; probably stimulates innate and acquired immunity responses leading to inflammatory cell infiltration within the field of drug application resulting in apoptosis of diseased tissue
• Metabolism: None; CYP450: None
• Excreted in urine and feces (<1%)
• Half-life: 29 hours

US Trade Name(s)

• Aldara
• Zyclara

US Availability

imiquimod (generic)

• CRE: 5%

Aldara

• CRE: 5%

Zyclara

• CRE: 3.75%

Canadian Trade Name(s)

• Aldara
• Zyclara
• Vyloma

Canadian Availability

Aldara

• CRE: 5%

Zyclara, Vyloma

• CRE: 3.75%

UK Trade Name(s)

• Aldara

UK Availability

Aldara

• CRE: 5%

Australian Trade Name(s)

• Aldara

Australian Availability

Aldara

• CRE: 5%

[Outline]

Antimicrobials

Dermatologic Topical Agents

Anti-infectives (Other)

Infectious Disease

Dermatologic Topical Agents

Anti-infectives (Other)

Dermatologic

Dermatologic Topical Agents

Anti-infectives (Other)

Pricing data from www.DrugStore.com in U.S.A.

• Aldara 5 % CREA [Box] (MEDICIS)
  12 % = $215.99
  24 % = $425.97
• Zyclara 3.75 % CREA [Box] (MEDICIS)
  28 % = $645.99
  84 % = $1909.97
• Imiquimod 5 % CREA [Packet] (FOUGERA)
  1 % = $35.99
  3 % = $98.76

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.