Usual Adult Dose for Keratosis

2.5% and 3.75% cream: Apply a thin film once a day before bedtime to the affected area (either entire face or balding scalp)

Comments:

• Treatment should continue for two 2-week treatment cycles separated by a 2-week no treatment period.
• Cream should be applied as a thin film to the entire treatment area and rubbed in until it is no longer visible.
• Up to 2 packets or 2 pump actuations may be applied per application.
• To be left on the skin for about 8 hours, after which, to be removed with mild soap and water.

5% cream: Apply topically to the affected area on the face or scalp (but not both concurrently) 2 times per week for a full 16 weeks

Comments:

• The treatment area is defined as one contiguous area of about 5 cm by 5 cm on the face (e.g., forehead or 1 cheek) or on the scalp.
• Examples of a schedule of 2 times per week are Monday and Thursday, or Tuesday and Friday.
• Cream should be applied to the entire treatment are and rubbed in until it is no longer visible.
• Not more than 1 packet should be applied to the contiguous treatment are at each application.
• To be applied prior to normal sleeping hours and left on the skin for about 8 hours, after which, to be removed with mild soap and water.

Use: For topical treatment of clinically typical visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent patients

Usual Adult Dose for Condylomata Acuminata

3.75% cream: Apply a thin layer once a day to the external genital/perianal warts until total clearance or up to 8 weeks

Comments:

• Up to 1 packet or 1 full actuation of the pump of cream may be use at the treatment site for each application.
• To be applied prior to normal sleeping hours and left on the skin for about 8 hours, then removed by washing the area with mild soap and water.
• Nonocclusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reaction

5% cream: Apply topically to external genital/perianal warts 3 times per week

Comments:

• Treatment should continue until there is total clearance of warts or up to a maximum of 16 weeks.
• Examples of 3 times per week application schedules are Monday, Wednesday, Friday or Tuesday, Thursday, and Saturday.
• To be applied prior to normal sleeping hours and left on the skin for 6 to 10 hours, then removed by washing the area with mild soap and water.

Use: For the treatment of external genital and perianal warts (EGW)/condyloma acuminate

Usual Adult Dose for Basal Cell Carcinoma

5% cream: Apply topical to a biopsy-confirmed superficial basal cell carcinoma 5 times per week for a full 6 weeks

Comments:

• To be applied prior to normal sleeping hours and left on the skin for about 8 hours, then removed by washing the area with mild soap and water.
• The treatment area should include a 1 cm margin of skin around the tumor.
• Sufficient cream should be used to cover the treatment area and rubbed in until it is no longer visible.

Use: For the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured

Usual Pediatric Dose for Condylomata Acuminata

12 years or older:
3.75% cream: Apply a thin layer once a day to the external genital/perianal warts until total clearance or up to 8 weeks

Comments:

• Up to 1 packet of cream may be use at the treatment site for each application.
• To be applied prior to normal sleeping hours and left on the skin for about 8 hours, then removed by washing the area with mild soap and water.

12 years or older:
5% cream: Apply topically to external genital/perianal warts 3 times per week

Comments:

• Treatment should continue until there is total clearance of warts or up to a maximum of 16 weeks.
• Examples of 3 times per week application schedules are Monday, Wednesday, Friday or Tuesday, Thursday, and Saturday.
• To be applied prior to normal sleeping hours and left on the skin for 6 to 10 hours, then removed by washing the area with mild soap and water.

Use: For the treatment of external genital and perianal warts (EGW)/condyloma acuminate

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 12 years for the treatment of external genital warts.

Safety and efficacy have not been established in patients younger than 18 years for the treatment of actinic keratosis or superficial basal cell carcinoma.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For topical use only; not for oral, ophthalmic, intra-anal, or intravaginal use.
• Wash hands before and after use.
• Avoid use in or on lips and nostril; do not use in or near the eyes.
• Use of excessive amount of cream should be avoided and partially used packets discarded and not reused.
• The pump should be primed before first time use by repeatedly depressing the actuator until the cream is dispensed; it is not necessary to repeat priming process.
• Local skin reactions are common in all treatment areas; a rest period of several days may be taken if required by patient's discomfort or severity of the reaction; however, neither 2-week treatment cycle when treating actinic keratosis should be extended due to missed doses or rest periods.
• A transient increase in lesion counts may be observed during treatment of actinic keratosis; response to treatment cannot be adequately assessed until resolution of local skin reactions.
• Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone; carefully re-evaluate patient if lesions that do not respond to treatment.

Storage requirements:

• Avoid freezing.
• Store pump upright.

General:

• This drug has not been evaluated in children 2 to 12 years with molluscum contagiosum.
• Treatment has not been studied for prevention or transmission of human papilloma virus (HPV).
• The safety and efficacy have not been established in the treatment of: urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease; actinic keratosis when treated with more than one 2-cycle treatment course in the same area; patients with xeroderma pigmentosum; superficial basal cell carcinoma; immunosuppressed patients.

Patient advice:

• Wash hands before and after use.
• Consult the patient information leaflet for further information.

Frequently asked questions

• What are the most common skin conditions? (with photos)
• Does duct tape really remove warts?
• Is imiquimod the same as Aldara?
• What are the side effects of the HPV vaccine?
• Does Zyclara work for genital warts?
• Who makes Zyclara and where is it manufactured?