ZYCLARA- imiquimod cream
Bausch Health US, LLC
ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].
Treatment with ZYCLARA Cream has not been studied for prevention or transmission of human papillomavirus (HPV).
The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:
- urethral, intravaginal, 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.
For topical use only; ZYCLARA Cream is not for oral, ophthalmic, intra-anal or intravaginal use.
ZYCLARA Cream should be applied once daily before bedtime to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. ZYCLARA Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (two packets or two full actuations of the pump) of ZYCLARA Cream may be applied to the treatment area at each application. ZYCLARA Cream should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Avoid use in or on the lips and nostrils. Do not use in or near the eyes.
Local skin reactions in the treatment area are common [see Adverse Reactions (6.1)]. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in lesion counts may be observed during treatment. Response to treatment cannot be adequately assessed until resolution of local skin reactions. The patient should continue dosing as prescribed. Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.
Prescribe no more than 2 boxes (56 packets) or two 7.5 g pumps for the total 2-cycle treatment course. Partially used packets should be discarded and not reused.
Patients should apply a thin layer of ZYCLARA Cream once a day to the external genital/perianal warts until total clearance or for up to 8 weeks. Patients should use up to 0.25 grams (one packet or one full actuation of the pump) at each application, which is a sufficient amount of cream to cover the wart area. ZYCLARA Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, then removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Local skin reactions at the treatment site are common [see Adverse Reactions (6.2)] , and may necessitate a rest period of several days; resume treatment once the reaction subsides. Non-occlusive dressings, such as cotton gauze or cotton underwear, may be used in the management of skin reactions.
Prescribe up to 2 boxes (56 packets) or two 7.5 g pumps for the total treatment course. Use of excessive amounts of cream should be avoided. Partially used packets should be discarded and not reused.
ZYCLARA (imiquimod) Cream pumps should be primed before using for the first time by repeatedly depressing the actuator until cream is dispensed. It is not necessary to repeat this priming process during treatment.
ZYCLARA Cream, 2.5% is a white to faintly yellow cream available in pump bottles. Each pump bottle, when actuated after priming, delivers 0.235 grams of cream.
ZYCLARA Cream, 3.75% is a white to faintly yellow cream available in single-use packets and pump bottles. Each packet administers 0.25 grams of cream and each pump bottle, when actuated after priming, delivers 0.235 grams of cream (a similar amount as one packet).
Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing [see Dosage and Administration (2) and Adverse Reactions (6)]. ZYCLARA Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling.
Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.
Flu-like signs and symptoms may accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, malaise, and chills. An interruption of dosing and an assessment of the patient should be considered [see Adverse Reactions (6)].
Lymphadenopathy occurred in 2% of subjects with actinic keratosis treated with ZYCLARA Cream, 3.75% and in 3% of subjects treated with ZYCLARA Cream, 2.5% [see Adverse Reactions (6)]. This reaction resolved in all subjects by 4 weeks after completion of treatment.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCLARA Cream. Patients should be warned to use protective clothing (e.g., a hat) when using ZYCLARA Cream. Patients with sunburn should be advised not to use ZYCLARA Cream until fully recovered. Patients who may have considerable sun exposure (e.g., due to their occupation) and those patients with inherent sensitivity to sunlight should exercise caution when using ZYCLARA Cream.
In an animal photocarcinogenicity study, imiquimod cream shortened the time to skin tumor formation [see Nonclinical Toxicology (13.1)]. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure.
Concomitant use of ZYCLARA Cream and any other imiquimod products, in the same treatment area, should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions.
The safety of concomitant use of ZYCLARA Cream and any other imiquimod products has not been established and should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of systemic reactions.
ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells [see Clinical Pharmacology (12.2)].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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