IMIQUIMOD- imiquimod cream
Taro Pharmaceutical Industries Ltd.
Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
Imiquimod Cream is indicated for the treatment of external genital and perianal warts/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)].
The safety and efficacy of Imiquimod Cream in immunosuppressed patients have not been established.
Imiquimod Cream should be used with caution in patients with pre-existing autoimmune conditions.
The efficacy and safety of Imiquimod Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
The application frequency for Imiquimod Cream is different for each indication. Imiquimod is not for oral, ophthalmic, or intravaginal use.
Imiquimod Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm × 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Imiquimod Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Imiquimod Cream should be applied to the contiguous treatment area at each application. Imiquimod Cream should be applied prior to normal sleeping hours and 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 Imiquimod Cream therapy.
It is recommended that patients wash their hands before and after applying Imiquimod Cream. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes). Contact with the eyes, lips and nostrils should be avoided.
Local skin reactions in the treatment area are common. [see Adverse Reactions (6.1, 6.5)] A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.
Imiquimod Cream is packaged in single-use packets, with 24 packets supplied per box. Patients should be prescribed no more than 36 packets for the 16-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.
Imiquimod Cream should be applied 3 times per week to external genital/perianal warts. Imiquimod Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Imiquimod Cream should be applied prior to normal sleeping hours and left on the skin for 6-10 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 Imiquimod Cream therapy. It is recommended that patients wash their hands before and after applying Imiquimod Cream. A thin layer of Imiquimod Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.
Local skin reactions at the treatment site are common [see Adverse Reactions (6.3, 6.5)]. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.
Imiquimod Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2 ; use of excessive amounts of cream should be avoided.
Imiquimod Cream, 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Imiquimod Cream is supplied in boxes of 24 packets each.
Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Imiquimod Cream and may require an interruption of dosing. [see Dosage and Administration (2) and Adverse Reactions (6)]. Imiquimod 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 Imiquimod Cream is not recommended until the skin is completely healed from any previous drug or surgical treatment.
Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered. [see Adverse Reactions (6)]
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Imiquimod Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Imiquimod Cream. Patients with sunburn should be advised not to use Imiquimod 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 Imiquimod Cream.
Imiquimod Cream shortened the time to skin tumor formation in an animal photococarcinogenicity study [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.
Safety and efficacy have not been established for Imiquimod Cream in the treatment of actinic keratosis with repeated use, i.e., more than one treatment course, in the same area.
The safety of Imiquimod Cream applied to areas of skin greater than 25 cm2 (e.g. 5 cm × 5 cm) for the treatment of actinic keratosis has not been established [see Clinical Pharmacology (12.3)].
Imiquimod Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.
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.
The data described below reflect exposure to Imiquimod Cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Imiquimod Cream or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks.
|Preferred Term||Imiquimod Cream (n=215)||Vehicle (n=221)|
|Application Site Reaction||71 ( 33%)||32 ( 14%)|
|Upper Resp Tract Infection||33 ( 15%)||27 ( 12%)|
|Sinusitis||16 ( 7%)||14 ( 6%)|
|Headache||11 ( 5%)||7 ( 3%)|
|Carcinoma Squamous||8 ( 4%)||5 ( 2%)|
|Diarrhea||6 ( 3%)||2 ( 1%)|
|Eczema||4 ( 2%)||3 ( 1%)|
|Back Pain||3 ( 1%)||2 ( 1%)|
|Fatigue||3 ( 1%)||2 ( 1%)|
|Fibrillation Atrial||3 ( 1%)||2 ( 1%)|
|Infection Viral||3 ( 1%)||2 ( 1%)|
|Dizziness||3 ( 1%)||1 ( <1%)|
|Vomiting||3 ( 1%)||1 ( <1%)|
|Urinary Tract Infection||3 ( 1%)||1 ( <1%)|
|Fever||3 ( 1%)||0 ( 0%)|
|Rigors||3 ( 1%)||0 ( 0%)|
|Alopecia||3 ( 1%)||0 ( 0%)|
|Included Term||Imiquimod Cream (n=215)||Vehicle (n=221)|
|Itching||44 (20%)||17 (8%)|
|Burning||13 (6%)||4 (2%)|
|Bleeding||7 (3%)||1 (<1%)|
|Stinging||6 (3%)||2 (1%)|
|Pain||6 (3%)||2 (1%)|
|Induration||5 (2%)||3 (1%)|
|Tenderness||4 (2%)||3 (1%)|
|Irritation||4 (2%)||0 (0%)|
Local skin reactions were collected independently of the adverse reaction “application site reaction” in an effort to provide a better picture of the specific types of local reactions that might be seen. The most frequently reported local skin reactions were erythema, flaking/scaling/dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.
|Imiquimod Cream (n=215)||Vehicle (n=220)|
|All Grades *||Severe||All Grades *||Severe|
|Erythema||209 (97%)||38 (18%)||206 (93%)||5 (2%)|
|Flaking/Scaling/Dryness||199 (93%)||16 (7%)||199 (91%)||7 (3%)|
|Scabbing/Crusting||169 (79%)||18 (8%)||92 (42%)||4 (2%)|
|Edema||106 (49%)||0 (0%)||22 (10%)||0 (0%)|
|Erosion/Ulceration||103 (48%)||5 (2%)||20 (9%)||0 (0%)|
|Weeping/Exudate||45 (22%)||0 (0%)||3 (1%)||0 (0%)|
|Vesicles||19 (9%)||0 (0%)||2 (1%)||0 (0%)|
The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions. Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. Of the 215 subjects treated, 35 subjects (16%) on Imiquimod Cream and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Imiquimod Cream subjects, 32 (91%) resumed therapy after a rest period.
In the AK studies, 22 of 678 (3.2%) of Imiquimod-treated subjects developed treatment site infections that required a rest period off Imiquimod Cream and were treated with antibiotics (19 with oral and 3 with topical).
Of the 206 Imiquimod subjects with both baseline and 8-week post-treatment scarring assessments, 6 (2.9%) had a greater degree of scarring scores at 8-weeks post-treatment than at baseline.
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