Imiquad Special Precautions

Local Inflammatory Reactions: Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Imiquimod Cream and may require an interruption of dosing. 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 drugs or surgical treatment.
Systemic Reactions: 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.
Ultraviolet Light Exposure: 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 photocarcinogenicity study. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure.
Unevaluated Uses: Actinic Keratosis: 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 252 cm (e.g. 5cm X 5cm) for the treatment of actinic keratosis has not been established.
Unevaluated Uses: Superficial Basal Cell Carcinoma: The safety and efficacy of Imiquimod Cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types. Imiquimod Cream is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Imiquimod Cream should have regular follow-up of the treatment site.
The safety and efficacy of treating sBCC lesions on the face, head and anogenital area have not been established.
Unevaluated Uses: External Genital Warts: Imiquimod Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.
Effects on Ability to Drive & Operate Machines: No studies on the effects on the ability to drive and use machines have been performed. From the adverse reactions noted in Adverse Reactions, it is unlikely that treatment will have any effect on the ability to drive and use machines.
Use in Children: AK and sBCC are not conditions generally seen within the pediatric population. The safety and efficacy of Imiquimod Cream for AK or sBCC in patients less than 18 years of age have not been established.
Safety and efficacy in patients with external genital/perianal warts below the age of 12 years have not been established.
Imiquimod Cream was evaluated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum (MC) (470 exposed to Imiquimod Cream; median age 5 years, range 2-12 years). Subjects applied Imiquimod Cream or vehicle 3 times weekly for up to 16 weeks. Complete clearance (no MC lesions) was assessed at Week 18. In Study 1, the complete clearance rate was 24% (52/217) in the Imiquimod Cream group compared with 26% (28/106) in the vehicle group. In Study 2, the clearance rates were 25% (60/253) in the Imiquimod Cream group compared with 28% (35/126) in the vehicle group. These studies failed to demonstrate efficacy.
Similar to the studies conducted in adults, the most frequently reported adverse reaction from 2 studies in children with molluscum contagiosum was application site reaction. Adverse events which occurred more frequently in Imiquimod Cream-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% Imiquimod Cream vs. 3% vehicle) and conjunctivitis (3% Imiquimod Cream vs. 2% vehicle).
Erythema was the most frequently reported local skin reaction. Severe local skin reactions reported by Imiquimod Cream-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/exudate (2%).
Systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive MC involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of 3 applications per week for 4 weeks. The investigator determined the dose applied, either 1,2 or 3 packets per dose, based on the size of the treatment area and the subject's weight. The overall median peak serum drug concentrations at the end of week 4 was between 0.26 and 1.06 ng/mL except in a 2-year old female who was administered 2 packets of study drug per dose, had a Cmax of 9.66 ng/mL after multiple dosing. Children aged 25 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng/mL, respectively. Children aged 6-12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng/mL, respectively.
Among the 20 subjects with evaluable laboratory assessments, the median WBC count decreased by 1.4*109/L and the median absolute neutrophil count decreased by 1.42*109/L.
Use in Elderly: Of the 215 subjects treated with Imiquimod Cream in the AK clinical studies, 127 subjects (59%) were 65 years and older, while 60 subjects (28%) were 75 years and older. Of the 185 subjects treated with Imiquimod Cream in the sBCC clinical studies, 65 subjects (35%) were 65 years and older, while 25 subjects (14%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. No other clinical experience has identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.