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ALDARA CREAM (IMIQUIMOD): ADVERSE REACTIONS / SIDE EFFECTS

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.

Clinical Trials Experience: Actinic Keratosis

The data described below reflect exposure to Imiquimod (Aldara) topical cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Imiquimod (Aldara) cream 5% or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks.

Selected adverse reactions occurring in > 1% of Aldara-treated subjects and at a greater frequency than with vehicle in the combined studies (actinic keratosis): application site reaction; upper resp tract infection; sinusitis; headache; carcinoma squamous; diarrhea; eczema; back pain; fatigue; fibrillation atrial; infection viral; dizziness; vomiting; urinary tract infection; fever; rigors; alopecia.

Application site reactions reported by > 1% of Aldara-treated subjects and at a greater frequency than with vehicle in the combined studies (actinic keratosis): itching; burning; bleeding; stinging; pain; induration; tenderness; irritation.

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.

Local skin reactions in the treatment area as assessed by the investigator (actinic keratosis): erythema; flaking / scaling / dryness; scabbing / crusting; edema; erosion / ulceration; weeping / exudate; vesicles.

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 Aldara and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Aldara cream subjects, 32 (91%) resumed therapy after a rest period.

In the AK studies, 22 of 678 (3.2%) of Aldara-treated subjects developed treatment site infections that required a rest period off Aldara (Imiquimod) and were treated with antibiotics (19 with oral and 3 with topical).

Of the 206 Aldara 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.

Clinical Trials Experience: Superficial Basal Cell Carcinoma

The data described below reflect exposure to Imiquimod (Aldara) or vehicle in 364 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara (Imiquimod) cream or vehicle 5 times per week for 6 weeks. The incidence of adverse reactions reported by > 1% of subjects during the studies is summarized below.

Selected adverse reactions reported by > 1% of Aldara-treated subjects and at a greater frequency than with vehicle in the combined studies (superficial basal cell carcinoma): Application Site Reaction; Headache; Back Pain; Upper Resp Tract Infection; Rhinitis; Lymphadenopathy; Fatigue; Sinusitis; Dyspepsia; Coughing; Fever; Dizziness; Anxiety; Pharyngitis; Chest Pain; Nausea.

The most frequently reported adverse reactions were local skin and application site reactions including erythema, edema, induration, erosion, flaking / scaling, scabbing / crusting, itching and burning at the application site. The incidence of application site reactions reported by > 1% of the subjects during the 6 week treatment period is summarized below.

Application site reactions reported by > 1% of Aldara-treated subjects and at a greater frequency than with vehicle in the combined studies (superficial basal cell carcinoma): itching; burning; pain; bleeding; erythema; papule(s); tenderness; infection.

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 prevalence and severity of local skin reactions that occurred during controlled studies are shown below.

local skin reactions in the treatment area as assessed by the investigator (superficial basal cell carcinoma): erythema; flaking / scaling; induration; scabbing / crusting; edema; erosion; ulceration; vesicles.

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions; 10% (19/185) of subjects received rest periods. The average number of doses not received per subject due to rest periods was 7 doses with a range of 2 to 22 doses; 79% of subjects (15/19) resumed therapy after a rest period. Overall, in the clinical studies, 2% (4/185) of subjects discontinued for local skin/application site reactions.

In the sBCC studies, 17 of 1266 (1.3%) Aldara-treated subjects developed treatment site infections that required a rest period and treatment with antibiotics.

Clinical Trials Experience: External Genital Warts

In controlled clinical trials for genital warts, the most frequently reported adverse reactions were local skin and application site reactions.

Some subjects also reported systemic reactions. Overall, 1.2% (4/327) of the subjects discontinued due to local skin/application site reactions. The incidence and severity of local skin reactions during controlled clinical trials are shown below.

local skin reactions in the treatment area as assessed by the investigator (external genital warts): erythema; erosion; excoriation / flaking; edema; scabbing; induration; ulceration; vesicles.

Remote site skin reactions were also reported. The severe remote site skin reactions reported for females were erythema (3%), ulceration (2%), and edema (1%); and for males, erosion (2%), and erythema, edema, induration, and excoriation / flaking (each 1%). Selected adverse reactions judged to be probably or possibly related to Aldara (Imiquimod) topical cream are listed below.

selected treatment related reactions (external genital warts): itching; burning; soreness; fungal infection; headache; influenza-like symptoms; myalgia.

Adverse reactions judged to be possibly or probably related to Aldara (Imiquimod) cream 5% and reported by more than 1% of subjects included:

Application Site Disorders: hypopigmentation, burning, irritation, pain, itching, rash, soreness, sensitivity, stinging, tenderness

Remote Site Reactions: burning, bleeding, itching, tenderness, pain, tinea cruris

Body as a Whole: fever, fatigue, influenza-like symptoms

Central and Peripheral Nervous System Disorders: headache

Gastro-Intestinal System Disorders: diarrhea

Musculo-Skeletal System Disorders: myalgia.

Clinical Trials Experience: Dermal Safety Studies

Provocative repeat insult patch test studies involving induction and challenge phases produced no evidence that Imiquimod (Aldara) cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Imiquimod (Aldara) topical cream to cause irritation, and application site reactions were reported in the clinical studies.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Imiquimod (Aldara) cream 5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Application Site Disorders: tingling at the application site.

Body as a Whole: angioedema.

Cardiovascular: cardiac failure, capillary leak syndrome, pulmonary edema, cardiomyopathy, arrhythmias (atrial fibrillation, tachycardia, palpitations), ischemia, chest pain, myocardial infarction, syncope.

Endocrine: thyroiditis.

Gastro-Intestinal System Disorders: abdominal pain.

Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma.

Hepatic: abnormal liver function.

Infections and Infestations: herpes simplex.

Musculo-Skeletal System Disorders: arthralgia.

Neuropsychiatric: cerebrovascular accident, agitation, convulsions (including febrile convulsions), insomnia, depression, multiple sclerosis aggravation, suicide, paresis.

Respiratory: dyspnea.

Urinary System Disorders: dysuria, proteinuria, urinary retention.

Skin and Appendages: erythema multiforme, exfoliative dermatitis, hyperpigmentation, hypertrophic scar.

Vascular: Henoch-Schonlein purpura syndrome.



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