Zyclara · 4.1 Therapeutic indications · 1

HOS-096096 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile: The data described below reflect exposure to Zyclara or vehicle in 319 subjects enrolled in two double-blind studies. Subjects applied up to two sachets of Zyclara 3.75% cream or vehicle daily to the skin of the affected area (either entire face or balding scalp, but not both) for two 2-week treatment cycles separated by a 2-week no-treatment cycle. In clinical trials most patients (159/160) using Zyclara for the treatment of AK experience local skin reactions (most frequently erythema, scab, and exfoliation/application site dryness) at the application site. However, only 11% (17/160) of patients in clinical trials with Zyclara required rest periods (treatment interruption) due to local adverse reactions. Some systemic adverse reactions, including headache 6% (10/160), fatigue 4% (7/160), were reported by Zyclara treated patients in clinical trials. Tabulated list of adverse reactions Data presented in the table below reflects: - exposure to Zyclara or vehicle in above mentioned studies (frequencies very common to uncommon and at greater frequency after vehicle). - experience with imiquimod 5% cream 5 Frequencies are defined as: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (<1/10,000) and not known (cannot be estimated from the available data) System organ class Frequency Adverse reactions Infections and infestations Common Herpes simplex Uncommon Infection Pustules Frequency not Skin infection known Blood and lymphatic system Common Lymphadenopathy disorders Frequency not Haemoglobin decreased known White blood cell count decreased Neutrophil count decreased Platelet count decreased Immune system disorders Rare Exacerbation of autoimmune conditions Metabolism and nutrition disorders Common Anorexia

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HOS-096092 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-096091 · has-indication-information · PDF-Seite 2

Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.

HOS-096094 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. This includes studies with immunosuppressive medicinal products. Interactions with systemic medicinal products would be limited by the minimal percutaneous absorption of imiquimod cream. Due to its immunostimulating properties, imiquimod cream should be used with caution in patients who are receiving immunosuppressive medicinal products (see section 4.4). Concomitant use of Zyclara and any other imiquimod creams 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.

HOS-096095 · has-pregnancy-information · PDF-Seite 5

Pregnancy For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing Zyclara to pregnant women. Zyclara should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breast-feeding It is unknown whether imiquimod/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zyclara therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility No clinical data are available, potential risk for human is unknown.

HOS-096093 · has-warning-information · PDF-Seite 3

General instructions for treatment Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment. Contact with eyes, lips and nostrils should be avoided as imiquimod has not been evaluated for the treatment of actinic keratosis on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border. 3 Imiquimod cream therapy is not recommended until the skin has healed after any previous medicinal products or surgical treatment. Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (see section 4.8 and 4.9). Because of concern for heightened sunburn susceptibility, use of sunscreen is encouraged, and patients should minimise or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Zyclara. The skin surface area treated should be protected from solar exposure. Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns. Local skin reactions During therapy and until healed, affected skin is likely to appear noticeably different from normal skin. Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy. Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream. There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin reactions may be related to the stimulation of local immune response. Furthermore, imiquimod has the potential to exacerbate inflammatory conditions of the skin. If required by the patient’s discomfort or the intensity of the local skin reaction, a rest period of several days may be taken. Treatment with imiquimod cream can be resumed after the skin reaction has moderated. The intensity of the local skin reactions tend to be lower in the second cycle than in the first treatment cycle with Zyclara. Systemic reactions Flu-like systemic signs and symptoms may accompany, or even precede, intense local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, and chills. An interruption of dosing or dose adjustment should be considered (see section 4.8). Patient

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