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Zyclara is a brand name for Imiquimod. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Zyclara (per application: up to 2 sachets, 250 mg imiquimod cream per sachet) should be applied once daily before bedtime to the skin of the affected treatment field (area) for two treatment cycles of 2 weeks each separated by a 2-week no-treatment cycle or as directed by the physician.
The treatment area is the full face or balding scalp. 4). 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 actinic keratosis counts may be observed during treatment due to the likely effect of imiquimod to reveal and treat subclinical lesions. Response to treatment cannot be adequately assessed until resolution of local skin reactions.
Patients should continue treatment as prescribed. Treatment should be continued for the full treatment course even if all actinic keratosis appear to be gone. 3 The clinical outcome of therapy has to be determined after regeneration of the treated skin, approximately 8 weeks after the end of treatment and on appropriate intervals thereafter based on clinical judgment.
Lesions that do not respond completely to treatment at 8 weeks after the second treatment cycle should be carefully re-evaluated and one additional 2-week treatment of Zyclara may be considered. A different therapy is recommended if the treated lesion(s) show(s) insufficient response to Zyclara.
Actinic keratosis lesions that have cleared after two Zyclara treatment cycles of 2 weeks and subsequently recur can be re-treated with one or two further Zyclara treatment cycles of 2 weeks following an at least 12 weeks treatment pause.
Hepatic or renal impairment Patients with hepatic or renal impairment were not included in clinical trials. These patients should be monitored under the close supervision of an experienced physician. Paediatric population The safety and efficacy of imiquimod in actinic keratosis in children and adolescents below the age of 18 years have not been established.
No data are available. Method of administration Zyclara is for external use only. Contact with eyes, lips, and nostrils should be avoided. The treatment area should not be bandaged or otherwise occluded. The prescriber should demonstrate the proper application technique to the patient to maximise the benefit of Zyclara therapy.
Summary of the safety profile:
The data described below reflect exposure to Zyclara or vehicle in 319 subjects enrolled in two double-blind studies. 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 6 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 known Skin infection Blood and lymphatic system disorders Common Lymphadenopathy Frequency not known Haemoglobin decreased 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 Blood glucose increased Psychiatric disorders Common Insomnia Uncommon Depression Irritability Nervous system disorders Common Headache Dizziness Eye disorders Uncommon Conjunctival irritation Eyelid oedema Respiratory, thoracic and mediastinal disorders Uncommon Nasal congestion Pharyngo laryngeal pain Hepatobiliary disorders Frequency not known Hepatic enzyme increased Gastrointestinal disorders Common Nausea Diarrhoea Vomiting Uncommon Dry mouth Abdominal pain Skin and subcutaneous tissue disorders Very common Erythema Scab Skin exfoliation Skin oedema Skin ulcer Skin hypopigmentation Common Dermatitis Uncommon Face oedema Rare Remote site dermatologic reaction Frequency not known Alopecia Erythema multiforme Stevens Johnson syndrome Cutaneous lupus erythematosus 7 Skin hyperpigmentation Musculoskeletal and connective tissue disorders Common Myalgia Arthralgia Uncommon Back pain Pain in extremity General disorders and administration site conditions Very common Application site erythema Application site scabbing Application site exfoliation Application site dryness Application site oedema Application site ulcer Application site discharge Common Application site reaction Application site pruritus Application site pain Application site swelling Application site burning Application site irritation Application site rash Fatigue Pyrexia Influenza-like illness Pain Chest pain Uncommon Application site dermatitis Application site bleeding Application site papules Application site paraesthesia Application site hyperaesthesia Application site inflammation Application site scar Application site skin breakdown Application site vesicles Application site warmth Asthenia Chills Lethargy Discomfort Inflammation Description of selected adverse reactions Blood system disorders Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials investigating the use of imiquimod 5% cream.
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.
4 Imiquimod cream therapy is not recommended until the skin has healed after any previous medicinal products or surgical treatment. 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.
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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Imiquimod in European Union.
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Zyclara should be applied once daily before bedtime to the skin of the affected treatment field (area) and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly.
Zyclara should be applied as a thin film to the entire treatment area and rubbed in until the cream vanishes. Up to 2 sachets of Zyclara may be applied to the treatment area (full face or scalp, but not both) at each daily application.
Partially-used sachets should be discarded and not reused. Zyclara should be left on the skin for approximately 8 hours; after this time it is essential that the cream is removed by washing the area and the hands with mild soap and water.
Hands should be washed carefully before and after application of cream. Missed dose In case a dose is missed, patients should wait until the forthcoming night to apply Zyclara and then continue with the regular schedule. The cream should not be applied more than once daily.
Each treatment cycle should not be extended beyond 2 weeks due to missed doses or rest periods.
These reductions are not considered to be clinically significant in patients with normal haematologic reserve. Patients with reduced haematologic reserve have not been studied in clinical trials. Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Skin infections Skin infections during treatment with imiquimod have been observed. While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered. 8 Hypopigmentation and hyperpigmentation Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Follow-up information suggests that these skin colour changes may be permanent in some patients. Remote site dermatologic reactions Rare cases of remote site dermatologic reactions, including erythema multiforme, have been reported from clinical trials with imiquimod 5% cream therapy.
4% (5/1214) frequency of alopecia at the treatment site or surrounding area. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
8). 8). Special populations Patients with cardiac, hepatic or renal impairment were not included in clinical trials. These patients should be monitored under the close supervision of an experienced physician. g. organ transplant patients) and/or patients with autoimmune conditions have not been established.
5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated either with the possibility of organ rejection or graft-versus-host disease or a possible worsening of their autoimmune condition.
1. g. contact dermatitis). Benzyl alcohol may cause allergic reactions and mild local irritation. Methyl parahydroxybenzoate (E 218), and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). 5