Presentation and Status in Health Basket
1 X 1 ml X 80 mg/ml
Posology: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
Elderly (≥ 65 years): No dose adjustment is required. There is limited information in subjects aged ≥ 75 years.
Renal or hepatic impairment: Ixekizumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of Ixekizumab in children and adolescents aged 6 to 18 years have not yet been established. No data are available. There is no relevant use of Ixekizumab in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Serious hypersensitivity to the active substance or to any of the excipients. Clinically important active infections.
Infections: Treatment with Ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections. Ixekizumab should be used with caution in patients with clinically important chronic infection. If such an infection develops, monitor carefully and discontinue Ixekizumab if the patient is not responding to standard therapy or the infection becomes serious. Ixekizumab should not be resumed until the infection resolves. Ixekizumab must not be given to patients with active tuberculosis (TB). Consider anti-TB therapy prior to initiation of Ixekizumab in patients with latent TB.
Hypersensitivity: Serious hypersensitivity reactions, including some cases of angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration of Ixekizumab should be discontinued immediately and appropriate therapy initiated.
Inflammatory Bowel Disease: Cases of new or exacerbations of Crohn’s disease and ulcerative colitis have been reported. Caution should be exercised when prescribing Ixekizumab to patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, and patients should be monitored closely.
Immunisations: Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodium-free”.
Injection site reactions, upper respiratory tract infections (most frequently nasopharyngitis).
See prescribing information for full details.
Interaction with other medicinal products and other forms of interaction: The safety of Ixekizumab in combination with other immunomodulatory agents or phototherapy has not been evaluated. No formal in vivo drug-drug interaction studies have been conducted. A role for IL-17 in the regulation of CYP450 enzymes has not been reported. The formation of some CYP450 enzymes is, however, suppressed by increased levels of cytokines during chronic inflammation. Thus, anti-inflammatory treatments, such as with the IL-17A inhibitor ixekizumab, may result in normalisation of CYP450 levels with accompanying lower exposure of CYP450-metabolised co-medications. Therefore, a clinically relevant effect on CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin), cannot be excluded. On initiation of ixekizumab therapy in patients being treated with these types of medicinal products, therapeutic monitoring should be considered.
Pregnancy and Lactation
Pregnancy: There is a limited amount of data from the use of ixekizumab in pregnant women.
Lactation: It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion.
See prescribing information for full details.
Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity. Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have been reported without any serious adverse events. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Storage: Store in a refrigerator (2 ºC – 8 ºC). Do not freeze or shake. Store in the original package in order to protect from light.