Taltz Dosage/Direction for Use

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated.
Posology: Plaque psoriasis in adults: 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 (Q4W).
Paediatric plaque psoriasis (age 6 years and above): Efficacy and safety data is not available in children below the age of 6 years (see Pharmacology: Pharmacodynamics under Actions). Available data do not support a posology below a body weight of 25 kg.
The recommended dose given by subcutaneous injection in children is based on the following weight categories: see Table 13.

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Paediatric body weights must be recorded and regularly re-checked prior to dosing.
Psoriatic arthritis: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Axial spondyloarthritis (radiographic and non-radiographic): The recommended dose is 160 mg (two 80 mg injections) by subcutaneous injection at week 0, followed by 80 mg every 4 weeks (see Pharmacology: Pharmacodynamics under Actions for further information).
For all indications (plaque psoriasis in adults and children, psoriatic arthritis, axial spondyloarthritis) 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.
Special Populations: Elderly (≥ 65 years): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
There is limited information in subjects aged ≥ 75 years.
Renal or hepatic impairment: Ixekizumab (Taltz) has not been studied in these patient populations. No dose recommendations can be made.
Pediatric population: Paediatric plaque psoriasis (below the age of 6 years): There is no relevant use of Ixekizumab (Taltz) in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Paediatric psoriatic arthritis: The safety and efficacy of Ixekizumab (Taltz) in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established. No data are available. There is no relevant use of Ixekizumab (Taltz) in children below 2 years for the indication of psoriatic arthritis.
Method of administration: Subcutaneous use.
Ixekizumab (Taltz) is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Ixekizumab (Taltz) if a healthcare professional determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Comprehensive instructions for administration are given in the package leaflet and the user manual.