Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.
Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).
Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
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.
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).
Efficacy and safety data is not available in children below the age of 6 years (see section 5.1). 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:
| Children’s body weight | Recommended starting dose (week 0) | Recommended dose every 4 weeks (Q4W) thereafter |
|---|---|---|
| Greater than 50 kg | 160 mg (two 80 mg injections) | 80 mg |
| 25 to 50 kg | 80 mg | 40 mg |
In case no 40 mg presentation is available, ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional using the commercial Taltz 80 mg pre-filled syringe.
Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg and do not require dose preparation.
Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re-checked prior to dosing.
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.
The recommended dose is 160 mg (two 80 mg injections) by subcutaneous injection at week 0, followed by 80 mg every 4 weeks (see section 5.1 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.
No dose adjustment is required in subjects aged ≥65 years (see section 5.2).
There is limited information in subjects aged ≥75 years.
Taltz has not been studied in these patient populations. No dose recommendations can be made.
Paediatric plaque psoriasis (below a body weight of 25 kg and below the age of 6 years):
There is no relevant use of Taltz in children below a body weight of 25 kg and below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Paediatric psoriatic arthritis:
The safety and efficacy of 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 Taltz in children below 2 years for the indication of psoriatic arthritis.
Subcutaneous use.
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 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.
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.
2 years.
Store in a refrigerator (2ºC to 8ºC).
Do not freeze.
Store in the original package in order to protect from light.
Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30ºC.
1 mL solution in a type I clear glass syringe.
The syringe is encased in a disposable, single-dose pen.
Packs of 1, 2, or 3 pre-filled pens.
Not all pack sizes may be marketed.
The instructions for using the pen, included with the package leaflet, must be followed carefully.
The pre-filled pen is for single use only.
Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown.
Taltz that has been frozen must not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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