Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 01 June 2018
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
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.
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.
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 (see section 5.2).
There is limited information in subjects aged ≥ 75 years.
Renal or hepatic impairment
Taltz has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years in the treatment of moderate to severe plaque psoriasis have not yet been established. No data are available.
There is no relevant use of Taltz in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
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.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.
There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy.
It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
|Agency product number||EMEA/H/C/003943|
|Date First Approved||25-04-2016|
|Type||Medicinal product subject to restricted medical prescription|
|Marketing authorisation holder||Eli Lilly Nederland B.V.|
|Warnings||This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions|