Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

Plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Psoriatic arthritis
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.

Full Prescribing information

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Advisory information

contraindications
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Clinically important active infections (e.g. active tuberculosis, see section 4.4).

Usage information

Dosing and administration
Taltz is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Taltz is indicated.

Posology
Plaque psoriasis
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.

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.
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.
Use in special populations
Elderly (≥ 65 years)
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.

Paediatric population
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.
Pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.

Pregnancy
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.

Breast-feeding
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.

More information

Category Value
Agency product number EMEA/H/C/003943
Orphan designation No
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