TALTZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 80 MG/ML [SIN15501P]

Product Info

TALTZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 80 MG/ML

[SIN15501P]

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

Paediatric plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and adolescents 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 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Axial spondyloarthritis
Ankylosing spondylitis (radiographic axial spondyloarthritis)
Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

Non-radiographic axial spondyloarthritis
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).

4.2. Posology and method of administration
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 160mg by subcutaneous injection (two 80mg injections) at week 0, followed by 80mg (one injection) at weeks 2, 4, 6, 8, 10 and 12, then maintenance dosing of 80mg (one injection) every 4 weeks.

Paediatric plaque psoriasis (age 6 years and above)
Efficacy and safety data is not available in children below the age of 6 years (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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:

Paediatric body weights must be recorded and regularly re-checked prior to dosing.

Psoriatic arthritis
The recommended dose is 160mg by subcutaneous injection (two 80mg injections) at week 0, followed by 80mg (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 section 5.1 for further information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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
Paediatric plaque psoriasis (below the age of 6 years)
There is no relevant use of 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 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.

Method of administration
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 Instructions for Use.
For instructions on preparation of the medicinal product before administration, see section 6.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3. Contraindications
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Clinically important active infections (e.g. active tuberculosis, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).