TALTZ Solution for injection Ref.[8982] Active ingredients: Ixekizumab

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.

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.

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 syringe 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.

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.

Shelf life: 2 years.

Store in a refrigerator (2ºC–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. Pack sizes of 1, 2, or 3 pre-filled syringes. Not all pack sizes may be marketed.

Instructions for use

The instructions for using the syringe, included with the package leaflet, must be followed carefully.

The pre-filled syringe 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.