YESINTEK CONCENTRATE FOR SOLUTION FOR INFUSION 130MG/26ML [SIN17571P]

Product Info

YESINTEK CONCENTRATE FOR SOLUTION FOR INFUSION 130MG/26ML

[SIN17571P]

Indication

4.1 Therapeutic indications

Crohn’s Disease

Yesintek is indicated for the treatment of adults with moderately to severe active Crohn’s disease who have: failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or failed or were intolerant to treatment with one or more TNF blockers

Dosing

4.2 Posology and method of administration

Yesintek concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease.

Yesintek concentrate for solution for infusion should only be used for the intravenous induction dose.

Posology

Crohn’s Disease

Yesintek treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of Yesintek 130 mg as specified in Table 1 (see section 6.6 for preparation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the Yesintek solution for injection (vial) and solution for injection in pre-filled syringe SmPC.

Elderly

No dose adjustment is needed for patients aged 65 years and older (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal and hepatic impairment

Ustekinumab has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population

The safety and efficacy of ustekinumab for the treatment of Crohn’s disease in children less than 18 years have not yet been established. No data are available.

Method of administration

Yesintek 130 mg is for intravenous use only. It should be administered over at least one hour. For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

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 infection (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).