Tyenne®▼

(tocilizumab)

For healthcare professionals only. This content contains promotional and brand information.
 
Scroll down for Tyenne prescribing information and further product details. 
For adverse event reporting see bottom of webpage.


Tyenne 162mg solution for injection in a pre-filled pen.
Tyenne 162mg solution for injection in a pre-filled syringe.
Tyenne 80mg concentrate for solution for infusion in a vial.
Tyenne 200mg concentrate for solution for infusion in a vial.
Tyenne 400mg concentrate for solution for infusion in a vial.

For the Republic of Ireland, the SmPC and Patient Leaflets are located on the Medicines.ie | Reliable & Accurate Online Medicines Information (medicines.ie)

Please note product images are for illustrative purposes only and labelling on actual products may appear differently.

Filename
Tyenne Prescribing Information.pdf
Size
2 MB
Format
pdf
Tyenne Prescribing Information.pdf

Details

Tyenne 162mg solution for injection in a pre-filled syringe and pre-filled pen are indicated for use in the following conditions. Please consult the SmPC before prescribing. Tyenne treatment should be initiated by healthcare professionals and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Tyenne is indicated.
  • Tyenne, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX*
  • Tyenne, in combination with methotrexate, is indicated for the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists*
*In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
  • Tyenne pre-filled syringe only: is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
  • Tyenne pre-filled pen only: is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 12 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
  • Tyenne pre-filled syringe only: in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
  • Tyenne pre-filled pen only: in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX.
  • Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Tyenne 20mg/ml concentrate for solution for injection is indicated for use in the following conditions. Please consult the SmPC before prescribing. Tyenne treatment should be initiated by healthcare professionals and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Tyenne is indicated.
  • Tyenne, in combination with methotrexate, is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.*
  • Tyenne, in combination with methotrexate, is indicated for the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease- modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.*
*In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
  • Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation
  • Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
  • Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
  • Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

Item CodeDescriptionPresentationCase Qty
F03102A11Tyenne 80mgVial 4ml1
F03102B11Tyenne 200mgVial 10ml1
F03102C11Tyenne 400mgVial 20ml1
F03102A42Tyenne 162mgPre filled syringe4
F03102A43Tyenne 162mgPre filled pen4

Adverse events should be reported.
Reporting forms and information can be found at:
www.hpra.ie/homepage/about-us/report-an-issue
Adverse events should also be reported to Fresenius Kabi Limited, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT Tel +44 (0)1928 533 533.

Job code: IE-TYE-2400017

Date of preparation: November 2024

This is intended for healthcare professionals in the Republic of Ireland only and contains information about Fresenius Kabi medicines. By accessing this information you are confirming you are a healthcare professional in the Republic of Ireland.

If you are a healthcare professional based in Northern Ireland please access the Fresenius Kabi UK site here for more information. www.fresenius-kabi.com/gb

If you are not a healthcare professional, please return to the Fresenius Kabi Ireland homepage where you can find more information for the public and for patients using Fresenius Kabi medicines or products.

IE-NP-2400056 November 2024