Otulfi ®⯆

(ustekinumab)

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


Otulfi 130mg/26ml Solution for injection vial
Oltulfi 45mg solution for injection pre filled syringe
Otulfi 90mg solution for injection pre filled syring

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.

Otulfi Packshot 7 - 1

Details

Otulfi ® 130 mg in 26 mL (5 mg/mL) solution for infusion, 45 mg solution for injection in pre-filled syringe and 90 mg solution for injection in pre-filled syringe. Consult the Summary of Product Characteristics (SmPC) before prescribing.

Below are the indications for the 45mg and 90mg Prefilled Syring. 

Plaque psoriasis
Otulfi is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).

Paediatric plaque psoriasis
Otulfi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).

Psoriatic arthritis (PSA)
Otulfi, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

Crohn's Disease
Otulfi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

Below are the indications for the Otulfi ® 130 mg vial

Crohn's Disease

Otulfi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

Posology and method of administration
Otulfi 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. Otulfi concentrate for solution for infusion should only be used for the intravenous induction dose.

 

Item codeDescriptionPresentationPack Qty
F02110B11Otulfi 130mg/26ml solutionVial1
F02110A12Oltulfi 45mg solution for injectionPrefilled syringe1
F02110B12Otulfi 90mg solution for injectionPrefilled syringe1

Filename
Otulfi® Prescribing Information.pdf
Size
157 KB
Format
pdf
Otulfi ® Prescribing Information

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-OTU-2500018

Date of preparation: April 2025

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