STELARA 130 mg concentrate for solution for infusion

  • Company:

    Janssen Sciences Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2023

File name

Stelara 130mg SPC_21.06.2023.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.2 and 5.1 have been updated to include editorial reference to pre-filled pen SPC.

Updated on 25 May 2023

File name

Stelara130mg SPC_25.05.2023.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 has been updated as follows:

Mechanism of action

.....

In patients with ulcerative colitis, treatment with ustekinumab resulted in a decrease in inflammatory markers including CRP and fecal calprotectin during the induction phase, which was maintained throughout the maintenance phase and study extension through week 92200.

….

Clinical efficacy

Crohn’s Disease

….

In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment in a study extension. Among the 718567 patients who entered on and were treated with ustekinumab in the study extension, clinical remission and response were generally maintained through week 252 for both patients who failed TNF-therapies and those who failed conventional therapies.

….

Study Extension

In UNIFI, patients who completed the study through week 44 were eligible to continue treatment in a study extension. Among the 588400 patients who entered on and were treated with ustekinumab every 12 or 8 weeks in the study extension, symptomatic remission was generally maintained through week 92200 for patients who failed conventional therapy (but not a biologic therapy) and those who failed biologic therapy, including those who failed both anti-TNF and vedolizumab. Among patients who received 4 years of ustekinumab treatment and were assessed using the full Mayo score at maintenance week 200, 74.2% (69/93) and 68.3% (41/60) maintained mucosal healing and clinical remission, respectively.

No new safety concerns were identified in this study extension with up to 2years of treatment in patients with ulcerative colitis.

 

 

Updated on 28 April 2023

File name

Stelara PIL 130mg vial_26.04.2023.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 has been updated as follows:

Before you use Stelara tell your doctor:

·               If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.

·               If you have ever had any type of cancer – this is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of cancer.

·               If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) – the risk of cancer may be higher.

 ….

 Heart attack and strokes

Heart attack and strokes have been observed in a study in patients with psoriasis treated with Stelara. Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.

Updated on 28 April 2023

File name

Stelara 130mg SPC_ 26.04.2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been updated as follows:

Infections

Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. In clinical studies and a post-marketing observational study in patients with psoriasis, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).

.....

Malignancies

Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some patients who received STELARA in clinical studies and in a post-marketing observational study in patients with psoriasis developed cutaneous and non‑cutaneous malignancies (see section 4.8). The risk of malignancy may be higher in psoriasis patients who have been treated with other biologics during the course of their disease.

.....

Cardiovascular events

Cardiovascular events including myocardial infarction and cerebrovascular accident have been observed in patients with psoriasis exposed to STELARA in a post-marketing observational study. Risk factors for cardiovascular disease should be regularly assessed during treatment with STELARA.

Updated on 22 December 2022

File name

Stelara PIL 130mg-PRI 7Dec2022.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 22 December 2022

File name

Stelara 130mg-SmPC-ec dec 7Dec2022 clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 November 2022

File name

Stelara 130mg-SmPC-ec dec 9Nov2022 clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 November 2022

File name

130mg PIL - Lupus PRAC - clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Lupus PRAC update - update to sections 2 and 4

Updated on 03 March 2022

File name

Stelara IENI 130mg PIL - CHMP Sep2021 clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 24 November 2021

File name

Stelara IENI 130mg PIL - CHMP Sep2021 clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 November 2021

File name

Stelara 130mg-SmPC-CHMP 16Sep21 clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 April 2021

File name

Stelara IE 130mg PIL Article 61(3) Add NI - CHMP 14042021 Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2021

File name

Stelara 130mg-SmPC-CHMP 9Mar21-CLEAN.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Impact to section 5.1 of the SPC to include 5yr Chrons Disease and 2 year Ulcerative Colitis Data

Updated on 22 March 2021

File name

Stelara IE 130mg PIL CHMP 9Mar21 - Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Free text change information supplied by the pharmaceutical company

Removal of : in section of 2 of the PIL

Updated on 19 March 2021

File name

Stelara 130mg-SmPC-CHMP 5Mar21-CLEAN.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include 5yr Chrons Disease and 2 year Ulcerative Colitis Dara

Updated on 19 March 2021

File name

Stelara IE 130mg PIL CHMP 5Mar21 - Clean.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Removal of : in section of 2 of the PIL

Updated on 13 January 2021

File name

Stelara 130mg-SmPC-CHMP 26Nov2020-clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 January 2021

File name

Stelara IE 130mg PIL CHMP 26Nov2020 - Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 February 2020

File name

Stelara 130mg PIL CHMP16Jan2020 - clean.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 27 February 2020

File name

Stelara 130mg SmPC CHMP16Jan2020 - clean.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 January 2020

File name

Stelara 130mg vial PIL-CD 20Jan20-clean.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 27 January 2020

File name

Stelara 130mg vial SmPC-CD20Jan20-clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: addition of paediatric plaque psoriasis related information for children from the age of 6.

Updated on 18 September 2019

File name

Stelara 130mg vial SmPC-CD16Sep19-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 September 2019

File name

Stelara 130mg vial PIL-CD16Sep19-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 September 2019

File name

Stelara 130mg vial SmPC-CD3Sep19-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of new therapeutic indications for the treatment of adult patients with moderately to severely active ulcerative colitis

Updated on 05 September 2019

File name

Stelara 130mg vial PIL-CD03Sep19-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

Addition of new therapeutic indications for the treatment of adult patients with moderately to severely active ulcerative colitis

Updated on 16 January 2019

File name

Stelara 130mg vial PIL-12Oct18-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 January 2019

File name

Stelara 130mg vial SmPC-29Nov18-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 addition of paragraph on respiratory reactions (allergic alveolitis and eosinophilic pneumonia).

Section 4.8 addition of ADRs allergic alveolitis and eosinophilic pneumonia under frequency rare.

Updated on 23 October 2018

File name

Stelara 130mg vial PIL-12Oct18-clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 22 August 2018

File name

Stelara 130mg vial PIL-26Jul18-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 22 August 2018

File name

Stelara 130mg vial SmPC-26Jul18-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: addition of information on sodium content

Section 4.8: deletion of immunogenicity paragraph

Section 5.1: addition of revised immunogenicity paragraph

Updated on 22 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 March 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: addition of traceability statement for biological medicinal products

Section 4.8: addition of statement “no new safety concerns were identified with up to 2 years of treatment in patients with Crohn’s Disease”; reporting of suspected adverse reactions – addition of Google Play and Apple App Store for MHRA Yellow Card

Section 5.1: addition of IM-UNITI study extension data

Section 6.3: Shelf life extension for pre-filled syringe presentations to 3 years

Updated on 21 March 2018

File name

PIL_16991_411.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 18 December 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.3 and 6.6: extension of in-use stability from 4 to 8 hours

Updated on 14 December 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 17 October 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: addition of ADR lower respiratory tract infection under frequency “uncommon”

Updated on 11 October 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects

Updated on 05 April 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3     Shelf life

 

                  2 3 years

Updated on 15 November 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 15 November 2016

Reasons for updating

  • New PIL for new product