Stelara 45 mg Solution for Injection
*Company:
Janssen Sciences IrelandStatus:
UpdatedLegal 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 30 September 2024
File name
EN-IE-Stelara 45mg SFI 45mg SFI PFS 90mg SFI PFS-20240925-SmPC-PSUSA-3085-202312-clean-approved.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)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00003085/202312: PSUR (01 Jan 2023 to 31 Dec 2023): The EU PI was updated to advise against the use of live vaccines such as the BCG vaccine for a period of 12 months, instead of the previously stated 6 months.
Updated on 30 September 2024
File name
EN-IE-Stelara 45mg SFI-20240925-PIL-PSUSA-3085-202312-clean-approved.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00003085/202312: PSUR (01 Jan 2023 to 31 Dec 2023): The EU PI was updated to advise against the use of live vaccines such as the BCG vaccine for a period of 12 months, instead of the previously stated 6 months.
Updated on 24 September 2024
File name
EN-Stelara 45mg SFI 45mg SFI PFS and 90mg SFI PFS-20240905-SmPC-II-104-clean-approved.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000958/II/0104: Stelara I-CARE Final Report
Section 4.4 Special Warnings and Precautions for Use of the SmPC was updated to remove non-melanoma from the sentence “All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer.”
Updated on 24 July 2024
File name
EN-Stelara 45 SFI_45 PFS_90 PFS-20240613-SmPC-II-100-clean-approved.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000958/II/0100: Stelara OTIS Final Report
Updated on 24 July 2024
File name
EN-Stelara 45mg SFI-20240613-PIL-II-100-clean-approved.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000958/II/0100: Stelara OTIS Final Report
Updated on 21 June 2023
File name
Stelara 45mg vial & 90mg PFS SPC_21.06.2023.pdf
Reasons for updating
- 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
Section 5.1 was updated to include editorial reference to pre filled pen SPC.
Section 5.2 was updated to include the following: 'The bioavailability of ustekinumab following administration by syringe or pre-filled pen was comparable.'
Updated on 25 May 2023
File name
Stelara 45mg & 90mg 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 24 years of treatment in patients with ulcerative colitis.
Updated on 28 April 2023
File name
Stelara PIL 45mg vial_26.04.2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
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 45mg & 90mg 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 45 and 90 mg-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 22 December 2022
File name
Stelara PIL 45mg Vial-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 18 November 2022
File name
Stelara 45 and 90 mg-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
45mg Vial 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
Updated on 24 November 2021
File name
Stelara IENI 45 mg vial 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
Updated on 24 November 2021
File name
Stelara 45 and 90 mg-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 - how to report a side effect
- 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 45 mg vial 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 45 and 90 mg-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 45 mg vial 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 45 and 90 mg-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
Impact to section 5.1 of the SPC to include 5yr Chrons Disease and 2 year Ulcerative Colitis Dara
Updated on 19 March 2021
File name
Stelara IE 45 mg vial 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 45 and 90 mg-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 45 mg vial PIL CHMP 26Nov2020 - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 December 2020
File name
Stelara 45mg and 90mg-SmPC-7December2020-clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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 03 March 2020
File name
Stelara 45mg and 90mg SmPC CHMP16Jan2020 - clean.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 February 2020
File name
Stelara 45 vial PIL CHMP16Jan2020 - clean.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 27 January 2020
File name
Stelara 45mg 90mg vial and PFS SmPC-CD20Jan20-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to paediatric information
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1, 4.2, 4.8, 5.1, 5.2: addition of paediatric plaque psoriasis information for children from the age of 6.
Section 6.6: addition of recommendation on syringe size for single dose vial.
Updated on 27 January 2020
File name
Stelara 45mg Vial PIL-CD20Jan20-clean.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Paediatric plaque psoriasis information for children from the age of 6. Shortened contact address of local representatives.
Updated on 18 September 2019
File name
Stelara 45mg+90mg (vial _PFS)-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 - how to report a side effect
- 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 45mg 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 45mg+90mg (vial _PFS)-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
- 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 45mg 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 section 6 - 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 45mg 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 45mg + 90mg (vial_PFS)-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 16 January 2019
File name
Stelara 45mg + 90mg (vial_PFS)-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)
Updated on 23 October 2018
File name
Stelara 45mg 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 45mg vial PIL-26Jul18-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 22 August 2018
File name
Stelara 45mg + 90mg (vial_PFS)-SmPC-26Jul18-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
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 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
File name
PIL_14342_786.pdf
Reasons for updating
- New PIL for new product
Updated on 11 October 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 November 2016
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 November 2016
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 December 2015
Reasons for updating
- Product/presentation re-marketed
Updated on 03 September 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
- PIL product / presentation discontinued
Updated on 17 March 2010
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 23 July 2009
Reasons for updating
- New PIL for new product