Humira 40mg solution for injection in pre-filled pen
- Name:
Humira 40mg solution for injection in pre-filled pen
- Company:
AbbVie Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/20
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AbbVie Limited
Company Products
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Updated on 30 November 2020 SPC
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
Section 5.1
Sub-section Paediatric Uveitis, Efficay Results
The statement:
At Week 52, clinical remission per FMS in Week 8 responders, clinical response per FMS (defined as a decrease in Mayo Score ≥ 3 points and ≥ 30% from Baseline) in Week 8 responders, mucosal healing per FMS (defined as an Mayo endoscopy score ≤ 1) in Week 8 responders, clinical remission per FMS in Week 8 remitters, and the proportion of subjects in corticosteroid-free remission per FMS in Week 8 responders were assessed in patients who received Humira at the double-blind maximum 40 mg eow (0.6 mg/kg) and maximum 40 mg ew (0.6 mg/kg) maintenance doses (Table 32).
amended to:
At Week 52, clinical remission per FMS in Week 8 responders, clinical response per FMS (defined as a decrease in Mayo Score ≥ 3 points and ≥ 30% from Baseline) in Week 8 responders, mucosal healing (defined as Mayo endoscopy subscore ≤ 1) in Week 8 responders, clinical remission per FMS in Week 8 remitters, and the proportion of subjects in corticosteroid-free remission per FMS in Week 8 responders were assessed in patients who received Humira at the double-blind maximum 40 mg eow (0.6 mg/kg) and maximum 40 mg ew (0.6 mg/kg) maintenance doses (Table 32).
Updated on 26 November 2020 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
Updated on 26 November 2020 SPC
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 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 4.1
The following indication has ben added:
Paediatric ulcerative colitis
Humira is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Section 4.2
Dosing information updated to reflect Paediatric ulcerative colitis indication
Section 4.8
The following statement has been added under "Malignancies and lymphoproliferative disorders":
"No malignancies were observed in 93 paediatric patients with an exposure of 65.3 patient years during a Humira trial in paediatric patients with ulcerative colitis. "
The following statement has been added under "Hepato-biliary events":
"In the controlled Phase 3 trial of Humira in patients with paediatric ulcerative colitis (N=93) which evaluated efficacy and safety of a maintenance dose of 0.6 mg/kg (maximum of 40 mg) every other week (N=31) and a maintenance dose of 0.6 mg/kg (maximum of 40 mg) every Week (N=32), following body weight adjusted induction dosing of 2.4 mg/kg (maximum of 160 mg) at Week 0 and Week 1, and 1.2 mg/kg (maximum of 80 mg) at Week 2 (N=63), or an induction dose of 2.4 mg/kg (maximum of 160 mg) at Week 0, placebo at Week 1, and 1.2 mg/kg (maximum of 80 mg) at Week 2 (N=30), ALT elevations ≥ 3 X ULN occurred in 1.1% (1/93) of patients."
Section 5.1
The following statement has been added:
"In patients with moderately to severely active paediatric ulcerative colitis, the rate of anti-adalimumab antibody development in patients receiving adalimumab was 3%."
Information on safety and efficay from multicenter, randomized, double-blind clinical trial included.
Section 5.2
The following information has been added:
Following the subcutaneous administration of body weight-based dosing of 0.6 mg/kg (maximum of 40 mg) every other week to paediatric patients with ulcerative colitis, the mean trough steady-state serum adalimumab concentration was 5.01±3.28 µg/ml at Week 52. For patients who received 0.6 mg/kg (maximum of 40 mg) every week, the mean (±SD) trough steady-state serum adalimumab concentration was 15.7±5.60 μg/ml at Week 52.
Section 10.0
Date of revision: 11/2020
Updated on 20 August 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 August 2020 SPC
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 – Undesirable effects
- Addition of Kaposi’s sarcoma (frequency: not known) to Table 6
Section 10 – Date of Revision of the Text
- Amended to 08/2020
Updated on 22 November 2019 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.1 Therapeutic indications
Editorial change
Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
amended to:
Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
- Section 10. Date of Revision of Text
Amended to 11/2019
Updated on 22 November 2019 PIL
Reasons for updating
- Change to further information section
Free text change information supplied by the pharmaceutical company
Change to section 7 - injection Humira (steps 6, 7, 8)
Updated on 27 May 2019 SPC
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
The following updates have been made to section 5.1 of the SmPC:
- Additional text describing enrolment into long term extension study
Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks. Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira.
- Revision of study summary
- Revision of subject numbers
- Explanation that the number of enrolled subjects declined but data at later timepoints generally consistent with week 78
- Updated overall numbers for discontinuations based on full duration of study
Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment. Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2%) were in steroid-free quiescence. BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78. Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time. Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Date of Revision of text: updated to 05/2019
Updated on 11 March 2019 PIL
Reasons for updating
- Removal/change of distributor
Updated on 9 November 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 9 November 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
- Section 4.2 and section 4.4: “Patient Alert Card” changed to “Patient Reminder Card”.
Updated on 1 August 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 1 August 2018 SPC
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
Summary of Changes
Section 4.8
- Revised to include “lichenoid skin reaction” as a rare event under Skin and subcutaneous tissue disorders
Section 10
- Date of Revision of Text updated to 26 July 2018
Updated on 4 July 2018
Updated on 3 July 2018 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Update to section 4.6 - Fertility, pregnancy and lactation
Updated on 3 July 2018 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 5 June 2018 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 21 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 21 March 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 18 December 2017 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - use in children/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 20 November 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 14 September 2017 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 1 February 2017 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 21 December 2016 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
Updated on 7 November 2016 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 5 July 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 26 May 2016 PIL
Reasons for updating
- Introduction of new strength
Updated on 8 April 2016 PIL
Reasons for updating
- Changes to therapeutic indications
Updated on 15 December 2015 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 1 December 2015 PIL
Reasons for updating
- Change to dosage and administration
Updated on 5 August 2015 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 2 July 2015 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 5 June 2015 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 8 April 2015 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to instructions about overdose
- Change to storage instructions
- Change to dosage and administration
Updated on 25 March 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 5 September 2014 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to dosage and administration
Updated on 8 November 2013 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
Updated on 26 March 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
- Change to improve clarity and readability
Updated on 4 December 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to marketing authorisation holder
- Change to dosage and administration
- Changes to therapeutic indications
- Change to improve clarity and readability
Updated on 12 September 2012 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 27 February 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 1 July 2011 PIL
Reasons for updating
- Change to side-effects
- Change to dosage and administration
Updated on 18 February 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 8 October 2010 PIL
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
Updated on 21 June 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 1 June 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 10 August 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 1 May 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 13 March 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 10 October 2008 PIL
Reasons for updating
- Changes to therapeutic indications
- Change to information about driving or using machinery
Updated on 16 January 2008 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 24 July 2007 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 25 April 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 29 November 2006 PIL
Reasons for updating
- New PIL for new product