Humira 40mg solution for injection in pre-filled pen *

  • Company:

    AbbVie Limited
  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14 April 2021

File name

PL_Humira 40mg PEN_PRAC-weight gain_Apr2021_1618403536.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 14 April 2021

File name

SmPC_Humira 40mg PFS-PEN_PRAC-weight gain_Apr2021_1618403427.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)

Free text change information supplied by the pharmaceutical company

 

Section 4.8 – Undesirable effects

  • “Weight increased” is now listed in Table 7, under Investigations (Frequency: Not known). 

    The following corresponding information has been included in the footnotes:

    “The mean weight change from baseline for adalimumab ranged from 0.3 kg to 1.0 kg across adult indications compared to (minus) -0.4 kg to 0.4 kg for placebo over a treatment period of 4-6 months. Weight increase of 5-6 kg has also been observed in long-term extension studies with mean exposures of approximately 1-2 years without control group, particularly in patients with Crohn’s disease and Ulcerative colitis. The mechanism behind this effect is unclear but could be associated with the anti‑inflammatory effect of adalimumab.”

 

 

Section 10 – Date of Revision of the Text

  • Amended to “04/2021”

Updated on 30 November 2020

File name

SmPC_Humira 40mg PFS-40mgPFP_deletionwiesbaden_23Nov20_1606744629.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

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

File name

PL_Humira 40mg PEN_Paed UC_20Nov20_1606403911.pdf

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

File name

SmPC_Humira 40mg PFS-40mgPFP_Paed UC_20Nov20_1606403184.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 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

File name

PL_Humira40mgPFP_kaposi sarcoma_11Aug2020_1597916822.pdf

Reasons for updating

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

Updated on 20 August 2020

File name

SPC_Humira40mgPFS-PFP_Kaposi sarcoma_11Aug20_1597916760.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)

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

File name

SPC_Humira40mgPFS-PFP_V193_15Nov19_1574420592.pdf

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

File name

PIL_Humira40mgPFP_V193_15Nov19_1574420519.pdf

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

File name

SPC_Humira40mgPFS-PFP_V187_16May19_1558964536.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

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

File name

PL_Humira40mgPFP_V182_31Oct18_Brexit_1552316833.pdf

Reasons for updating

  • Removal/change of distributor

Updated on 09 November 2018

File name

PL_Humira40mgPFP_V182_31Oct18_1541766908.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 09 November 2018

File name

SPC_Humira40mgPFS-40mgPFP_V182_31Oct18_1541766974.pdf

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 01 August 2018

File name

PL_Humira40mgPFP_V179_26Jul18_1533133734.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 01 August 2018

File name

SPC_Humira40mgPFS-PFP_V179_26Jul18_1533133831.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)

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

 

File name

PL_Humira40mgPFP_V170_28Jun2018.pdf

Updated on 03 July 2018

File name

SPC_Humira40mgPFS-PFP_V170_28Jun2018.docx

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 03 July 2018

File name

PL_Humira40mgPFP_V170_28Jun2018.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 05 June 2018

File name

SPC_Humira40mgPFS-PFP_V175-V172_26Apr18.docx

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

File name

SPC_Humira40mgPFS-PFP_V175-V172_26Apr18.docx

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

File name

PL_Humira 40mg PFP_V175_23Apr18.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 21 March 2018

File name

PIL_11688_354.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 December 2017

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

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 14 September 2017

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 01 February 2017

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

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 07 November 2016

Reasons for updating

  • Improved presentation of PIL

Updated on 05 July 2016

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

Reasons for updating

  • Introduction of new strength

Updated on 08 April 2016

Reasons for updating

  • Changes to therapeutic indications

Updated on 15 December 2015

Reasons for updating

  • Correction of spelling/typing errors

Updated on 01 December 2015

Reasons for updating

  • Change to dosage and administration

Updated on 05 August 2015

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 02 July 2015

Reasons for updating

  • Change to improve clarity and readability

Updated on 05 June 2015

Reasons for updating

  • Change to improve clarity and readability

Updated on 08 April 2015

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

Reasons for updating

  • Change to side-effects

Updated on 05 September 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to dosage and administration

Updated on 08 November 2013

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

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 04 December 2012

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

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

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 01 July 2011

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration

Updated on 18 February 2011

Reasons for updating

  • Change to side-effects

Updated on 08 October 2010

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery

Updated on 21 June 2010

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 June 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 10 August 2009

Reasons for updating

  • Change to side-effects

Updated on 01 May 2009

Reasons for updating

  • Improved electronic presentation

Updated on 13 March 2009

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

Reasons for updating

  • Changes to therapeutic indications
  • Change to information about driving or using machinery

Updated on 16 January 2008

Reasons for updating

  • Change to, or new use for medicine

Updated on 24 July 2007

Reasons for updating

  • Change to, or new use for medicine

Updated on 25 April 2007

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 November 2006

Reasons for updating

  • New PIL for new product