Humira 20 mg solution for injection in pre-filled syringe *

  • 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 20mg PFS_PRAC-weight gain_Apr2021_1618403912.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 20mg PFS_PRAC-weight gain_Apr2021_1618403810.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 26 November 2020

File name

SmPC_Humira 20mg PFS_Paed UC_20Nov20_1606403592.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

Repositioning of text

Section 5.2

Minor editorial changes

Section 10

Date of revision: 11/2020

Updated on 20 August 2020

File name

PL_Humira20mgPFS_kaposi sarcoma_11Aug20_1597917186.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_Humira20mgPFS_Kaposi sarcoma_11Aug20_1597917107.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_Humira20mgPFS_V193_15Nov19_1574420920.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 Pharmacodynamic properties
    Editorial change

Patients remained on stable doses of NSAIDs and or prednisone (£ 0.2 mg/kg/day or 10 mg/day maximum).


amended to: 


Patients remained on stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and or prednisone (£ 0.2 mg/kg/day or 10 mg/day maximum).
 

  • Section 10. Date of Revision of Text
    Amended to 11/2019

Updated on 17 September 2019

File name

PL_Humira20mgPFS_V186_01Mar19_1568728709.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Change to HPRA contact details

Updated on 27 May 2019

File name

SPC_Humira20mgPFS_V187_16May19_1558964807.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_Humira20mgPFS_V186_01Mar19_1552316693.pdf

Reasons for updating

  • Change to packaging

Updated on 09 November 2018

File name

PL_Humira20mgPFS_V182_31Oct18_1541767287.pdf

Reasons for updating

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

Updated on 09 November 2018

File name

SPC_Humira20mgPFS_V182_31Oct18_1541767356.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_Humira20mgPFS_V179_26Jul18_1533134245.pdf

Reasons for updating

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

Updated on 01 August 2018

File name

SPC_Humira20mgPFS_V179_26Jul18_1533134487.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

  • 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 06 July 2018

File name

PL_Humira20mgPFS_V170_28Jun2018.pdf

Reasons for updating

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

Updated on 03 July 2018

File name

SPC_Humira20mgPFS_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

Updat to section 4.6 - Fertility, pregnancy and lactation

Updated on 29 May 2018

File name

SPC_Humira20mgPFS_V175_23Apr18.docx

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

New presentation

Updated on 21 May 2018

File name

PL_Humira 20mg PFS_V175_23Apr18.pdf

Reasons for updating

  • New PIL for new product