Humira 40 mg solution for injection in pre-filled syringe

  • Name:

    Humira 40 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    adalimumab

  • 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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Summary of Product Characteristics last updated on medicines.ie: 26/11/2020

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AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Humira 20 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Humira 80 mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Kaletra 200 mg/50 mg film-coated tablets Active Ingredients Lopinavir, Ritonavir
Medicine Name Kaletra oral solution Active Ingredients Lopinavir, Ritonavir
Medicine Name Maviret 100 mg-40 mg film-coated tablets Active Ingredients Glecaprevir, Pibrentasvir
Medicine Name Norvir 100 mg powder for oral suspension Active Ingredients Ritonavir
Medicine Name Norvir 100mg Film-coated Tablets Active Ingredients Ritonavir
Medicine Name RINVOQ 15 mg prolonged-release tablets Active Ingredients Upadacitinib
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Skyrizi 75 mg solution for injection in pre-filled syringe Active Ingredients Risankizumab
Medicine Name Synagis Solution for Injection Active Ingredients Palivizumab
Medicine Name Venclyxto 10mg, 50mg and 100mg Film-coated Tablets Active Ingredients Venetoclax
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 21 items.Total: Infinity pages

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 26 November 2020

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

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 26 November 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

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

Reasons for updating

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

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

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

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 17 September 2019 PIL

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

Reasons for updating

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

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.

Updated on 11 March 2019 PIL

Reasons for updating

  • Change to packaging

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

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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
  • Change to section 6 - date of revision

Updated on 1 August 2018

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 4 July 2018

Updated on 3 July 2018

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

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 16 May 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Summary of changes
 

 

  • Section 4.2, Posology and method of administration
    • An 80mg every week (eow) dosing option has been included as an alternative to the current approved 40 mg weekly dose in the following relevant  indications:
      Rheumatoid arthritis
      Crohns disease

      Paedatric Crohns disease (patients  ≥ 40 kg)
      Psoraisis
      Ulcerative colitis
      Hidradenitis suppurativa
      Adolescent hidradenitis suppurativa

       
  • Section 5.1, Pharmacodynamic properties
    • The following information added in relation to non-radiographic axial spondyloarthritis (nr-axSpA):

      The safety and efficacy of Humira were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Study nr-axSpA I evaluated patients with active nr-axSpA. Study nr-axSpA II was a treatment withdrawal study in nr-axSpA patients who achieved remission during open-label treatment with Humira.

      SmPC now lists data in relation to  Study nr-axSpA II


       

 

  • Section 5.2, Pharmacokinetic properties
    • The following text has been added in relation to 80mg every other week :

      Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).

       
    • The following information has been added in relation to non-radiographic axial spondyloarthritis patients:

      Following subcutaneous administration of 40 mg of adalimumab every other week in adult non-radiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 mg/ml.


       

 

  • Section 10, Date of Revision of the Text
    • Updated to 23 April 2018
  • Minor editoral and formatting changes made through out document

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 22 March 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 22 March 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7: Marketing Authorisation holder:

 - Change from from AbbVie Ltd to AbbVie Deutschland GmbH & Co. KG

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 12 February 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 22 December 2017 SPC

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • 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 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 2 -  Qualitative and Quantitative Composition

The following sentence amended as follow:

Adalimumab is a recombinant human monoclonal antibody expressed produced in Chinese Hamster Ovary cells.

 

Section 3 – Pharmaceutical Form
The following statement amended as follow:

·         Solution for injection. (injection)

 

Section 4.2 – Posology and method of administration

·         Polyarticular juvenile idiopathic arthritis and Enthesitis-related arthritis  - CHANGE TO DOSING

The requirement for body surface area dosing has been replaced by a fixed dosing scheme based on body weight.


The following is the revised dosing information:

Polyarticular juvenile idiopathic arthritis from 2 years of age
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). Humira is administered every other week via subcutaneous injection.  Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Table 1. Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthrtis

 

Patient Weight

Dosing Regimen

10 kg to < 30 kg

20 mg every other week

≥ 30 kg

40 mg every other week

 

Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

 

Enthesitis-related arthritis

The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).  Humira is administered every other week via subcutaneous injection.  Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

 

Table 2. Humira Dose for Patients with Enthesitis-Related Arthritis

 

Patient Weight

Dosing Regimen

15 kg to < 30 kg

20 mg every other week

≥ 30 kg

40 mg every other week

 

 

·         Paediatric plaque psoriasis posology - CHANGE TO DOSING


The requirement for body weight dosing has been replaced by a fixed dosing scheme based on body weight.

 

The following is the revised dosing information:

Paediatric plaque psoriasis

The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). Humira is administered via subcutaneous injection Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

 

Table 3. Humira Dose for Paediatric Patients with Plaque Psoriasis

 

Patient Weight

Dosing Regimen

15 kg to < 30 kg

Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose

≥ 30 kg

Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose

 

·         Paediaric Crohn’s disease and Paediatric Uveitis:

Dosing information has been put in a table

 

·         The following statement has been added to the posology for each  of the paediatric indication:

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.


Section 4.4 – Special warnings and precautions for use

·         Minor editorial changes

Section 4.8 – Undesirable effects

·         Minor editorial changes

·         The following statement (Hepato-biliary events subsection) has been updated as follows:

In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.

Section 5.1 - Pharmacodynamic properties

·         The following information has been added to the Immunogenicity sub-section:

In patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years old or aged 4 and above weighing <15 kg, anti-adalimumab antibodies were identified in 7% (1/15) of patients, and the one patient was receiving concomitant methotrexate.

·         The following statement has been updated as follows:

In adult patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.

 

 

 

Section 5.2      Pharmacokinetic properties

·      The below statement has been updated:

In adult patients with uveitis, a loading dose of 80 mg adalimumab on Week 0 followed by 40 mg adalimumab every other week starting at Week 1, resulted in mean steady-state concentrations of approximately 8 to 10 mg/mL.

·         The following text has been added:

Exposure-response relationship in paediatric population


On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response. The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1‑6 μg/ml).

Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively. PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively). 

 

 

Section 6.6  - Special precautions for disposal

·         Updated as follows:


The following has been removed:

Humira does not contain preservatives

 

Section 10 – Date of Revision of the Text:

·         Update to 08 December 2017

 

Updated on 18 December 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 - 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 24 October 2017 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

Section 5.1

Subsection – Adult Uveitis

 

The following information has been added:

 

Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment. Based on the observed data approach, 222 (80.4%) 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 184 (66.7 %) were in steroid-free quiescence. BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78. Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.

Updated on 15 September 2017 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

Summary of Changes

 

Section 4.1      Therapeutic indications

The following indication has been added:

 

Paediatric Uveitis

 

Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

 

Section 4.2 Posology and method of administration 

 

The following information has been added:

Paediatric Uveitis

In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.

 

Paediatric uveitis patients < 30 kg:

The recommended dose of Humira is 20 mg every other week in combination with methotrexate.

When Humira therapy is initiated, a loading dose of 40 mg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of a Humira loading dose in children < 6 years of age (see section 5.2).

 

Paediatric uveitis patients ≥ 30 kg:

The recommended dose of Humira is 40 mg every other week in combination with methotrexate.

When Humira therapy is initiated, a loading dose of 80 mg may be administered one week prior to the start of maintenance therapy.

There is no relevant use of Humira in children aged less than 2 years in this indication.

 

It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).

 

The following text has been removed:

Paediatric uveitis

The safety and efficacy of Humira in children aged 2‑17 years have not yet been established. No data are available.

 

Section 4.8      Undesirable effects

 

The below paragraph has been amended as follows:

 

Malignancies and lymphoproliferative disorders

No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during Humira trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis). In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during Humira trials in paediatric patients with Crohn’s disease. No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a Humira trial in paediatric patients with chronic plaque psoriasis. No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during a Humira trial in paediatric patients with uveitis.

 

Section 5.1  Pharmacodynamic properties

 

 

The following  sub-paragraph has been added:

 

Paediatric Uveitis

The safety and efficacy of Humira was assessed in a randomized, double‑masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.  Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.

 

The primary endpoint was ‘time to treatment failure’. The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.

 

Clinical Response

 

Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 2, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.  Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI:  0.12, 0.49]).



Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study

The following sub-paragraph has been amended as follows:

The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis and non-infectious uveitis, see section 4.2 for information on paediatric use.

 

Section 5.2      Pharmacokinetic properties

 

The following information has been added:

 

Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn’s disease, and enthesitis-related arthritis). No clinical exposure data are available on the use of a loading dose in children < 6 years. The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.

 

Section 10 Date of Revision of the Text

 

Amended to 05 September 2017

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 22 July 2017 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:

Hidradenitis suppurativa

 

The paragraph:

Patients participating in Studies HS-I and HS-II were eligible to enroll into an open‑label extension study in which Humira 40mg was administered every week.   Throughout all 3 studies patients used topical antiseptic wash daily.

 

 

Has been amended to:

Patients participating in Studies HS-I and HS-II were eligible to enroll into an open‑label extension study in which Humira 40mg was administered every week. Mean exposure in all adalimumab population was 762 days.   Throughout all 3 studies patients used topical antiseptic wash daily.

 

Clinical Response

The paragraph:

Among patients who were at least partial responders at Week 12, and who received continuous weekly Humira therapy, the HiSCR rate at Week 48 was 64.3%.

 

Has been amended to:

 

Among patients who were at least partial responders at Week 12, and who received continuous weekly Humira therapy, the HiSCR rate at Week 48 was 68.3% and at Week 96 was 65.1%. Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings.

 

 

Updated on 25 April 2017 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



Section 5.1 (Pharmacodynamic  properties)

Ø  Sub-section  Enthesitis-related arthritis

The statement:

Improvement in number of active joints with arthritis was maintained during the OL period through Week 52 of the study.

Has been amended to

Improvement in number of active joints with arthritis was maintained during the OL period through Week 156 for the 26 of 31 (84%) patients in the Humira group who remained in the study.

Section 10 (Date of Revision of Text)

Ø  Updated to 19-Apr-17

 

Updated on 3 February 2017 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

Section 5.1 -Pharmacodynamic properties

 

The following information has been added:

 

Psoriasis Study IV compared efficacy and safety of Humira versus placebo in 217 adult patients with moderate to severe nail psoriasis. Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label Humira treatment for an additional 26 weeks. Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician’s Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 13). Humira demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).

 

Table 13

Ps Study IV Efficacy Results at 16, 26 and 52 Weeks

Endpoint

Week 16

Placebo-Controlled

Week 26

Placebo-Controlled

Week 52

Open-label

Placebo
N=108

Humira

40 mg eow
N=109

Placebo
N=108

Humira

40 mg eow
N=109

Humira

40 mg eow
N=80

≥ mNAPSI 75 (%)

2.9

26.0a

3.4

46.6a

65.0

PGA-F clear/minimal and ≥2-grade improvement (%)

2.9

29.7a

6.9

48.9a

61.3

Percent Change in Total Fingernail NAPSI (%)

-7.8

-44.2 a

-11.5

-56.2a

-72.2

a p<0.001, Humira vs. placebo

 

Humira treated patients showed statistically significant improvements at Week 26 compared with placebo in the DLQI.

 

 

Section 10.  Date of Revision of Text

Amended to 26 January 2017

 

 

Note:

Minor editorial changes have been made throughout the document

 

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 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 (Therapeutic indications)

Updated to include Adolescent hidradenitis suppurativa (HS)

Hidradenitis suppurativa (HS)

Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).”

 

Section 4.2   (Posology and method of administration) 

 

Updated to reflect approval of adolescent HS indication:

Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)

There are no clinical trials with Humira in adolescent patients with HS.  The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).

The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.

 

In adolescent patients with inadequate response to Humira 40 mg every other week, an increase in dosing frequency to 40 mg every week may be considered.

Antibiotics may be continued during treatment with Humira if necessary.  It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira.

 

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. 

 

Should treatment be interrupted, Humira may be re-introduced as appropriate.

 

The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).

 

There is no relevant use of Humira in children aged less than 12 years in this indication.

The following section has been deleted:
Paediatric hidradenitis suppurativa

The safety and efficacy of Humira in children aged 12-17 years have not yet been established for hidradenitis suppurativa.   No data are available. There is no relevant use of Humira in children aged below 12 years for this indication.

 

Section 5.1          Pharmacodynamic properties

 

The following sections have been added:

Adolescent hidradenitis suppurativa

 

There are no clinical trials with Humira in adolescent patients with HS.  Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels. Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).

The following paragraph has been amended:


From:


“Paediatric population

 

The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis, hidradenitis suppurativa and non-infectious uveitis, see section 4.2 for information on paediatric use.”

 

To:

 

Paediatric population

 

The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis and non-infectious uveitis, see section 4.2 for information on paediatric use.

 

 

Section 5.2          Pharmacokinetic properties

 

Absorption and distribution sub-section:

The following paragraph has been amended

From:

In patients with hidradenitis suppurativa, a dose of 160 mg Humira on Week 0 followed by 80 mg on Week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at Week 2 and Week 4.  The mean steady-state trough concentration at Week 12 through Week 36 were approximately 8 to 10 μg/mL during adalimumab 40 mg every week treatment. 

To:

In adult patients with hidradenitis suppurativa, a dose of 160 mg Humira on Week 0 followed by 80 mg on Week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at Week 2 and Week 4.  The mean steady-state trough concentration at Week 12 through Week 36 were approximately 8 to 10 μg/mL during adalimumab 40 mg every week treatment. 

 

The following information has been added:

Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn’s disease, and enthesitis-related arthritis). The recommended adolescent HS dosing schedule is 40 mg every other week. Since exposure to adalimumab can be affected by body size, adolescents with higher body weight and inadequate response may benefit from receiving the recommended adult dose of 40 mg every week.

 

 

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 21 September 2016 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

Humira SmPC has been updated to reflect approval of V156 - addition of long term data from DE013 (PREMIER) to section 5.1 the SmPC.

The following is a summary of the changes to section 5.1 (Pharmacodynamic properties)

 

The following paragraph (within “Rheumatoid arthritis” has been amended as follows:

RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months). This study evaluated the efficacy of Humira 40 mg every other week/methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.

now reads:

RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months). This study evaluated the efficacy of Humira 40 mg every other week/methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks. Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of Humira was administered every other week up to 10 years.

 

 

The following information has been added underneath Table 3:

In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years. Of 542 patients who were randomised to Humira 40 mg every other week, 170 patients continued on Humira 40 mg every other week for 10 years. Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.

The 2nd paragraph beneath  
Table 3 (Humira Pen and Pre-filled Syringe SmPC) / Table 7 (Humira Vial SmPC)  
has been amended as follows:

At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy. Humira/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Humira monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis. The response for the two monotherapy arms was similar (p = 0.447).

now reads:

At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy. Humira/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Humira monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis. The response for the two monotherapy arms was similar (p = 0.447). Of 342 subjects originally randomized to Humira monotherapy or Humira/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of Humira treatment. Among those, 109 subjects (63.7%) were reported to be in remission at 10 years.

 

The following information has been added as a second paragraph beneath Table 5:


In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomized to methotrexate monotherapy, Humira monotherapy and Humira/methotrexate combination therapy, respectively. The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.

 

The 3rd paragraph, beneath “ Quality of Life and physical function” has been amended to read as follows:

In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at week 52, which was maintained through Week 104.

Now reads:

In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at week 52, which was maintained through Week 104. Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.

 

 

Updated on 6 July 2016 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

4.1    Therapeutic indications

 

·         The following indication has been added:

Uveitis
Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

 

4.2     Posology and method of administration 

 

·   The following statement has been added to the 1st paragraph:

Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4).


·   The following section, relating to administration in adult patients with uveitis has been added:

Uveitis
The recommended dose of Humira for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with Humira alone. Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.  
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1). 

Paediatric uveitis
The safety and efficacy of Humira in children aged 2‑17 years have not yet been established. No data are available.

 

 

4.4    Special warnings and precautions for use 

 

·         The following additional warning has been added relating to Neurological events:

Prescribers should exercise caution in considering the use of Humira in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Humira should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Humira therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.


·         Under the “Elderly” sub-heading:
The frequency of serious infections among Humira treated subjects over 65 years of age (from 3.6% to 3.7%)  and under 65 years (from 1.4% to 1.5%) has been amended


4.8 Undesirable effects

·   Paragraph 1: the number of patients studied (Humira and placebo trials) amended

·   The following statement added:

Uveitis
The safety profile for patients with uveitis treated with Humira every other week was consistent with the known safety profile of Humira.

·   Malignancies and lymphoproliferative disorders: 
Update to the number of patient years quoted.
Uveitis trials added


·   The following paragraph has been added:
In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.

 

 

Section 5.1 Pharmacodynamic properties

 

·    The following paragraph has been added:

Uveitis
The safety and efficacy of Humira were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II). Patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. Concomitant stable doses of one non-biologic immunosuppressant were permitted.

Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15.

Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease. Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19.
The primary efficacy endpoint in both studies was ´time to treatment failure´. Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).

Clinical Response

Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 22). Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 1).

 

Table 22

Time to Treatment Failure in Studies UV I and UV II

 

Analysis

         Treatment

N

Failure
N (%)

Median Time to Failure (months)

HRa

CI 95% for HRa

P Value b

Time to Treatment Failure At or After Week 6 in Study UV I 

Primary analysis (ITT)

 

 

 

 

 

         Placebo

107

84 (78.5)

3.0

--

--

--

         Adalimumab

110

60 (54.5)

5.6

0.50

0.36, 0.70

< 0.001

Time to Treatment Failure At or After Week 2 in Study UV II

Primary analysis (ITT)

 

 

 

 

 

         Placebo

111

61 (55.0)

8.3

--

--

--

         Adalimumab

115

45 (39.1)

NEc

0.57

0.39, 0.84

0.004

Note:  Treatment failure at or after Week 6 (Study UV I), or at or after Week 2 (Study UV II), was counted as event. Drop outs due to reasons other than treatment failure were censored at the time of dropping out.

a           HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.

b          2-sided P value from log rank test.

c           NE = not estimable. Fewer than half of at-risk subjects had an event.

 

Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)



In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.  In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.

 

Quality of Life

 

Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25. Humira was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II. Vision related effects were not numerically in favour of Humira for colour vision in Study UVI and for colour vision, peripheral vision and near vision in Study UV II.

·         The following has been added under the sub heading, Immunogenicity:

In patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.

5.2       Pharmacokinetic properties

·         The following has been added:

In patients with uveitis, a loading dose of 80 mg adalimumab on Week 0 followed by 40 mg adalimumab every other week starting at Week 1, resulted in mean steady-state concentrations of approximately 8 to 10 mg/mL.

 





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 20 May 2016 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 - how to report a side effect
  • 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

The indication for paediatric Crohn's disease has been extended to paediatric patients with moderate active Crohns disease.

Section 4.1
Paediatric Crohn's disease indication now reads:


"Paediatric Crohn's disease

 Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies."


Section 4.2
Posology and method of administration for Paediatric Crohn's disease now reads:

 

"Paediatric Crohn's disease

Paediatric Crohn's disease patients < 40 kg:    

 

The recommended Humira induction dose regimen for paediatric subjects with moderately to severely active Crohn's disease is 40 mg at Week 0 followed by 20 mg at Week 2.  In case there is a need for a more rapid response to therapy, the regimen 80 mg at Week 0 (dose can be administered as two injections in one day), 40 mg at Week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.

 

After induction treatment, the recommended dose is 20 mg every other week via subcutaneous injection.  Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 20 mg Humira every week. 

 

Paediatric Crohn's disease patients ≥ 40 kg:  

 

The recommended Humira induction dose regimen for paediatric subjects with moderately to severely active Crohn's disease is 80 mg at Week 0 followed by 40 mg at Week 2.  In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at Week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.

 

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.  Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 40 mg Humira every week. 

 

Continued therapy should be carefully considered in a subject not responding by Week 12.

 

There is no relevant use of Humira in children aged less than 6 years for this indication."


Section 4.8:


Subsection, Malignancies and lymphoproliferative disorders
- The number of patient years for paediatric patients with Crohns Disease  (during Humira trials) has changed to 498.1 patient years (previously 258.9 patient years).



Section 5.1:
The following has been added under the sub-section Paediatric Crohn's disease:

"One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.  After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in clinical response per PCDAI."


The following has been added under the subsection Immunogenicity:

"In patients with moderately to severely active paediatric Crohn’s disease, the rate of anti-adalimumab antibody development in patients receiving adalimumab was 3.3%."





Updated on 6 May 2016 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 2  QUALITATIVE AND QUANTITATIVE COMPOSITION

  • Injection volume has changed from 0.8ml to 0.4 ml

 

Section 4.2  Posology and method of administration 

Dosing tables  have been removed from the following  indications listed under Paediatric Population section:

Juvenile idiopathic arthritis & Enthesitis-related arthritis 
Paediatric plaque psoriasis.  

A statement has been added that for paediatric dosing information, see Summary of Product Characteristics for Humira 40 mg/0.8 ml solution for injection for paediatric use.

Section 6.1 List of excipients

List of excipients has changed - the following excipients have been removed:
Sodium citrate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Sodium chloride
Sodium hydroxide

Section 6.5    Nature and contents of container 
Updated to reflect new Pen & Syringe fill volume (0.4ml)

Section 8 Marketing Authorisation Numbers:
Updated to reflect new MA numbers:

EU/1/03/256/012

EU/1/03/256/013

EU/1/03/256/014

EU/1/03/256/015

EU/1/03/256/016

EU/1/03/256/017

EU/1/03/256/018

EU/1/03/256/019




Updated on 11 April 2016 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

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Section 4.1

  • The indication for Psorias has been changed from:

"Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA."

to

"Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy."

Section 4.2

  • The following statement has been added under the sub-section,  Rheumatoid Arthritis:

    "Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.  Continued therapy should be reconsidered in a patient not responding within this time period."
  • Within the Sub-section, Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis the following statement has been amended:

    From:

    For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.  Continued therapy should be carefully reconsidered in a patient not responding within this time period.

    to:

    Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.  Continued therapy should be reconsidered in a patient not responding within this time period.

Section 5.1

  • Hidradenitis suppurativa sub-section:  Under Clinical Response, the following statement has been amended:

Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline). 






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 2 December 2015 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
  • 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)

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Section 4.2

- the heading "Impaired renal and/or hepatic function"  has been changed to "Renal and/or hepatic impairment".


- the following has been added underneath "Psoriasis":

Beyond 16 weeks, patients with inadequate response may benefit from an increase in dosing frequency to 40 mg every week.  The benefits and risks of continued weekly Humira therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see section 5.1).  If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week.




Section 4.4
the heading "Elderly patients" has been changed to "Elderly".


Section 5.1
- Under "Paediatric plaque psoriasis, the meaning of the acronyms "PGA" and "PASi" have been included - Physician’s Global Assessment  & Psoriasis Area and Severity Index
- Under Adult plaque psoriasis,  the sentence:

In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50% and were evaluated at 12 weeks after dose escalation, 93/349 (26.6%) of patients achieved PASI 75 response.



has been changed to:

In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, (26. 4%) (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at Week 12 and 24, respectively.

Updated on 1 December 2015 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 6 August 2015 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 7 - Marketing authorisation holder
  • 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

4.1 Therapeutic indications Addition of Hidradenitis suppurativa (HS) indication
4.2 Posology Addition of Hidradenitis suppurativa (HS) and dosing
4.8 Undesirable effects Safety profile data update following addition of HS
5 Pharmacological properties Addition of HS  data
7 Marketing Authorisation Holder Change in the Post code
10 Date of revision Updated with HS approval date

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 7 July 2015 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • 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 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 3
"Clear solution for injection" changed to "Solution for injection.  Clear, colourless solution"

Section 4.1 & 4.2
Minor formatting changes

Section 4.4
"Older people" changed to "Elderly people"

Section 4.6
The following text has been repositioned to the top of section 4.6.

"Women of child bearing potential/Contraception in males and females

Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment"

Section 4.8
"Summary of the safety profile" moved to the top of section 4.8.
Minor formatting changes made throughout section 4.8.

Section 5.1
Minor formatting changes

The following information has been added to sub-section, Axial spondyloarthritis without radiographic evidence of AS

-          Addition of statement on maintenance of efficacy up to 156 Weeks

-          Addition of ASDAS response data at week 12 (secondary endpoint from Study M10-791)

-          Addition of ASDAS-ID response data at week 12 (non-ranked secondary endpoint from Study M10-791)

-          Addition of data on reduction of inflammation (CRP and SPARCC MRI scores; secondary endpoints from Study M10-791) at week 12 as well as a statement regarding long term maintenance of efficacy as measured by CRP and MRI up to Weeks 156 and Week 104, respectively

-          Addition of statement regarding long term maintenance of improvements on quality of life and physical function


Section 6.3
24 months changed to 2 years

Section 6.6

"Humira 40mg solution for injection does not contain preservatives" changed to "Humira does not contain preservatives"

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 9 April 2015 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

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Section 4.1
Addition of the following indication:

Paediatric plaque psoriasis

Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

Section 4.2
Subsection included on method of administration in paediatric plaque psoriasis

Section 4.8
1st paragraph: number of patients involved in clinical controlled trials updated
2nd paragraph: proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies changed to 6.0% for patients taking Humira

The following subsections have been updated: Infections, Malignancies and lymphoproliferative disorders, Hepato-biliary events

Section 5.1
Pharmacotherapeutic group updated to Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors. ATC code: L04AB04

Section added relating to Paediatric plaque psoriasis

Section 5.2
The following text has been added:
Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).





Updated on 8 April 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to instructions about overdose
  • Change to dosage and administration
  • Change of special precautions for disposal

Updated on 25 March 2015 SPC

Reasons for updating

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

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Section 4.8
Addition of the ADR vasculitis (frequency uncommon), under Immune system disorders 

Updated on 25 March 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 12 September 2014 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

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Changes to sections 4.1, 4.2, 4.8, 5.1 and 5.2 reflect the indication extension for Humira as a treatment for paediatric subjects with Enthesitis-related arthritis, 6 years of age and older, who have had an inadequate response to, or are intolerant of, conventional therapy.

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 19 May 2014 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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In section 4.8 the call for reporting statement has been updated to reflect the current IMB wording.
In section 5.1 the addition of clinical data from a hand and foot psorasis study

Updated on 11 April 2014 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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* Section 4.4 (Special warnings and precautions for use), a statement added on the importance of recording the trade name and batch number for the traceability of biological medicinal products. Aligned with Directive 2010/84/EU.
* Section 5.1 (Pharmacodynamic properties) update to Ulcerative Colitis clinical data.

Updated on 18 November 2013 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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SmPC changes are related to (i) an update in the safety information in line with the latest CCDS and (ii) to update in line with the latest QRD template version 9.

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 29 March 2013 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 6.4 - Special precautions for storage

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Changes to the Humira Pre-filled Syringe and Pre-filled Pen SmPC result from the:
 (i) Extension of the paediatric indication for polyarticular Juvenile idiopathic Arthritis (JIA) from 4 to 17 years of age to 2 to 17 years of age.
(ii) Inclusion of an alternative Room Temperature storage (25C for a period of up to 14 days) and protect from light statement.

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 7 December 2012 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

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SPC section 4.1, 4.2, 4.8, 5.1 and 5.2 updated following the addition of new Indication for Paediatric Crohn's Disease.
SPC section 5.1 updated with 10 year study data related to ACR response, Radiographic progress and Physical function.
SPC section 4.8 updated to add Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin) with a frequency of 'Not Known'

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 3 December 2012 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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In section 7 (Marketing Authorisation Holder) 
MA Holder transferred from Abbott Ltd to AbbVie Ltd following company separation.

Updated on 12 September 2012 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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Sections 4.1 (Therapeutic Indications), 4.2 (Posology and method of administration) and 5.1 (Pharmacodynamic properties) have updated following the extension of the Humira Crohn's indication to include patients with moderate disease.

Updated on 11 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 17 August 2012 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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In section 4.1 & 4.2: addition of new indication - Axial Spondyloarthritis without radiographic evidence of Ankylosing Spondylitis
Sections 4.4, 4.8 & 5.1 updated with new safety and clinical data

Updated on 8 May 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 18 April 2012 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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Updates to SPC for the new Humira indication in the treatment of Ulcerative Colitis in adults. In addition a safety change made to Section 4.4, 'Serious Infections' to add Legionellosis.

Updated on 20 February 2012 SPC

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

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* In section 4.4 update to the following sections on: 'Infections', 'Hepatitis B reactivation', 'Neurological events' and 'malignancies and lymphoproliferative disorders'.
* In section 4.6 update to the pregnancy and warning statement.
* In section 4.8 brought in line with SmPC guideline

Updated on 1 July 2011 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

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The changes to the SPC reflect the extension to the existing Juvenile Idiopathic Indication (JIA) to treat JIA patients aged 4 to 17 years, where the previous indication age range was 13 to 17 years of age. There will be additional dosing by Body Surface Area (BSA) to support flexible dosing for 4 to 12 years of age. A single dose vial is being introduced for this label extension.

Updated on 30 June 2011 PIL

Reasons for updating

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

Updated on 4 March 2011 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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Section 4.8
- update the clinical data in the 'Malignancies and Lymphoproliferative Disorders' section.

Section 5.1
- update the clinical data in the 'Psorasis' section.

Updated on 2 March 2011 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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In section 4.8 (Undesirable effects) addition of  Sarcoidosis and Pulmonary Fibrosis to Table 2.

Updated on 18 February 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 October 2010 PIL

Reasons for updating

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

Updated on 20 September 2010 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

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Section 4.4 - reformatted
Section 4.7 - visual impairment added
Section 4.8 - pleural effusion added to Table 2

Updated on 23 July 2010 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

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SPC updated for Chron's disease related parts of the SPC based on clinical trial data.
In section 4.1 (Indications): removal of concomitant treatment with steroids at induction.
In section 4.8 (undesirable effects) & 5.1 (pharmacological properties): updated with clinical trial results.
In section 9.0 (Date of first Authorisation/Renewal of Authorisation): date of first authorisation added.

Updated on 28 June 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 June 2010 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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In section 4.4 (Special warnings and precautions for use) an additional statement has been added on the increased risk of infections in the elderly population.

Updated on 1 June 2010 PIL

Reasons for updating

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

Updated on 27 May 2010 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use

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In section 4.4 minor change to 'Haematologic reactions' section
In section 4.8 additional undesirable effects added to 'Table 2'

Updated on 19 April 2010 SPC

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

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Section 4.4, Special warnings and precautions for use has been updated to add the text listed below under the following headings

 

Other opportunistic infections

Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.

 

Malignancies and lymphoproliferative disorders

Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.

Deletion of the following information

Psoriasis: New-onset and Worsening

Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, and cases of worsening of pre-existing psoriasis have been reported with the use of TNF-blockers, including Humira. Many of these patients were taking concomitant immunosuppressants (e.g., MTX, corticosteroids). Some of these patients required hospitalization. Most patients had improvement of their psoriasis following discontinuation of their TNF-blocker. Some patients have had recurrences of the psoriasis when they were re-challenged with a different TNF-blocker. Discontinuation of Humira should be considered for severe cases and those that do not improve or that worsen despite topical treatments.

 

Section 4.8 Undesirable effects

Leukemia has been added to Table 2

 

Section 10 Date of revision of text

Has been updated to March 2010

Updated on 20 January 2010 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

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The MAH address has been changed

Updated on 16 September 2009 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
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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In section 4.2 the dose interruption section has been updated and moved to under RA
In section 4.4 the word parasitic has been added under serious infections
In section 4.8 the system organ class Hepato-biliary disorders in Table 1 has been updated to add very common - elevated liver enzymes
In section 4.8 table 2 has been updated to add cerebrovascular accident, new onset or worsening of psoriasis (includinf palmoplantar pustular psoriasis and cardiac disorders- myocardial infection
In section 10 the date of revision has been updated to August

Updated on 10 August 2009 SPC

Reasons for updating

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

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Section 4.8: Table 1 frequencies have been updated to add more information under the categories of very common and common. The order of Table 2 has been updated.

Section 10: date of revison has been updated to July 2009

Updated on 10 August 2009 PIL

Reasons for updating

  • Change to side-effects

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 11 March 2009 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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Section 4.4: Update to section under Infections (more information about patients with TB), Serious Infections (new infections added), other Opportunistic infections (more information on infections and signs and symptoms of infections).

Section 4.8: Update to Table 1 and Table 2, section on Neoplasms benign and section under Infections to add extrapulmonary, blastomycosis, coccidioidomycosis, pneumocystis and candidiasis and delete pneumocystis carinii pneumonia.

Section 5.1:  Typographical changes

Section 6.3: Update to shelf life

Section 10: Date of revision changed to February 2009

 

Updated on 29 October 2008 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

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Change to indications
 
Added;

Polyarticular juvenile idiopathic arthritis

Updated on 10 October 2008 PIL

Reasons for updating

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

Updated on 2 September 2008 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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Update to section 4.8 of the SPC to add Hepatosplenic T-cell lymphoma as a side effect

Updated on 29 August 2008 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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Change to section 4.4 pf SmPC

Updated on 26 August 2008 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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Addition of Hepatosplenic T-cell lymphoma on section 4.4 and 4.8

Updated on 26 August 2008 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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Update to section 4.4, 4.5, 5.1 of SPC

Updated on 7 April 2008 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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The changes are the addition of :-
'Humira has been shown to reduce the
rate of progression of peripheral joint damage as measured by X-ray in
patients with polyarticular symmetrical subtypes of the disease (see
Section 5.1) and to improve physical function.' to the PsA indication.

Updated on 28 January 2008 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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Addition to Psorisis indication to section 4.1 of SPC

Updated on 16 January 2008 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 31 October 2007 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

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Change to section 4.8 undesiarable effects - addition of Pancreatitis

Updated on 30 July 2007 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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Update to section 5.1 Pharmacodynamic properties in-line with new clincal trial data

Updated on 18 July 2007 PIL

Reasons for updating

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

Updated on 18 June 2007 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

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Update to sections 4.1 and 4.8.
 
Update to section 4.1:-
 

Crohn’s disease

 

Humira is indicated for treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

For induction treatment, Humira should be given in combination with corticosteroids.  Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).

Updated on 15 June 2007 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

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Change to section 4.1 - Therapeutic Indications
Change to section 4.8 - Undesirable Effects

Updated on 25 April 2007 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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Update to section 4.4 Special Warnings and Precautions for Use

Updated on 23 February 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 February 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 November 2006 SPC

Reasons for updating

  • New SPC for medicines.ie

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