Humira 80 mg solution for injection in pre-filled pen

  • Name:

    Humira 80 mg solution for injection in pre-filled pen

  • 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: 22/11/19

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Summary of Product Characteristics last updated on medicines.ie: 22/11/2019

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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 22 November 2019 PIL

Reasons for updating

  • Change to further information section

Free text change information supplied by the pharmaceutical company

Chnage to Section 7 - Injection Humira (sections 6, 7 and 8)

Updated on 22 November 2019 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

  • Section 4.1 Therapeutic indications
    Editorial change

    Rheumatoid arthritis

    The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Humira.

    Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira.  Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.

    Amended to:

    The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Humira.

    Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics can be continued during treatment with Humira.  Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.

 

 

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

 

Updated on 27 May 2019 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

The following updates have been made to section 5.1 of the SmPC:

 

  • Additional text describing enrolment into long term extension study
     Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks. Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira.
     
  • Revision of study summary
    • Revision of subject numbers
    • Explanation that the number of enrolled subjects declined but data at later timepoints generally consistent with week 78
    • Updated overall numbers for discontinuations based on full duration of study
      Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment. Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade  ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2%) were in steroid-free quiescence. BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78. Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time. Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
       
       
      Date of Revision of text: updated to 05/2019

Updated on 11 March 2019 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 9 November 2018 PIL

Reasons for updating

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

Updated on 9 November 2018 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

 

  • Section 4.2 and section 4.4: “Patient Alert Card” changed to “Patient Reminder Card”.

Updated on 1 August 2018 PIL

Reasons for updating

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

Updated on 1 August 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Summary of Changes

Section  4.8

  • Revised to include “lichenoid skin reaction” as a rare event under Skin and subcutaneous tissue disorders

 

Section 10

  • Date of Revision of Text updated to 26 July 2018

 

Section 6.5

  • The following presentation has been added:

    3 pre-filled pens (0.8 ml sterile solution), with 4 alcohol pads in a blister.

Updated on 4 July 2018

Updated on 3 July 2018 SmPC

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 8 May 2018 SmPC

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 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
    • Rheumatoid arthritis indication added
  • 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
    • Clinical efficacy and safety data added for Rheumatoid arthritis
    • Immunogenicity data from rheumatoid arthritis studies I, II and III added
  • Section 5.2, Pharnacokinetic properties
    • Pharmacokinetic data relating to rheumatoid arthritis added
    • The following text has been added:

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

 

Updated on 4 May 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 SmPC

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 SmPC

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 13 February 2018 SmPC

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

None provided

Updated on 12 February 2018 PIL

Reasons for updating

  • New PIL for new product