Imraldi 40mg solution for injection in pre-filled pen

  • Name:

    Imraldi 40mg 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: 29/10/20

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Summary of Product Characteristics last updated on medicines.ie: 29/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Biogen Biosimilar

biogenbiosimilar_1576666433

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Medicine Name Flixabi 100 mg powder for concentrate for solution for infusion Active Ingredients Infliximab
Medicine Name Imraldi 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
1 - 0 of 6 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 29 October 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

The following information was added to section 3:

Paediatric population

Imraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer Imraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

Section 6 was updated as follows:

Name and address of the manufacturer(s) responsible for batch release

 Biogen (Denmark) Manufacturing ApS

Biogen Allé 1

3400 Hillerød

Denmark

 Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Section 7 was updated as follows:

You may see 1 or more bubbles, and that is okay

 

Updated on 29 October 2020

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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

The following changes have been made:

Section 4.1, 4.2 and 5.1: Update of Imraldi PI to align with originator re wording for NSAIDs:

…non-steroidal anti-inflammatory drugs (NSAIDs)

non-steroidal anti-inflammatory drugs (NSAIDs)

Section 4.2- the following text has been added:

Paediatric population

Imraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer Imraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

Updated on 21 October 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4 has been updated to include the following:

  • Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin.

Updated on 21 October 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 has been updated to include Kaposi’s sarcoma as an undesirable effect.

Updated on 31 March 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 7 February 2020

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

Free text change information supplied by the pharmaceutical company

Changes to section 4.4 and section 4.6 were of a formatting nature only.

Changes to section 5.1 were as follows:

…..Uvetis

The following paragraph was added:

'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 adalimumab.'...

the following paragraph has been updated from:

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.

to:

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 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose. 

Also, section 1 has been updated as follows:

  • non-infectious uveitis affecting the back of the eye.

 

Updated on 11 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose. 

Also, section 1 has been updated as follows:

  • non-infectious uveitis affecting the back of the eye.

 

Updated on 11 September 2019

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.2 of the SPC has been updated. Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose.  

Updated on 30 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 30 April 2019

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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.2: The Patient Alert card has been renamed as 'Patient Reminder Card'

Section 4.4:The Patient Alert card has been renamed as 'Patient Reminder Card'

Updated on 16 April 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 April 2019

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

The previous version of this SPC uploaded was not a consolidated version, and did not include the approved updates of the paed. uveitis indication. This version corrects the error.

Updated on 2 April 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 2 April 2019

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.4 - the storage conditions at room temperature (25C) have been extended from a maximum of 14 to a maximum of 28 days.

Updated on 11 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to further information section

Updated on 11 March 2019

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 has been updated to include the following text:

Paediatric Uveiti

Imraldi 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 been updated to include the following text:

Paediatric uveitis

 The recommended dose of Imraldi for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). Imraldi is administered via subcutaneous injection.

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

 

Table 5 Imraldi Dose for Paediatric Patients with Uveitis

 

Patient Weight

Dosing Regimen

< 30 kg

-

≥ 30 kg

40 mg every other week in combination with methotrexate

- Not applicable, Imraldi is only available as 40 mg pre-filled syringe and pre-filled pen

 

When Imraldi therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2).

 There is no relevant use of adalimumab 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).

 - Section 4.8 been updated to include the following text:

No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.

  - Section 5.1 been updated to include the following text:

Paediatric Uveitis

 The safety and efficacy of adalimumab 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 3, 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]).

  -Section 5.2 been updated to include the following text:

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.

 

Updated on 27 November 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 November 2018

Reasons for updating

  • New SmPC for new product

Free text change information supplied by the pharmaceutical company

New product.