Kyntheum 210 mg Solution for Injection

Product Information *

  • Company:

    LEO Pharma
  • Status:

    No Recent Update
  • Active Ingredients * :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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 24 July 2020

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 23 July 2020

Reasons for updating

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

Amendment of wording regarding Crohn’s Disaese:

Previous warning regarding Crohn’s disease has been updated with a statement that Kyntheum is not recommended in patients with Inflammatory bowel disease (including Crohn's disease and ulcerative colitis).

New statement added:

Hypersensitivity reactions

Rare cases of anaphylactic reactions have been reported in the post-marketing setting. In the event of an anaphylactic reaction, or any other serious allergic reaction, administration of Kyntheum should be discontinued and appropriate therapy initiated.

Deletion of statement:

Reduced absolute neutrophil count

During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible. Grade 3 and 4 has been observed occasionally. None of the Grade 3 or 4 ANC decreases in the psoriasis patients were associated with a serious infection (see also section 4.8).’

 Section 4.8 Undesirable Effects

 Changes have been made based on post-marketing experience.

 Neutropenia has been reclassified from Common to Uncommon

 Anaphylactic reaction has been added with a frequency ‘rare’

Statement added:

‘Inflammatory bowel disease

Cases of new or exacerbations of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) have been reported with IL‑17 inhibitors (see section 4.4).’

Reporting of side effects details updated for HPRA

Section 5.1 Pharmacodynamic Properties

  • Text updates in clinical efficacy and safety section. See wording in SmPC attached.

 

Section 5.2 Pharmokinetic Properties

  • Text updates in absorption section. See wording in SmPC attached.

Section 6.6     Special precautions for disposal and other handling

  • The description ‘grey’ has been removed in relation to the needle cap

 

 

Updated on 18 November 2019

Reasons for updating

  • 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

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

Updated on 18 November 2019

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

Update of section 5.1 of the SmPC, “Mechanism of action” subsection, with information about the inhibition of cytokine IL-17C.

Updated on 02 November 2018

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 July 2018

Reasons for updating

  • Improved presentation of PIL

Updated on 02 October 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 02 October 2017

Reasons for updating

  • New PIL for new product

Updated on 28 September 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 25 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 25 September 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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

- In Section 6.5 a new pack size, a multipack of three packs of two pre-filled syringes has been added. A statement that not all pack sizes may be marketed has been added.
- In Section 8 a new marketing authorisation number associated with the new pack size has been added.
- In Section 10 the date of revision has been updated.

Updated on 21 July 2017

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 21 July 2017

Reasons for updating

  • New PIL for new product