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AUBAGIO 14 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Teriflunomide

    *Additional information is available within the SPC or upon request to the company

Updated on 11 November 2024

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg (6).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 November 2024

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg (3) (1).pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 11 November 2024

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg (5).pdf

Reasons for updating

  • Improved presentation of PIL

EDM Updated on 02 October 2024

File name

Patient Card - Aubagio IE (1).pdf

Reasons for updating

  • Replace File

Updated on 01 October 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (6).pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 24 September 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (5).pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 22 August 2024

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg (3).pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 01 August 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (4).pdf

Reasons for updating

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

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

EDM Updated on 23 July 2024

File name

HCP Guide - Aubagio IE.pdf

Reasons for updating

  • Replace File

EDM Updated on 23 July 2024

File name

Patient Card - Aubagio IE.pdf

Reasons for updating

  • Replace File

Updated on 07 May 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (3).pdf

Reasons for updating

  • 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 07 May 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 22 June 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 March 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL)- Aubagio 7mg.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 29 November 2022

File name

1.3.1 SmPC IENIMalta (1).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 07 January 2022

File name

1.3.2.1 Mock-up Leaflet - 14MG - IE-MT-UK(NI).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

EDM Updated on 03 December 2021

File name

AUB-2021-061_HCP_Discussion_Guide_IE_V7.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 December 2021

File name

AUB-2021-060_Aubagio_Patient_Card_IE_MAT-IE-2101438 v2.0.pdf

Reasons for updating

  • Replace File

Updated on 13 September 2021

File name

1.3.2.1 Mock-up Leaflet - IE-MT (2).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 09 September 2021

File name

Aubagio 1.3.2.1 Mock-up Leaflet - IE-MT (1).pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 July 2021

File name

1.3.1 SmPC IENIMalta (2).pdf

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

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

Updated on 13 July 2021

File name

1.3.1 SmPC IENIMalta (1).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

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

Updated on 13 July 2021

File name

1.3.2.1 Mock-up Leaflet - IE-MT.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • 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 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 June 2021

File name

1.3.1 SmPC IENIMalta.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • 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)

Updated on 22 March 2021

File name

1.3.2.1 Mock-up Leaflet - IE-MT (1).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 15 February 2021

File name

1.3.1 SPC (7).pdf

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

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

Updated on 15 February 2021

File name

1.3.1 Leaflet text IEMT (1).pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 09 November 2020

File name

1.3.2 PIL Mock-up IE-MT.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 September 2020

File name

1.3.1 SPC (3).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2 - Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate) and 0.3 mg of sodium. 
  • Section 4.4 -  Sodium - This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.

Updated on 16 September 2020

File name

1.3.1 PIL (5).pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

EDM Updated on 08 July 2020

File name

AUB-2020-009_HCP_Discussion_Guide_IE_2pp 12.6.20.pdf

Reasons for updating

  • Replace File

EDM Updated on 08 July 2020

File name

AUB-2020-010_Patient_Alert_Card_IE 12.6.20.pdf

Reasons for updating

  • Replace File

EDM Updated on 24 June 2020

File name

AUB-2020-009_HCP_Discussion_Guide_IE_2pp 12.6.20.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

To increase patients’ knowledge about symptoms of liver problems and infections in the patient Card

•             To add instructions to the HCPs regarding the enrolment of patients in the pregnancy registry in the HCP Guide

•             To ensure that the content of Patient Card will be discussed by the HCP during each regularly during each consultation

EDM Updated on 24 June 2020

File name

AUB-2020-010_Patient_Alert_Card_IE 12.6.20.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

To increase patients’ knowledge about symptoms of liver problems and infections in the patient Card

•             To add instructions to the HCPs regarding the enrolment of patients in the pregnancy registry in the HCP Guide

          

Updated on 20 November 2019

File name

Aubagio PIL.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 November 2019

File name

Aubagio PIL.pdf

Reasons for updating

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

Updated on 11 November 2019

File name

Aubagio SPC.pdf

Reasons for updating

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

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

Updated on 11 November 2019

File name

Aubagio PIL.pdf

Reasons for updating

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

EDM Updated on 11 October 2019

File name

AUB-2018-017_RMP_Updates_-_HCP_Education_Guide.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

AUB-2018-017_RMP_Updates_-_Patient_card.pdf

Reasons for updating

  • Add New Doc

Updated on 24 May 2019

File name

PIL mock up Aubagio reissue SA1216.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 22 May 2019

File name

PIL Aubagio 14mg fc tablets SA1216.pdf

Reasons for updating

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

Updated on 22 May 2019

File name

SPC Aubagio 14mg fc tablets SA1216.pdf

Reasons for updating

  • 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 4.4

update with a warning concerning alcohol use with clarification of "with caution" term

Updated on 04 April 2019

File name

PIL Mock-up Aubagio SA1098.pdf

Reasons for updating

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

Updated on 08 March 2019

File name

PIL Aubagio 14mg film coated tablets SA1098.pdf

Reasons for updating

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

Updated on 08 March 2019

File name

SPC Aubagio 14mg film coated tablet SA1098.pdf

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Metabolism and nutrition disorders

 

 

 

 

 

Dyslipidaemia

Skin and subcutaneous tissue disorders

Alopecia

Rash, Acne

Nail disorders

 

 

Severe skin reactionsa

Nail disorders

Musculoskeletal and connective tissue disorders

 

Musculoskeletal pain,

Myalgia, Arthralgia

 

 

 

 

Renal and urinary disorders

 

Pollakiuria

 

 

 

 

Reproductive system and breast disorders

 

Menorrhagia

 

 

 

 

General disorders and administration site conditions

 

Pain, Astheniaa

 

 

 

Asthenia

Investigations

 

Weight decrease,

Neutrophil count decreaseb,

White blood cell count decreaseb, Blood creatine phosphokinase increased

 

 

 

 

Injury, poisoning and procedural complications

 

 

Post-traumatic pain

 

 

 

 

a: please refer to the detailed description section

b: see section 4.4

 

Severe skin reactions

Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).

 

Asthenia

In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.

 

Reporting of suspected adverse reactions

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

 

4.9     Overdose

 

 

Long term follow-up results from TEMSO long term extension safety study (overall median treatment duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any new or unexpected safety findings.

 

 

 

Updated on 21 December 2018

File name

PIL Mock up Aubagio 14mg film coated tablets.pdf

Reasons for updating

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

Updated on 21 December 2018

File name

SPC Aubagio 14mg film coated tablet .pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Hepatobiliary disorders

Alanine

aminotransferase (ALT) increaseb

Gamma-glutamyltransferase (GGT) increaseb,

Aspartate aminotransferase increaseb

 

 

 

Acute hepatitis

Metabolism and nutrition disorders

 

 

 

 

 

Dyslipidaemia

Skin and subcutaneous tissue disorders

Alopecia

Rash,

Acne

 

 

 

Severe skin reactionsa

Nail disorders

 

 

 

 

Reporting of suspected adverse reactions

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

 

Updated on 24 October 2018

File name

Aubagio 14mg film-coated tablets PIL.pdf

Reasons for updating

  • XPIL Created

Updated on 25 July 2018

File name

Aubagio 14mg film-coated tablets PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 05 June 2018

File name

AUBAGIO 14mg film-coated tablets SPC.docx

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

  • Removal of black triangle

Section 4.3 Contraindications

AIDs removed and replaced with acquired immunodeficiency syndrome (AIDS).

Section 4.4 Special warnings and precautions for use

Wording added into section:-

  • serum glutamic pyruvic transaminase
  • Check periodically
  • serum glutamic pyruvic transaminase
  • Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.

Hepatic effects:-

Wording removed from section:-

  • Liver enzymes should be assessed before initiation of teriflunomide therapy - every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.

Subtitle added:-

  • Hypoproteinaemia

Respiratory reactions  

Amendments to paragraph

  • Drug removed and replaced with medicinal product.
  • Consider removed and replaced with should be considered.

Lactose

Minor wording amendments to paragraph

Section 4.5 Interaction with other medicinal products and other forms of interaction

Grammatical errors amended and medicinal added into paragraph

Section 4.6 Fertility, pregnancy and lactation

Medicine replaced by medicinal product

Breast-feeding

Added

  • Teriflunomide is contraindicated during breast-feeding
  • (see section 4.3).

Removed

  • women must, therefore, not receive teriflunomide
  • Breast

Section 4.7          Effects on ability to drive and use machines

  • The word cars removed

Section 4.8          Undesirable effects

  • Minor amendments to tabulated list of adverse reactions

Section 5.1          Pharmacodynamic properties

Added:

  • Immunosuppressants,
  • Minor spelling amendments updated

 

Section 5.2          Pharmacokinetic properties

 

  • IV replaced with intravenous

Section 6.5          Nature and contents of container

  • Aluminium replaced with Polyamide/aluminium/poly(vinyl chloride)

Section 9

  • Renewal date added 28May2018

Updated on 05 June 2018

File name

AUGAGIO 14mg film-coated tablets Text Leaflet.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 July 2017

Reasons for updating

  • 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

IAIN To update section 4.4 of the SmPC and section 2 of the PL to implement the signal recommendations on 'Leflunomide; teriflunomide – Falsely decreased ionised calcium levels (EPITT no 18787)' adopted at the 3-6 April 2017 PRAC meeting

Updated on 05 July 2017

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

IAIN To update section 4.4 of the SmPC and section 2 of the PL to implement the signal recommendations on 'Leflunomide; teriflunomide – Falsely decreased ionised calcium levels (EPITT no 18787)' adopted at the 3-6 April 2017 PRAC meeting

Updated on 15 May 2017

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

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 4.8 of the SmPC to include the adverse drug reactions interstitial lung disease (ILD), acute hepatitis, asthenia and nails disorders with a frequency ‘not known’. Furthermore, alanine aminotransferase (ALT) increase, gamma-glutamyl transferase (GGT) increase and aspartate aminotransferase increase are moved from the SOC ‘Investigations’ to the newly introduced SOC ‘Hepatobiliary disorders’ with the same frequencies as before. Finally, the existing warning on respiratory reactions in section 4.4 of the SmPC has been updated in relation to ILD. The Package leaflet is updated accordingly. In addition, certain side-effects in the Package leaflet have also been moved under ‘serious side-effects’. RMP version 4.0 has been submitted and agreed; however, the conclusions drawn from the assessment of the current PSUR warrant further changes to the RMP to be submitted at the next opportunity.  The MAH has also taken the occasion to align the PI to QRD template version 10.0 and to update local representatives for Bulgaria, France and Hungary in the Package leaflet

Updated on 15 May 2017

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

Free text change information supplied by the pharmaceutical company

Update of section 4.8 of the SmPC to include the adverse drug reactions interstitial lung disease (ILD), acute hepatitis, asthenia and nails disorders with a frequency ‘not known’. Furthermore, alanine aminotransferase (ALT) increase, gamma-glutamyl transferase (GGT) increase and aspartate aminotransferase increase are moved from the SOC ‘Investigations’ to the newly introduced SOC ‘Hepatobiliary disorders’ with the same frequencies as before. Finally, the existing warning on respiratory reactions in section 4.4 of the SmPC has been updated in relation to ILD. The Package leaflet is updated accordingly. In addition, certain side-effects in the Package leaflet have also been moved under ‘serious side-effects’. RMP version 4.0 has been submitted and agreed; however, the conclusions drawn from the assessment of the current PSUR warrant further changes to the RMP to be submitted at the next opportunity.  The MAH has also taken the occasion to align the PI to QRD template version 10.0 and to update local representatives for Bulgaria, France and Hungary in the Package leaflet

Updated on 09 December 2015

Reasons for updating

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

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: Under Skin reactions the following update has been made;

Cases of severe skins reactions have been reported with teriflunomide postmarketing (including Stevens-Johnson syndrome, and toxic epidermal necrolysis).

 In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported as well. 

 

Section 4.8: The following additions to the Adverse Reactions table have been made; Headache, palpitations, arthralgia, blood creatine phosphokinase increased.

Addition of terms from post marketing safety reports for teriflunomide also included; Severe infections including sepsis, Hyper-sensitivity reactions (immediate or delayed)  including anaphylaxis and angioedema, Pancreatitis,  Stomatitis, Severe skin reactions. These terms have all been placed in the new column for frequency ‘Not known’. Consequentially, the following sentence has been added below the ADR table, under the heading for infections: “Severe infections including sepsis, sometimes fatal have been reported post marketing.”

Updated on 09 December 2015

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Under Skin reactions the following update has been made;

Cases of severe skins reactions have been reported with teriflunomide postmarketing (including Stevens-Johnson syndrome, and toxic epidermal necrolysis).

 In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported as well. 

 

Section 4.8: The following additions to the Adverse Reactions table have been made; Headache, palpitations, arthralgia, blood creatine phosphokinase increased.

Addition of terms from post marketing safety reports for teriflunomide also included; Severe infections including sepsis, Hyper-sensitivity reactions (immediate or delayed)  including anaphylaxis and angioedema, Pancreatitis,  Stomatitis, Severe skin reactions. These terms have all been placed in the new column for frequency ‘Not known’. Consequentially, the following sentence has been added below the ADR table, under the heading for infections: “Severe infections including sepsis, sometimes fatal have been reported post marketing.”

Updated on 08 July 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

4.4         Special warnings and precautions for use

Skin reactions

No cCases of severe skins reactions have been reported with teriflunomide postmarketing in the clinical trials. In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported as well.

4.8         Undesirable effects

Severe skin reactions

Cases of severe skins reactions have been reported with teriflunomide post-marketing (see section 4.4).

Updated on 08 July 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

4.4         Special warnings and precautions for use

Skin reactions

No cCases of severe skins reactions have been reported with teriflunomide postmarketing in the clinical trials. In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported as well.

4.8         Undesirable effects

Severe skin reactions

Cases of severe skins reactions have been reported with teriflunomide post-marketing (see section 4.4).

Updated on 09 December 2014

Reasons for updating

  • 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 4.4: Inclusion of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) under the skin reactions section in patients treated with the parent compound leflunomide.

Updated on 09 December 2014

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Inclusion of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) under the skin reactions section in patients treated with the parent compound leflunomide.

Updated on 07 October 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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 4.5: improvement of the oral contraceptive PK interaction wording.

Section 4.8 update of AEs vs placebo (i.e. data pool of all placebo-controlled phase2/3 clinical trials).

Section 5.1: addition of TOPIC efficacy study results.

Updated on 07 October 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 4.5: improvement of the oral contraceptive PK interaction wording.

Section 4.8 update of AEs vs placebo (i.e. data pool of all placebo-controlled phase2/3 clinical trials).

Section 5.1: addition of TOPIC efficacy study results.

Updated on 22 September 2014

Reasons for updating

  • 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

In section 4.4: Addition of two clinical study results in the vaccination paragraph as below;

From:

Vaccination

In a clinical study, teriflunomide-treated patients mounted appropriate immune responses to a seasonal influenza vaccination, consistent with the preservation of a response to booster vaccine. Patients reached post-vaccination antibody titres, consistent with seroprotection. No clinical data are available on the efficacy and safety of vaccinations regarding primary immune response to neopathogens. The use of live attenuated vaccines may carry a risk of infections and should, therefore, be avoided.

 

To:

Vaccination

 Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment . The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.

Updated on 22 September 2014

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

In section 4.4: Addition of two clinical study results in the vaccination paragraph as below;

From:

Vaccination

In a clinical study, teriflunomide-treated patients mounted appropriate immune responses to a seasonal influenza vaccination, consistent with the preservation of a response to booster vaccine. Patients reached post-vaccination antibody titres, consistent with seroprotection. No clinical data are available on the efficacy and safety of vaccinations regarding primary immune response to neopathogens. The use of live attenuated vaccines may carry a risk of infections and should, therefore, be avoided.

 

To:

Vaccination

 Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment . The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.

Updated on 30 July 2014

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 30 July 2014

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided