AUBAGIO 14 mg film-coated tablets

  • Name:

    AUBAGIO 14 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Teriflunomide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/11/19

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

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Sanofi Genzyme

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Company Products

Medicine NameActive Ingredients
Medicine Name Aldurazyme 100 U/ml concentrate for solution for infusion Active Ingredients Laronidase
Medicine Name AUBAGIO 14 mg film-coated tablets Active Ingredients Teriflunomide
Medicine Name Caprelsa 100mg and 300mg film coated tablets Active Ingredients Vandetanib
Medicine Name Cerdelga 84 mg capsules, hard Active Ingredients Eliglustat tartrate
Medicine Name Cerezyme 400 U Powder for concentrate for solution for infusion Active Ingredients Imiglucerase
Medicine Name Cholestagel 625mg film coated Tablets Active Ingredients Colesevelam hydrochloride
Medicine Name Evoltra 1 mg/ml concentrate for solution for infusion Active Ingredients Clofarabine
Medicine Name Fabrazyme 35 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
Medicine Name Fabrazyme 5 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
Medicine Name Fasturtec Active Ingredients Rasburicase
Medicine Name Fludara 50 mg powder for solution for injection or infusion Active Ingredients Fludarabine Phosphate
Medicine Name Fludara oral 10 mg film-coated tablets Active Ingredients Fludarabine Phosphate
Medicine Name LEMTRADA 12 mg concentrate for solution for infusion Active Ingredients Alemtuzumab
Medicine Name Mozobil 20 mg ml solution for injection Active Ingredients Plerixafor
Medicine Name Myozyme 50 mg, powder for concentrate for solution for infusion. Active Ingredients Alglucosidase alfa
Medicine Name Thymoglobuline 25 mg powder for solution for infusion Active Ingredients Rabbit Anti-Human Thymocyte Immunoglobulin
Medicine Name Thyrogen 0.9 mg powder for solution for injection Active Ingredients Thyrotropin alfa
1 - 0 of 17 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 20 November 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 November 2019 PIL

Reasons for updating

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

Updated on 11 November 2019 SmPC

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 PIL

Reasons for updating

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

Updated on 11 October 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 11 October 2019 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 24 May 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 22 May 2019 PIL

Reasons for updating

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

Updated on 22 May 2019 SmPC

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 4 April 2019 PIL

Reasons for updating

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

Updated on 8 March 2019 PIL

Reasons for updating

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

Updated on 8 March 2019 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • XPIL Created

Updated on 25 July 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 5 June 2018 SmPC

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 5 June 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 July 2017 SmPC

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 5 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 July 2017 PIL

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 5 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 May 2017 PIL

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 15 May 2017 SmPC

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 9 December 2015 SmPC

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 9 December 2015 PIL

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 8 July 2015 SmPC

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 8 July 2015 PIL

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 9 December 2014 SmPC

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 9 December 2014 PIL

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 7 October 2014 SmPC

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 7 October 2014 PIL

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 PIL

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 22 September 2014 SmPC

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 30 July 2014 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 30 July 2014 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided