Last Updated on eMC 05-07-2017 View medicine  | Genzyme Therapeutics Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

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

Date of revision of text on the SPC:09-06-2017

Legal Category:POM

Black Triangle (CHM): YES

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.

Reasons for adding or 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

Date of revision of text on the SPC:21-04-2017

Legal Category:POM

Black Triangle (CHM): YES

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

Reasons for adding or updating:

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

Date of revision of text on the SPC:22-10-2015

Legal Category:POM

Black Triangle (CHM): YES

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.”

Reasons for adding or updating:

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

Date of revision of text on the SPC:19-06-2015

Legal Category:POM

Black Triangle (CHM): YES

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).

Reasons for adding or updating:

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

Date of revision of text on the SPC:19-11-2014

Legal Category:POM

Black Triangle (CHM): YES

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.

Reasons for adding or 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

Date of revision of text on the SPC:25-09-2014

Legal Category:POM

Black Triangle (CHM): YES

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

Section 5.1: addition of TOPIC efficacy study results.

Reasons for adding or updating:

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

Date of revision of text on the SPC:24-07-2014

Legal Category:POM

Black Triangle (CHM): YES

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.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES