Caprelsa 100mg and 300mg film coated tablets

Product Information *

  • Company:

    Sanofi Genzyme
  • 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 19 February 2021

File name

1.3.2 Mock-up PIL-Waterford_1613724621.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

Updated on 07 January 2021

File name

1.3.1 SPC-UK (includes IE and MT)_1610019817.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 07 January 2021

File name

1.3.1 PIL text-UKIEMT (1)_1610017515.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 21 November 2019

File name

Caprelsa SPC_1574336444.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 21 November 2019

File name

Caprelsa PIL IE_1574336308.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

EDM Updated on 11 October 2019

File name

RMP CAPRELSA HCP GUIDE ELECTRONIC CERTIFIED 29.11.17_1570791773.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

Sanofi Letterhead HCP Letter ELECTRONIC CERTIFIED 30.11.17_1570791773.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

PATIENT ALERT CARD ELECTRONIC CERTIFIED 29.11.2017_1570791773.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

RMP CAPRELSA PATIENT GUIDE ELECTRONIC CERTIFIED 29.11.17_1570791603.pdf

Reasons for updating

  • Add New Doc

Updated on 04 June 2019

File name

1.3.2 Mock-up PIL-Waterford_1559659845.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 20 March 2019

File name

PIL Caprelsa IE-MT (UK removed)_1553084036.pdf

Reasons for updating

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

Updated on 20 March 2019

File name

SPC Caprelsa IE and MT (UK removed)_1553083993.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

    1. Undesirable effects
       
      Summary of the safety profileOverall summary of adverse reactions
      The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
       
      Tabulated list of adverse reactionsAdverse reactions during clinical trials
      The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC. Their frequency is presented in Table 2, adverse reactions using Council for International Organizations of Medical Sciences (CIOMS III), listed by MedDRA System Organ Class (SOC) and at the preferred term level and then by frequency classification. Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). This section includes only data derived from completed studies where patient exposure is known.

 

Description of selected adverse reactions

Events such as Torsades de pointes, Stevens‑Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy. It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.

 

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.

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 17 February 2012

 

Date of latest renewal: 15 January 201909 February 2018

 

Updated on 14 March 2019

File name

PIL Caprelsa 100mg and 300mg SA181_1552564660.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 14 March 2019

File name

SPC Caprelsa 100mg and 300mg SA181_1552565170.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 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

    1. Undesirable effects
       
      Summary of the safety profileOverall summary of adverse reactions
      The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
       
      Tabulated list of adverse reactionsAdverse reactions during clinical trials

 

** including two deaths in patients with QTc > 550 ms (one due to sepsis and one due to heart failure)

 

Description of selected adverse reactions

Events such as Torsades de pointes, Stevens‑Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy. It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.

 

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.

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 17 February 2012

 

Date of latest renewal: 15 January 201909 February 2018

 

 

10.     DATE OF REVISION OF THE TEXT

 

 

 

Updated on 14 January 2019

File name

PIL Caprelsa 100mg and 300mg fc tablets_1547470652.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 2019

File name

SPC Caprelsa 100 and 300mg _1547471434.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 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

7.       MARKETING AUTHORISATION HOLDER

 

Genzyme Europe BV

Paasheuvelweg 25,

1105 BP Amsterdam,

The Netherlands,

Tel: +31 (0)35 699 12 00

Fax: +31 (0) 35 694 32 14

Updated on 02 August 2018

File name

SPC-clean_1533201670.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.3 of the SmPC to reflect the results from pre-clinical study titled “ZD6474: A 104 Week Carcinogenicity Study by Oral Gavage in Rats

Updated on 06 June 2018

File name

Caprelsa 100mg & 300mg film-coated tablets SPC.docx

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 5.3  Carcinogenicity

Removed:-

  • Vandetanib has shown no carcinogenic potential in a transgenic mouse carcinogenicity study.

Added:-

  •  Vandetanib has shown no carcinogenic potential effect in a 6 month carcinogenicity study in rasH2 transgenic mice. A 2-year carcinogenicity study in rats was impaired by low survival in the high dose female group and limited exposure of the animals to vandetanib; however, no carcinogenic effects were observed in the remaining animals.

Updated on 05 April 2018

File name

PIL_16032_752.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 April 2018

Reasons for updating

  • Improved presentation of PIL

Updated on 14 March 2018

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 March 2018

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

Section 5.1  added:-
 
Information on overall survival based on the addendum to clinical study report from the study D4200C00058 (cut-off date 2015): An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer. In addition, the Marketing authorisation holder took the opportunity to update the list of local representatives in the Package Leaflet

Updated on 14 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 14 March 2018

File name

PIL_16032_115.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 February 2018

Reasons for updating

  • Improved presentation of PIL

Updated on 22 December 2016

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Extension of Indication to include paediatric patients aged 5 to 18 with unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC) for Caprelsa; as a consequence, sections 4.1, 4.2, 4.4, 4.6, 4.8, 5.1 and 5.2 of the SmPC are updated. Other minor changes to the SmPC also included aligning to the QRD template.

Updated on 22 December 2016

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - manufacturer

Updated on 22 September 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7: MAH has been transferred from AstraZeneca AB to Genzyme Europe B.V.

Updated on 22 September 2016

Reasons for updating

  • Change to further information section
  • Change to marketing authorisation holder

Updated on 03 February 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • 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 9 - Date of renewal of 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

4.2 Minor editorial- correction of spelling

4.3 Minor editorial update

4.4 minor update to skin reactions text, editorial update and correction of spelling

4.5 minor editorial update and correction of spelling

4.8 minor editorial and correction of spelling

5.1 minor editorial

5.2 minor editorial

5.3 minor editorial

9 date of renewal added

10 revision date amended

Updated on 03 February 2016

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 22 December 2015

Reasons for updating

  • Previous version of SPC reinstated

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

Free text change information supplied by the pharmaceutical company

Document reverted back to previously approved version of the SmPC

Updated on 11 December 2015

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of 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

Section 4.3 minor editorial change, correction of spelling

Section 4.4 update to skin reaction sections and minor editorial change (correction in spelling)

Section 4.5 minor editorial change, correction of spelling

Section 5.1 minor editorial change, correction of spelling

Section 5.2 minor editorial change, correction of spelling

Section 9 date of renewal added

Section 10 updated revision date

Updated on 12 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 – Amendment of MT ADR reporting address in line with latest QRD Appendix V.
Update to date of revision

Updated on 08 May 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 05 November 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • 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 4.8          Update AE reporting details in line with QRD

Section 5.3          Update with details that Vandetanib has shown no carcinogenic potential in a transgenic mouse carcinogenicity study.

Section 10           Update to date of revision

Updated on 31 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 01 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 01 July 2014

Reasons for updating

  • New PIL for new product