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Jevtana

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Cabazitaxel

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

Updated on 11 September 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Jevtana (4).pdf

Reasons for updating

  • Other

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

Updated on 11 September 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Jevtana (1).pdf

Reasons for updating

  • Change to other sources of information section

Updated on 26 April 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Jevtana.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 April 2023

File name

1.3.1.3 Package Leaflet (PIL text) Jevtana.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

Updated on 03 April 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Jevtana (3).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 03 April 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Jevtana (3).pdf

Reasons for updating

  • New SPC for new product

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

Updated on 28 March 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Jevtana (2).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 28 March 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL)- Jevtana (1).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

Updated on 08 July 2022

File name

1.3.2 Mock-up-leaflet- IE-MT only (2).pdf

Reasons for updating

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

Updated on 07 June 2022

File name

1.3.1.1 SmPC - IE & UK(NI).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)

Updated on 10 March 2022

File name

Jevtana 1.3.2 Mock-up-leaflet- IE-MT only.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 12 March 2021

File name

1.3.1.1 SmPC - IE (1).pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Updated on 12 March 2021

File name

1.3.2 Mock-up-leaflet- IEMT only.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 March 2021

File name

1.3.2 Mock-up-leaflet- IEMT only.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 03 March 2021

File name

1.3.1.1 SmPC - IE.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 11 February 2021

File name

1.3.2 Mock-up-leaflet- IE-MT only.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 December 2020

File name

1.3.1.1 SmPC - IE.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • 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 06 July 2020

File name

Jevtana PIL.pdf

Reasons for updating

  • XPIL Removed

Updated on 08 October 2019

File name

Jevtana PIL.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 June 2018

File name

PIL Jevtana 60mg concentrate for solution for infusion.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 03 May 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

 Update of sections 4.2, 4.8 and 5.1 of the SmPC in order to add information from completed study EFC11785 (Randomized, open-label multicenter study comparing cabazitaxel at 20 mg/m2 and at 25 mg/m2 every 3 weeks in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen). In addition, the MAH is proposing to modify the wording in section 4.1 of the indication from “hormone refractory” to “castration resistant” prostate cancer to reflect current terminology of the disease in the clinical practice. The RMP is updated accordingly and in accordance with the request from the latest PSUR procedure (EMEA/C/H/002018/PSUSA/000476/201506).

Updated on 07 April 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 of the SmPC to add the Adverse Drug Reaction Cystitis due to radiation recall phenomenon with an uncommon frequency. The package leaflet is updated accordingly. In addition the MAH took the opportunity to update the local representative for Bulgaria

Updated on 05 April 2017

File name

PIL_15400_823.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 April 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 December 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Update of sections 4.2 and 5.1 of the SmPC in order to add information from study TED12689, a phase 1-2 dose finding, safety and efficacy study of cabazitaxel in paediatric patients with refractory solid tumours including tumours of the central nervous system in line with article 46 of the paediatric regulation (EC) No 1901/2006 – CCDS v8

Updated on 05 December 2016

Reasons for updating

  • 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 21 April 2016

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 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



Type II CCDS approval v.7 for Respiratory disorders + approval for the

removal of the black triangle

Updated on 20 April 2016

Reasons for updating

  • Change to side-effects

Updated on 03 February 2016

Reasons for updating

  • 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

Date of renewal updated

Updated on 09 July 2015

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 5.2 - Pharmacokinetic 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 4.2: paragraph below updated: 

Special populations

Patients with hepatic impairment

Section 4.3 minor change to third bullet point.

Section 4.4 - paragraph regarding patients with liver impairment updated.

Section 5.2: Hepatic impairment paragraph updated.

Updated on 06 May 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic 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 4.2 - paragraph updated.
Section 4.4 - paragraph 'Risk of renal failure' updated to include 'any degradation of renal function to' in relation to the discontinuation of Cabazitazel treatment.
Section 5.2 - paragraph 'Renal impairment' updated to include new information from a recent study.

Updated on 14 August 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: updated to amend the current warning on the risk of anemia in patients.

Updated on 28 May 2014

Reasons for updating

  • Change to further information section

Updated on 28 May 2014

Reasons for updating

  • Change to improve clarity and readability

Updated on 28 February 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • 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 2: note added regarding an overfill to compensate for liquid loss during preparation.
Section 4.2: Method of Administration updated to state that Jevtana must not be mixed with any other medicinal products other than those listed in section 6.6.
Section 6.5: the word 'entire' bolded.
Section 6.6: new section included regarding the mixing and diluting of Jevtana.

Updated on 06 February 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic 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 4.2 updated:  Older people changed to Elderly

and in Concomitant medicinal products use text included:

However, if patients require co‑administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections 4.4 and 4.5).

Section 4.4 updated: Older people changed to Elderly
Interactions paragraph - text included:     ). If co‑administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see sections 4.2 and 4.5).

Section 4.5: paragraphs on CYP3A inhibitors and CYP3A inducers is updated based on the results from study TCD10870

 

CYP3A inhibitors

Repeated administration of ketoconazole (400 mg once daily), a strong CYP3A inhibitor, resulted in a 20% decrease in cabazitaxel clearance corresponding to a 25% increase in AUC. Though no formal drug interaction trials have been conducted for cabazitaxel,Therefore concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) is expected to increase concentrations of cabazitaxel. Therefore, co‑administration with strong CYP3A inhibitors should be avoided as an increase of plasma concentrations of cabazitaxel may occur. Caution should be exercised with concomitant use of moderate CYP3A inhibitors (see sections 4.2 and 4.45.2).

 

Concomitant administration of aprepitant, a moderate CYP3A inhibitor, had no effect on cabazitaxel clearance.

 

CYP3A inducers

Repeated administration of rifampin (600 mg once daily), a strong CYP3A inducer, resulted in an increase in cabazitaxel clearance of 21% corresponding to a decrease in AUC of 17%.

Therefore Though no formal drug interaction trials have been conducted for cabazitaxel, the concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) is expected to decrease cabazitaxel concentrations. Therefore, co‑administration with strong CYP3A inducers should be avoided as a decrease of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.45.2). In addition, patients should also refrain from taking St. John’s Wort.


Section 5.2: the following text is deleted from the Biotransformation paragrah -

Potent CYP3A inductor or inhibitor could affect the plasma concentration of cabazitaxel, as cabazitaxel is mainly metabolised by CYP3A.

Prednisone or prednisolone administered at 10 mg daily did not affect the pharmacokinetics of cabazitaxel.

 

Updated on 13 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of black triangle

Updated on 18 June 2013

Reasons for updating

  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Addition of Black Triangle.
Section 4.4: new paragraphs included - 'Gastrointestinal disorders' and 'Risk of serious gastrointestinal reactions'.
Section 4.8: new paragraphs included - 'Gastrointestinal disorders' and 'Reporting of suspected adverse reactions'.

Updated on 07 February 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic 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 4.5 & 5.2 updated with the results of POP6792 study (drug interaction study with midazolam in patient with normal hepatic function)

Updated on 03 October 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 4.5 - risk of interaction with OATP1B1 substrates added
Section 5.2 - results of the TRE0035 in vitro study are reported
Section 6.5 - addition of information on overfill for the concentrate and solvent vials

All other sections have been updated according to the QRD template version 8, with editorial changes in sections 6.3, 6.4 and 6.6

Updated on 27 September 2012

Reasons for updating

  • Change to storage instructions
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Correction of spelling/typing errors

Updated on 26 July 2012

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 has been updated to change the MAH name and address from SANOFI - 174, avenue de France - 75013 Paris to sanofi-aventis groupe - 54, rue La Boetie - 75008 Paris

Updated on 09 July 2012

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 27 June 2012

Reasons for updating

  • New PIL for new product