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Jevtana

  • Name:

    Jevtana

  • Company:
    info
  • Active Ingredients:

    Cabazitaxel

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 3/5/2017
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SANOFI

SANOFI

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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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 8 October 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 June 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 3 May 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 3 May 2017 SPC

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 7 April 2017 SPC

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 5 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 April 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 December 2016 SPC

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 5 December 2016 PIL

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 SPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 3 February 2016 SPC

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 9 July 2015 SPC

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 6 May 2015 SPC

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 SPC

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 28 May 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 28 February 2014 SPC

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 6 February 2014 SPC

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 PIL

Reasons for updating

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

Updated on 18 June 2013 SPC

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 7 February 2013 SPC

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 3 October 2012 SPC

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 PIL

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 SPC

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 9 July 2012 SPC

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 PIL

Reasons for updating

  • New PIL for new product