Evoltra 1 mg/ml concentrate for solution for infusion

  • Name:

    Evoltra 1 mg/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Clofarabine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/03/20

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Summary of Product Characteristics last updated on medicines.ie: 14/1/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

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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 17 March 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 17 June 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 14 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 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 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 14 December 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 14 December 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

zTo update SmPC section 4.4 with new headings to improve the readability in order to better find the information

Updated on 7 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 October 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 4 October 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 30 September 2016 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 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

PSUSA-00000805-201512 PSUR

Updated on 9 March 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 17 February 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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)

Free text change information supplied by the pharmaceutical company

.

Updated on 19 October 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 29 September 2015 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 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 with the following:

·         Renal and hepatic function prior to, during active treatment and following therapy.  Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.


Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).


Section 4.8: Hepato-biliary disorders updated to include 'hepatic failure.  Uncommon: Hepatitis.'

Updated on 29 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 7 May 2014 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

Type IIC Bulk - CCDS v5 and 6 to update SPC Sections 4.4 and 4.8 re: haemorrhaging (v42).

Updated on 8 April 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to how the medicine works
  • Change to dosage and administration

Updated on 3 December 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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)

Free text change information supplied by the pharmaceutical company

Type IIC Bulk - CCDS SPC update including QRD and Croatia v039.

Updated on 9 January 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 December 2011 SmPC

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

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

Free text change information supplied by the pharmaceutical company

In section 

4.2  (Posology and method of administration), paragraph 8  new text added
In section 4.4 (Special warnings and precautions for use) new text added
in section 5.2 (Pharmacokinetic properties) new text added

Updated on 15 December 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 April 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 18 April 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Changes made to the following sections:

 

3.       PHARMACEUTICAL form

Deletion of “(sterile concentrate)”

 

4.2     Posology and method of administration

Addition of heading “Posology”

Change to sub headers “Adult population” and “Paediatric population

First sentence for “Method of administration” 

changed from –

Method of administration: Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration (see section 6.6).”

To –

“Method of administration” – sub header

“For instructions on dilution of the medicinal product before administration, see section 6.6”

 

4.6         Fertility, pregnancy and lactation

Addition of following paragraph section “Contraception in males and females”

“Females of childbearing potential and sexually active males must use effective methods of contraception during treatment.” 

 

4.8         Undesirable effects

Addition of the highlighted sections in this paragraph – “The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m2 daily x 5.  Adverse reactions are listed by system organ class and frequency (very common (³1/10); common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100; rare (³1/10,000 to <1/1,000) and very rare (<1/10,000)) in the table below. Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Sections of the table have been moved around.

 

5.1     Pharmacodynamic properties

This paragraph has been moved to the end of this section after the table - “This medicinal product has been authorised under “Exceptional Circumstances”.  This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.  The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.”

 

6.6     Special precautions for disposal and other handling

Addition to “and other handling” in the sub header

Addition of this sentence at the end of this section “Any unused product or waste material should be disposed of in accordance with local requirements.”

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of latest renewal added.

 

10.     DATE OF REVISION OF THE TEXT

Updated on 16 April 2010 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 16 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie