VPRIV 400 Units powder for solution for infusion *

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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.

EDM Updated on 19 April 2021

File name

Safety Information and Emergency plan - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Home infusion guide - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Home Administration - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Home admin and dosing guide - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Checklist to determine eligibility of patients prior to initiation of home infusion - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Infusion Diary - Jun 2016_1618849016.pdf

Reasons for updating

  • Add New Doc

Updated on 16 March 2021

File name

VPRIV SmPC IE - TII-0047 CCDS v10 - June 2020 - Clean_1615916651.pdf

Reasons for updating

  • New individual SPC (was previously included in combined SPC)
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

4.2 Posology and method of administration

Method of administration

For intravenous infusion use only.

To be administered as a 60-minute intravenous infusion.

Must be administered through a 0.2 or 0.22 µm filter.

4.4 Special warnings and precautions

Infusion-related reactions

An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion. Infusion‑related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies. An IRR often appears as a hypersensitivity reaction. The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache. Symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience. Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred, or vomiting. In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.

Immunogenicity

Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa. To further evaluate the relationship, in cases of severe infusion‑related reactions and in cases of lack or loss of effect, patients should be tested for the presence of antibodies and the results reported to the company.

In the clinical studies for Marketing Authorisation registration enabling studies one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa. In this one event, the antibodies were determined to be neutralising in an in vitro assay.

No patients developed IgE antibodies to velaglucerase alfa.

No infusion‑related reactions were reported.

Post-marketing phase

During a post marketing extension study, one patient developed IgG antibodies to VPRIV. In addition, a few events of positive neutralising antibodies and lack of effect were reported post marketing.

for this patient. No patients developed IgE antibodies to velaglucerase alfa.

5.1 Pharmacodynamic properties

Studies 032, 039 corrections made to age of patients – changed from 2 years and older to 4 years and older

6.6 Special precautions for disposal and other handling

VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only. It is for single use only and is administered through a 0.2 or 0.22 µm filter.

10 Date of revision of the text

28 January 2021

Updated on 16 March 2021

File name

VPRIV PIL IE - TII-0047 CCDS v10 - June 2020 - Clean (003)_1615916387.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 06 January 2021

File name

VPRIV SmPC IE - TIB-040 June 2019 + Renewal 23 July 2020 - Clean_1609953362.pdf

Reasons for updating

  • Change from joint to individual SPCs

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

Updated on 04 August 2020

File name

VPRIV SmPC UK-IE - TIB-040 June 2019 + Renewal 23 July 2020 - Clean_1596548356.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to MA holder contact details
  • Updated inline with QRD template and/or excipient guideline

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

Updated on 04 August 2020

File name

VPRIV PIL UK-IE - TIB-040 June 2019 + Renewal July 2020 - Clean_1596548200.pdf

Reasons for updating

  • 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 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 21 June 2019

File name

UK_IE - SmPC - VPRIV - 04_18_1561106684.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 09 May 2018

File name

UK_IE_-_SmPC_-_VPRIV_-_04_18.docx

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 2018

File name

UK_IE_-_SmPC_-_VPRIV_-_04_18.docx

Reasons for updating

  • 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)

Updated on 26 April 2018

File name

UK_IE - PIL - VPRIV - 03_18.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 May 2017

File name

PIL_15606_679.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 May 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 October 2016

Reasons for updating

  • New SPC for new product

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

Updated on 26 October 2016

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

Update to introduce paediatric data to Sect 5.1 of the SmPC following completion of activities associated with the paediatric investigation plan.

This revision of the VPRIV SmPC results from a Rectificative EC Decision, hence the October 2016 approval is backdated to Aug 2016.

Aug 2016 is the official date of revision on the SmPC. 

 

Updated on 07 December 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update of the SmPC section 4.4 with information on hypersensitivity reactions including symptoms consistent with anaphylaxis; and of SmPC section 4.8 to include 3 new adverse drug reactions (ADRs): chest discomfort, dyspnoea, and pruritus with the frequency common as symptoms of infusion-related reactions (IRRs) occurring in post-marketing experience and to precise the types of hypersensitivity reactions based on the review of post-marketing safety data. A minor consequential change is introduced in section 4.2 of the SmPC.

Updated on 01 December 2015

Reasons for updating

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

Updated on 22 October 2015

Reasons for updating

  • Change of manufacturer

Updated on 03 July 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 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 to noted sections following approval of the EU 5 year renewal

Updated on 26 June 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to dosage and administration

Updated on 29 January 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.6 Pregnancy

Statement "There are no data from the use of velaglucerase alfa in pregnant women." changed to "There are no or limited amount of data of data from the use of velaglucerase alfa in pregnant women."

Section 4.8 Undesirable Effects.

Statement about reporting of suspected adverse events added.

 

Section 5.1 Pharmacodynamic properties

Clinical trial data added - details of extension study 044.

Updated on 22 January 2014

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 13 May 2013

Reasons for updating

  • 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

5.1 Pharmacodynamic properties

 

Further data included from study 025 regarding bone marrow burden scores and bone mineral density Z-scores.

Updated on 13 May 2013

Reasons for updating

  • Change to date of revision

Updated on 28 January 2013

Reasons for updating

  • 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

Change to date of text,  to match corresponding date on current PIL, since removal of 200U

No other change to SmPC text.

Updated on 24 January 2013

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 25 July 2012

Reasons for updating

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

Section  4.2

Elderly ( 65 years old)

Four of the 94 patients (5%) who received velaglucerase alfa during clinical studies were age 65 years or older. The limited data do not indicate a need for a dose adjustment in this age group.”

Changed to

 “Elderly (≥65 years old)

Elderly patients may be treated within the same dose range (15 to 60 U/kg) as other adult patients. See section 5.1.”

 

 

Section 4.8

 

Sentence added

 

Elderly population (≥65yrs)

The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.”

 

Section 5.1

 

Paragraph added

 

“Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase, 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to VPRIV). Patients transferring from imiglucerase were administered VPRIV infusions every other week at the same number of units as imiglucerase within the range of 15 to 60 U/kg. Patients transferring from a dose of <15 U/kg imiglucerase were administered 15 U/kg of VPRIV.

 

Patients previously treated with imiglucerase received a median of 8 VPRIV infusions with median duration of treatment of 15.1 weeks. The safety profile in these patients was similar to that observed in other clinical trials.  Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.

 

The mean haemoglobin concentration and platelet count of patients previously treated with imiglucerase were maintained throughout the study and remained within the reference intervals.”

Updated on 18 November 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

In section 6.5 Nature and contents of container - text for 5 and 25 vials has been added as follows:

Pack sizes of 1, 5 and 25 vials.

Not all pack sizes may be marketed.


In section 8 Marketing Authorisation Number(s), the following have been added:
EU/1/10/646/005
EU/1/10/646/006

In section 10 Date of Revision of the text - 03/11/2010 has been added.

Updated on 08 November 2010

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