Elaprase 2mg/ml concentrate for solution for infusion

  • Name:

    Elaprase 2mg/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Idursulfase

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/06/20

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Summary of Product Characteristics last updated on medicines.ie: 8/6/2020
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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Company Products

Medicine NameActive Ingredients
Medicine Name Elaprase 2mg/ml concentrate for solution for infusion Active Ingredients Idursulfase
Medicine Name Replagal 1 mg/ml concentrate for solution for infusion Active Ingredients Agalsidase alfa
Medicine Name VPRIV 400 Units powder for solution for infusion Active Ingredients Velaglucerase Alfa
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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 8 June 2020 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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

4.8 Undesirable effects

Amended text:

Ireland:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

4.9 Overdose

Amended text

There is no experience with overdoses of Elaprase.

There is limited information regarding overdose with Elaprase. Evidence suggests that some patients may experience an anaphylactoid reaction due to overdose (see sections 4.3 and 4.4).

10. DATE OF REVISION OF THE TEXT

28 May 2020

Updated on 8 June 2020 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

3. How to use Elaprase

Updated text:

If you use more Elaprase than you should

There is no experience with overdoses of this medicine.

Consult your doctor if you have an overdose of this medication.

Date of Revision of the Text: May 2020

Updated on 27 March 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 28 November 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 28 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 August 2018 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 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 section 4.8

Summary of the safety profile: Wheezing, dyspnea, vomiting, abdominal pain, nausea and chest pain added

Table 1
Frequency of hypertension, dyspepsia and infusion site swelling changed from very common to common
Frequency of Erythema changed from common to very common.
Frequency of tachypnea changed from common to uncommon

Yellow card reporting

''or search for MHRA Yellow Card in the Google Play or Apple App Store''

Updated on 31 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 January 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 September 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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

Addition of information on Sodium content. Other minor edits resulting from the MA renewal assessment.

Updated on 15 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 September 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to how the medicine works

Updated on 15 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 28 July 2016 SmPC

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

Change to MAH address

Updated on 27 July 2016 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 15 April 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 2 to 3 years.

Updated on 3 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company



Inclusion of a recommendation to deliver the total volume of infusion using a 0.2 µm in line filter, and addition that Elaprase should not be infused with other products in the infusion tubing as already indicated in the PIL.

Updated on 2 November 2015 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 22 October 2015 PIL

Reasons for updating

  • Change of manufacturer

Updated on 24 September 2015 SmPC

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

Change to date of first authorisation and to date of latest renewal

Updated on 26 June 2015 SmPC

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

Minor update to Section 5.1

Updated on 19 June 2015 PIL

Reasons for updating

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

Updated on 13 November 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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



4.3 Contraindications: revision of hypersensitivity language

4.4 Special Warnings and Precautions for Use: added also language referring to hypersensitivity information in 4.3
Date of revision

Updated on 7 October 2013 SmPC

Reasons for updating

  • 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

rewording to various sections

section 4.8 how to report a side effect added

Updated on 7 October 2013 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 22 February 2013 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 4.8 - Undesirable effects
  • 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

Section 4.2 posology and administration  -

Statement removed – “The safety and efficacy of Elaprase in children under the age of 5 years has not yet been established”

  

Section 4.4 Special warnings and precautions for use –

Statement removed - “Patients who develop IgM or IgG antibodies are at a higher risk of infusion reactions and other adverse reactions.”

Warning added regarding patients with the complete deletion/large rearrangement genotype

 

Section 4.8 undesirable effects –

‘vomiting’ added to adverse reaction list.  Immunogenicity data from studies added.

 

Section 5.1 pharmacodynamic properties –

Immunogenticity data from clinical studies added.  

Data from study in children added

 

Section 5.2 pharmacokinetic properties –

Data about pharmacokinetic properties as a function of age and of body weight added.

Updated on 18 February 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 6 July 2012 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 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 – slight rewording

Section 4.2 – slight rewording

Section 4.4 – slight rewording

Section 4.6 – slight rewording

Section 4.8 – slight rewording.

Section 4.8 -  sentence added  “ Paediatric population  Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.”

Section 10 – Date of revision of text changed to “10 January 2012”

Updated on 28 June 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 13 August 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to name of manufacturer

Updated on 22 June 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2 the following text has been added:

Infusion of Elaprase at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional.

Section 4.6 reworded as follows:

Elaprase is not indicated for use in women of child bearing potential. No reproductive studies in female animals have been performed.

No effects on male fertility were seen in reproductive studies in male rats. 

 

There are no data from the use of idursulfase in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Section 5.3).  As a precautionary measure, it is preferable to avoid the use of Elaprase during pregnancy.

                                      

It is not known whether idursulfase is excreted in human breast milk.  Available data in animals have shown excretion of idursulfase in milk (see Section 5.3).  A risk to the suckling child cannot be excluded.  A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Elaprase should be made taking into account the benefit of breast-feeding to the child and the benefit of Elaprase therapy to the woman.


Section 4.7 the following sentence has been deleted:

Excretion of idursulfase in milk has not been studied.

 

Section 4.8 the table of adverse reactions has been revised in full.

Section 5.1 the following text has been added:

All patients received weekly idursulfase up to 3.2 years in an extension to this study (TKT024EXT).

 

Among patients who were originally randomised to weekly idursulfase in TKT024, mean maximum improvement in distance walked during six minutes occurred at Month 20 and mean percent predicted FVC peaked at Month 16.

 

Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m and from 6.4% to 11.7% (maximum at Month 20).  At most time points tested, patients who were from the original TKT024 weekly treatment group improved their walking distance to a greater extent that patients in the other 2 treatment groups.

 

Among all patients, mean % predicted FVC was significantly increased at Month 16, although by Month 36, it was similar to the baseline.  Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement.

 

Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for each of the prior TKT024 treatment groups.  Mean changes from 0.07L to 0.31L and percent ranged from 6.3% to 25.1% (maximum at Month 30).  The mean and percent changes from treatment baseline were greatest in the group of patients from the TKT024 study who had received the weekly dosing, across all time points.

 

At their final visit 21/31 patients in the TKT024 Weekly group, 24/32 in the TKT024 EOW group and 18/31 patients in the TKT024 placebo group had final normalised urine GAG levels that were below the upper limit of normal.  Changes in urinary GAG levels were the earliest signs of clinical improvement with idursulfase treatment and the greatest decreases in urinary GAG were seen within the first 4 months of treatment in all treatment groups; changes from Month 4 to 36 were small.  The higher the urinary GAG levels at baseline, the greater the magnitude of decreases in urinary GAG with idursulfase treatment.

 

The decreases in liver and spleen volumes observed at the end of study TKT024 (week 53) were maintained  during the extension study (TKT024EXT) in all patients regardless of the prior treatment they had been assigned.  Liver volume normalised by Month 24 for 73% (52 out of 71) of patients with hepatomegaly at baseline.  In addition, mean liver volume decreased to a near maximum extent by Month 8 in all patients previously treated, with a slight increase observed at Month 36.  The decreases in mean liver volume were seen regardless of age, disease severity, antibody status or neutralising antibody status.  Spleen volume normalised by Months 12 and 24 for 9.7% of patients in the TKT024 Weekly group with splenomegaly.

 

Mean cardiac LVMI remained stable over 36 months of idursulfase treatment within each TKT024 treatment group.


Section 5.3 revised as follows:

Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity, toxicity to reproduction and development and to male fertility. No reproductive toxicity studies in female animals have been performed.  

 

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.

 

Animal studies have shown excretion of idursulfase in breast milk.

Section 10 - Date amended for the revision of the text. 

Updated on 1 June 2009 SmPC

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

Change in contact details of MAH

Updated on 28 May 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 August 2008 SmPC

Reasons for updating

  • New SPC for new product

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