Nplate vial *

  • Company:

    Amgen 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.

Updated on 28 January 2021

File name

en_nplate_approved_SPC_vial_v77 (IE and XI)_1611849460.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

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

Updated on 28 January 2021

File name

en_nplate_approved_pil_vial_v77 (IE + XI)_1611849299.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 January 2021

File name

en_nplate_approved_SPC_vial_v78_1610470421.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Updated on 02 June 2020

File name

en_nplate_approved_SPC_vial_psur18_1591086511.pdf

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)

EDM Updated on 01 April 2020

File name

Dosing Calaculator_1585755930.pdf

Reasons for updating

  • Replace File

EDM Updated on 19 October 2018

File name

Nplate Dose calculator_1535466808.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

The Nplate (romiplostim) dose calculator is provided to simplify the calculation of the correct dose and guide to the correct reconstitution and administration procedures. This is a formatted material with a pull out section - to request a printed copy of the dose calculator, please contact Amgen Medical Information on +44 (0) 1223 436441

File name

PIL_14431_924.pdf

Updated on 27 February 2018

File name

PIL_14431_924.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 27 February 2018

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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 6.4: update to storage conditions   
Section 10: date of revision to Jan 2018

Updated on 27 February 2018

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 07 February 2018

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 07 February 2018

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - 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
  • Change to section 6.3 - Shelf life
  • 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 8 - Marketing authorisation number(s)
  • 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

Sections: 1. NAME OF THE MEDICINAL PRODUCT & 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

• These sections have been updated to include a new vial size of 125 micrograms for paediatric use.

Section: 4.1 Therapeutic indications

Nplate powder for solution for injection has now been approved for use in patients one year of age or older. The indication statement now states:

• Nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

Section: 4.2 Posology and method of administration
Updated to reflect dosing in paediatric patients

Section: 4.4 Special warnings and precautions for use
Sub-section “Medication errors” updated to reflect paediatric population

Section: 4.8 Undesirable effects
• Updated to include adverse reactions observed in paediatric studies
• Information on bleeding events has been added to the sub-section “Description of selected adverse reactions”

Section: 5.1 Pharmacodynamic properties
Sub-section on paediatric patients updated

Section: 5.2 Pharmacokinetic properties
Information added on paediatric population

Section: 6.3 Shelf life
Information added about the product when diluted

Sections 6.5 Nature and contents of container, 6.6 Special precautions for disposal and other handling & 8.MARKETING AUTHORISATION NUMBER(S)
Updated to reflect the new vial size of 125 micrograms

Section: 10. DATE OF REVISION OF THE TEXT
Updated to January 2018

Updated on 09 May 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 27 April 2016

Reasons for updating

  • 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

Addition of table clarifying vial content

Updated on 27 April 2016

Reasons for updating

  • Change to date of revision
  • Change of special precautions for disposal

Updated on 27 January 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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 4.1

Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

Nplate may be consideredis indicated as second line treatment for adult non-splenectomised patients prior to splenectomy or where surgery is contra-indicated.


Section 4.4

Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients the second line this should include evaluation relative to splenectomy . The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).

Section 4.4

Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non-clinical toxicology studies (rat and monkey) but notas well as in ITP patients. Concurrent anaemia and leucocytosis (within a 4-week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy. Monitoring of these parameters should be considered in patients treated with romiplostim.

Section 4.8
Anaemia now a common adverse reaction (previously uncommon)

Section 5.1

New section titled “Results of studies compared to standard of care (SOC)”

Section 4.4

Updated on 27 January 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 30 July 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

clarification to pregnancy warning

Updated on 09 January 2015

Reasons for updating

  • Change to date of revision

Updated on 05 January 2015

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

Update PV reporting information from IMB to HPRA

Updated on 19 December 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 January 2014

Reasons for updating

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

Updated on 14 January 2014

Reasons for updating

  • 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 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 4.7 Effects on ability to drive and use machines

Information revised to state “Nplate has moderate influence on the ability to drive and use machines.”

Section 4.8 Undesirable effects

Upper respiratory tract infection added as a very common adverse reaction.

Gastroenteritis and palpitations added as common adverse reactions.

Erythromelalgia added as an uncommon adverse reaction.

5.1 Pharmacodynamic properties

 

The following text has been added “The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura)

 

10. Date of revision of the text

Updated to December 2013

Updated on 09 August 2013

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 Special warnings and precautions for use - update on information regarding Myelodysplastic Syndrome

Section 4.8 Undesirable effects – update on information regarding Myelodysplastic Syndrome and addition of Pharmacovigilance reporting.

Section 10 Date of revision of the text - revision of date

Updated on 09 August 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 27 March 2013

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 04 February 2013

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 10 - Date of revision of the text
  • Change to improve clarity and readability

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 - additional caution text

In Section 4.4 – Addition of a new sub section – Medication errors

In Section 4.6 – Revised text for pregnancy and breast feeding

In Section 4.8 – Undesirable effects – tabulated for ease of reading

In section 10 – Revision to date

Updated on 04 February 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 09 September 2011

Reasons for updating

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

Updated on 09 September 2011

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.  Special warnings and precautions for use & Section 4.8 Undesirable effects

Important safety information added on the risk of disease progression to Acute Myelogenous Leukaemia (AML) with Nplate® (romiplostim) use in patients with Myelodysplastic Syndrome (MDS).

 

Section 10 Date of the revision of the text

Date of revision updated.

Updated on 14 December 2010

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 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

Platelet count thresholds at which romiplostim dose should be reduced and interrupted have been lowered to >150x109/L for two consecutive weeks and >250x109/L, respectively in order to minimise the risk of thrombotic/thromboembolic events.

Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with TPO agonists.

 

Section 4.4

Portal venous thrombosis has been identified in patients with thrombocytopenia associated with hepatic insufficiency that were treated with thrombopoietin (TPO) agonists.

 

Section 4.8

Reclassification of adverse reactions and addition of an adverse event from spontaneous reporting

Section 10
Changed from 18-Oct-2010 to 26-Nov-2010

Updated on 10 December 2010

Reasons for updating

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

Updated on 03 November 2010

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, sub-section Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS).

Information regarding transient blast cell increases has been removed.

Updated on 18 February 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Sections 4.2 and 4.9, minor rearrangement of text and editorial changes

Updated on 15 February 2010

Reasons for updating

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

Updated on 05 October 2009

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 25 September 2009

Reasons for updating

  • New PIL for new product