Neupogen Singleject 48 MU (0.96 mg/ml)

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Neupogen Singleject 48 MU (0.96 mg/ml)

Name:
Neupogen Singleject 48 MU (0.96 mg/ml)
Company:
Amgen Ltd
Active Ingredients:
Filgrastim
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/19

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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 22 May 2019 PIL

Reasons for updating

Change to section 2 - what you need to know - contraindications
Change to section 4 - possible side effects
Change to section 6 - date of revision

Updated on 22 May 2019 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
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

Section 4.4 Special Warnings and Precautions for use

~~Patients with rare hereditary problems of fructose intolerance should not take this medicine.~~ Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.

Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). Medicines (containing sorbitol/fructose) given intravenously may be life-threatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.

A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.

Neupogen contains less than 1 mmol (23 mg) sodium per 0.6 mg/ml, ~~i.e~~ that . is to say essentially‘sodium free’.

Section 4.6 Fertility, pregnancy and lactation

Removal of the following in both the pregnancy and breast-feeding sub headings:

~~Women who become pregnant during Neupogen treatment are encouraged to enrol in Amgen’s Pregnancy Surveillance Programme. Contact details are provided at the end of the Package Leaflet.~~

Section 10 Date of revision of the text

March 2019

Updated on 6 February 2019 SmPC

Reasons for updating

Change to section 9 - Date of first authorisation/renewal of the 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

The following is the changes to the SmPC:

- Section 9 Date of First Authorisation/Renewal of the Authorisation - Date of latest renewal: 21 December 2018

- Section 10 Date of revision of the text - 21 December 2018

Updated on 14 August 2018 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - manufacturer
Change to section 6 - date of revision

Updated on 14 August 2018 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

In section 4.4 special warnings and precautions for use - a new section for aortitis has been added
In section 4.8 undesirable effects - addition of aortitis as a rare adverse reaction (vascular disorder)
In section 10 date of revision - the date of revision has been amended to 09 August 2018

Updated on 3 August 2018

Updated on 15 March 2018 PIL

Reasons for updating

New PIL for new product

Updated on 15 March 2018 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 March 2018 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.7 - Effects on ability to drive and use machines
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	Addition of subheadings for clarity; addition of heading for thrombocytopenia
Section 4.7 Effects on ability to drive and use machines	Reworded to include minor influence from dizziness
Section 4.8 Undesirable effects	ADR tables amalgamated for all indications. Revision to reflect updated frequencies New common event of dizziness
Section 10 Date of revision of the text	March 2018

Updated on 15 March 2018 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - date of revision

Updated on 24 April 2017 PIL

Reasons for updating

Change to section 6 - manufacturer

Updated on 19 October 2015 PIL

Reasons for updating

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

Updated on 19 October 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 - Addition of new section entitled "Glomerulonephritis"
Section 4.8 - Addition of glomerulonephitis to adverse reaction tables, change in frequency of "pain" in cancer patients (uncommon to very common)

Updated on 15 June 2015 SmPC

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

Correction to date of revision

Updated on 2 March 2015 PIL

Reasons for updating

Change to date of revision
Change to improve clarity and readability

Updated on 28 January 2015 PIL

Reasons for updating

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

Updated on 27 January 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 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

4.4 - Addition of text on hypersensitivity/immunogenicity; addition of sickle cell trait to section on sickle cell disease
4.8 - Addition of sickle cell crisis as an uncommon event to tables for PBPC mobilisation in normal donors, SCN patients and HIV patients
6.4 - Addition of instruction to keep in container to protect from light

Updated on 9 December 2014 PIL

Reasons for updating

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

Updated on 9 December 2014 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 6.5 - Nature and contents of container
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 information on the needle cover

Updated on 19 November 2014 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration
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

Editorial revision to posology information for clarity and consistency across indications

Updated on 3 October 2014 PIL

Reasons for updating

Change to information about pregnancy or lactation
Change to date of revision
Addition of information on reporting a side effect.

Updated on 3 October 2014 SmPC

Reasons for updating

Change to section 4.6 - Pregnancy and lactation
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

Update to information on pregnancy and breast feeding based on new preclinical data

Updated on 4 February 2014 PIL

Reasons for updating

Change to warnings or special precautions for use
Change to side-effects
Change to date of revision
Change to dosage and administration

Updated on 4 February 2014 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 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

In patients treated with myeloablative therapy followed by bone marrow transplantation

Revision of text to now state that “The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.”

4.4 Special warnings and precautions for use

Special precautions in cancer patients

· Addition of information regarding splenomegaly and splenic rupture

Special precautions in normal donors undergoing PBPC mobilisation

· Addition of the following information “Thrombocytopenia has been reported very commonly in patients receiving Neupogen. Platelet counts should therefore be monitored closely.”

Special precautions in SCN patients

· Addition of the following information “Thrombocytopenia has been reported commonly in patients receiving Neupogen.”

· Addition of information regarding splenomegaly and splenic rupture

Special precautions in patients with HIV infection

· Addition of information regarding splenomegaly and splenic rupture

4.8 Undesirable effects

Cancer patients

· Addition of splenic rupture as uncommon (≥ 1/1000 to < 1/100) adverse reaction

PBPC mobilisation in normal donors

· Addition of splenic rupture as uncommon (≥ 1/1000 to < 1/100) adverse reaction

SCN patients

· Addition of splenic rupture as a common (≥ 1/100 to < 1/10) adverse reaction

Additional information regarding splenomegaly and splenic rupture has been added under the sub-section “Description of selected adverse reactions” for all indications.

Information on where to report adverse reactions has been added

10. DATE OF REVISION OF THE TEXT

Date changed to January 2014

Updated on 30 August 2013 PIL

Reasons for updating

Change to side-effects
Change to date of revision

Updated on 30 August 2013 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 Special warnings and precautions for use

The symptoms of capillary leak are described. Advice is also provided on monitoring and giving patients treatment.

Section 4.8 Undesirable effects

Capillary leak syndrome added as a post-marketing potentially life-threatening adverse drug reaction in cancer patients

Section 10 Date of revision of the text

Changed to 21 Aug 2013

Updated on 19 July 2013 PIL

Reasons for updating

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

Updated on 19 July 2013 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 Special warnings and precautions for use

Special precautions in normal donors undergoing PBPC mobilisation:

· Text relating to the long term safety follow-up of normal donors has been deleted.

· To align with section 4.8 of the SmPC the frequency of splenic rupture has been changed from very rare to common.

· To align with section 4.8 of the SmPC dyspnoea has been assigned a frequency of common and the frequency of pulmonary events has been changed from very rare to uncommon.

Special precautions in SCN patients:

· To align with section 4.8 of the SmPC haematuria has been assigned a frequency of common.

Section 4.8 Undesirable effects

The Undesirable Effects section (section 4.8) of the SmPC has been revised according to the SmPC guideline (September 2009 version) for the following indications:

· PBPC mobilisation in normal donors

· SCN patients

· Patients with HIV

Section 10 Date of revision of the text

Date changed to 4 July 2013

Updated on 24 May 2013 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects
Change to section 10 - Date of revision of the text
Change to section 4.4 - Special warnings and precautions for use

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
Inclusion of information regarding vascular disorders

Section 4.8 Undesirable effects
Focusing on the chemotherapy induced neutropenia indication the Undesirable Effects section of the SmPC has been revised according to the SmPC guideline, September 2009 version and where necessary consequential changes have been made to the Special Warnings and Precautions for Use section of the SmPC.

Addition of a new sub-section

Paediatric SCN patients.

Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with Neupogen. The frequency is estimated as ‘common’ from clinical trial data.

Section 10 DATE OF REVISION OF THE TEXT
Changed to 17 April 2013

Minor administrative changes and corrections throughout the SmPC have also been made to ensure compliance with the latest Quality Review of Documents template (QRD template version 8.0).

Updated on 24 May 2013 PIL

Reasons for updating

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

Updated on 5 May 2011 PIL

Reasons for updating

Change to date of revision

Updated on 14 April 2011 PIL

Reasons for updating

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

Updated on 14 April 2011 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

The following changes have been made to the Summary of Product Characteristics

· Deletion of the statement in section 4.3 (Contraindications) “NEUPOGEN should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens“.

· Relocation of the statement “NEUPOGEN should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics“ that was in section 4.3 (Contraindications) to section 4.4 (Special Warnings and Precautions for Use) and to amend the statement.

· Deletion of the statement ‘If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing NEUPOGEN should be carefully weighed; NEUPOGEN should be discontinued if MDS or leukaemia occur’ from section 4.4, sub-section Transformation to leukaemia or myelodysplastic syndrome.
· Update to section 10 (date of revision of the text) to 4 April 2011

Updated on 23 July 2010 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 4.8 - Undesirable effects
Change to section 6.1 - List of excipients
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 - Updated to include information regarding the excipients sodium and sorbitol.

Section 4.4
Updated to include information regarding the excipients sodium and sorbitol.

Safety related terms have been amended in accordance to MedRA standard terms.
Information to record the trade name of the administered product has been included.

Section 4.8 – Text has been revised in accordance to MedRA standard terms and a subsection ‘Post-marketing experience’ under the frequency category ‘unknown’ has been introduced.

Section 6.1 now lists the E number for sorbitol (E420).

Section 10 - The date of revision of text has been updated.

Updated on 21 July 2010 SmPC

Reasons for updating

New individual SPC (was previously included in combined SPC)

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