Neulasta On Body Injector *

  • 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 21 April 2021

File name

en_neulasta_approved_spc_v114 IE and XI_1619017254.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 11 January 2021

File name

en_neulasta_approved_pil_obi_v113_1610389582.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 11 January 2021

File name

en_neulasta_approved_spc_v113_1610389430.pdf

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
  • Correction of spelling/typing errors

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

Updated on 27 November 2019

File name

en_neulasta_approved_pil_obi_PSURv20_1574869373.pdf

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

Free text change information supplied by the pharmaceutical company

Section 2 Warnings and Precautions

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4.

Section 4 Side Effects

Rare side effects (may affect up to 1 in 1000 people):

  • inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
  • bleeding from the lung (pulmonary haemorrhage).
  • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Neulasta if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Date of revision of the text

November 2019

Updated on 27 November 2019

File name

en_neulasta_approved_spc_PSURv20_1574869311.pdf

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

Stevens-Johnson syndrome

Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.

Section 4.8 Undesirable Effects

Stevens-Johnson syndrome added as a Rare ADR in Table of ADRs

Section 10 Date of revision of the text

November 2019

Updated on 05 April 2019

File name

en_neulasta_approved_pil_obi_v107_1554457827.pdf

Reasons for updating

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

Updated on 05 April 2019

File name

en_neulasta_approved_spc_v107_1554457802.pdf

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

  • In section 4.6 Fertility, pregnancy and lactation the following has been removed - Women who become pregnant during Neulasta treatment are encouraged to enrol in Amgen’s Pregnancy Surveillance Programme. Contact details are provided in section 6 of the Package leaflet.
  • In section 10 Date of revision of the text - Date revised to March 2019

Updated on 26 September 2018

File name

en_neulasta_approved_pil_v106_1537956828.pdf

Reasons for updating

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

Updated on 26 September 2018

File name

en_neulasta_approved_spc_v106_1537956772.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)

Free text change information supplied by the pharmaceutical company

In section 4.8 undesirable effects: Addition of haemoptysis as a uncommon adverse reactions (respiratory, thoracic and mediastinal disorders), Addition of pulmonary haemorrhage as a rare adverse reaction (vascular disorders).

In section 10 date of revision of the text: revision date amended to September 2018.

EDM Updated on 28 August 2018

File name

Neulasta OBI PAC_IE_FINAL_corrected.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

The Patient Alert Card contains information regarding the importance of actively monitoring the on body injector device, how to recognize a failure of the device to deliver the intended dose, and actions to take if patients have issues with the device or symptoms of infection, such as the need to immediately call a health care provider for a replacement dose. To request a copy of the patient alert card, please contact Amgen Medical Information on +44 (0) 1223 436441

File name

en_neulasta_approved_pil_v101.pdf

File name

en_neulasta_approved_pil_v101.pdf

Updated on 24 May 2018

File name

en_neulasta_approved_pil_v101.pdf

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 May 2018

File name

en_neulasta_approved_spc_v101.docx

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

New section:

Aortitis

Aortitis has been reported in patients receiving G-CSF such as pegfilgrastim. The symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers (e.g. creactive protein and white blood cell count) were raised. In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF. See section 4.8.

Section 4.8 Undesirable effects

Addition of aortitis as a rare adverse reaction (vascular disorders)

Section 10 Date of revision of the text

May 2018

Updated on 09 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 March 2018

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 6.4 - Special precautions for storage
  • 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

Section 3 Pharmaceutical form

Addition of Solution for injection (injection) with on-body injector (Onpro kit)

Section 4.2 Posology and method of administration

Special populations sections moved up within the section

Addition of information regarding method of administration of the OBI

 

Method of administration

Neulasta is injected subcutaneously via:

a pre-filled syringe for manual administration; or

a pre-filled syringe with on-body injector for automatic administration.

 

Neulasta 6 mg solution for injection in pre-filled syringe

The manually administered injections should be given into the thigh, abdomen or upper arm.

 

Neulasta 6 mg solution for injection in pre-filled syringe with on-body injector

The on-body injector must be filled using the co-packed pre-filled syringe. The on-body injector should be applied to intact, non-irritated skin on the back of the arm or abdomen. The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector. Approximately 27 hours after the on-body injector is applied to the patient’s skin, Neulasta will be delivered over approximately 45 minutes. Once filled, the on-body injector should be used for immediate application and can be applied on the same day as the administration of cytotoxic chemotherapy, as long as application is timed to ensure the on-body injector delivers Neulasta at least

24 hours after administration of cytotoxic chemotherapy.

The on-body injector must only be used with the co-packed pre-filled syringe. The co-packed prefilled syringe contains additional solution to compensate for residual liquid retained in the on-body injector after delivery. If the pre-filled syringe co-packed with the on-body injector is used for manually administering a subcutaneous injection, the patient will receive more than the recommended dose. If the pre-filled syringe for manual administration is used with the on-body injector, the patient may receive less than the recommended dose.

 

For instructions on handling of the medicinal product before administration, see section 6.6.

 

Section 4.4 Special warnings and precautions for use

Traceability heading moved to top of section

New heading for medication errors

                                                                                            

Medication error as a result of device failure

There is a risk of medication error, particularly a partial or missed dose of pegfilgrastim, in the event of a device failure or malfunction with the on-body injector. In the event of a partial or missed dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. The healthcare professional must ensure the patient

receives appropriate training about the on-body injector and understands that if they suspect a device failure or malfunction the patient must immediately inform a healthcare professional as they may need a replacement dose. Comprehensive instructions for use for healthcare professionals and patients are given in the package leaflet. The patient should also be given the Patient Alert Card.

Section 4.8 Undesirable effects

Addition of Application site reactions and Dermatitis contact, possibly indicating a hypersensitivity reaction to the adhesive, as common adverse reactions reported with the use of the on-body injector

Section 5.1 Pharmacodynamic properties

Addition of information regarding PK study conducted in healthy volunteers for the OBI vs PFS

Section 6 Pharmaceutical particulars

Addition of information regarding the OBI

The pre-filled syringe for use with the on-body injector may be exposed at room temperature for no longer than 36 hours prior to filling the on-body injector.

 

On-body injector, the fluid path is made from polypropylene, cyclic olefin copolymer, silicone rubber and fluorinated ethylene propylene (FEP), with a stainless steel 28 gauge needle. The on-body injector contains three silver oxide batteries and includes an adhesive patch made from non-woven polyester tape single coated with a polyacrylate adhesive.

 

Each pre-filled syringe for use with the on-body injector contains 0.64 mL of solution for injection.

 

Pack size of one pre-filled syringe in blistered packaging co-packed with an on-body injector.

 

The on-body injector must only be used with the Neulasta pre-filled syringe co-packed in the carton. The Neulasta pre-filled syringe for manual administration must not be used with the on-body injector.

Section 8 MA numbers

EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector

Section 10 Date of revision of the text

February 2018

Updated on 26 March 2018

File name

PIL_14998_414.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • 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 24 June 2015

Reasons for updating

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

Updated on 24 June 2015

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

4.4 - addition of new section titled glomerulonephritis
4.8 - addition of glomerulonephritis, change to frequency of existing adverse reactions

Updated on 22 August 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 – Qualitative and quantitative composition

The quantity of sorbitol in each pre-filled syringe has been corrected to now state 30 mg.  It was previously incorrectly stated as 6.0 mg.

Section 4.2 – Posology and method administration

This section has been updated to now state that “One 6 mg dose (a single pre-filled syringe) of Neulasta is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.”

 

Addition of a new sub section “Method of administration”

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

 

This section has been updated to now state that Neulasta should be administered at least 24 hours after administration of cytotoxic chemotherapy.

Section 10 – Date of revision of the text

Updated to August 2014

Updated on 22 August 2014

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 19 June 2014

Reasons for updating

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

Updated on 19 June 2014

Reasons for updating

  • 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 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 Special warnings and precautions for use


Addition of;
• an updated precautionary statement relating to hypersensitivity
• a precaution statement relating to immunogenicity
• an association of the adverse event sickle cell crises in patients with ‘sickle cell trait’

4.8 Undesirable effects

Updates to;
• subsection A to include isolated cases of sickle cell crisis in patients with sickle cell trait
• subsection B, tabulated summary of adverse reactions to move splenomegaly and splenic rupture to the correct MedDRA system organ class of blood and lymphatic disorders.


10. DATE OF REVISION OF THE TEXT

This section has been updated to May 2014

Updated on 19 December 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.9 - Overdose
  • 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

Throughout the SmPC

Minor changes have been made throughout the SmPC.

 

4.1 Therapeutic indications

Addition of the word “adult” to the indication

 

4.2 Posology and method of administration

This section has been updated to now state that “The safety and efficacy of Neulasta in children has not yet been established.”

 

4.6 Fertility, pregnancy and lactation

This section has been updated, and now states that:

 

“Neulasta is not recommended during pregnancy and in women of childbearing potential not using contraception.”

 

“There is insufficient information on the excretion of Neulasta/metabolites in human milk, a risk to the newborns/infants cannot be excluded.  A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neulasta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.”

 

Details added to this section regarding Amgen’s Pregnancy/Lactation Surveillance Programme

 

Addition of text regarding pegfilgrastim affect on fertility

 

4.8 Undesirable effects

Details on where to report suspected adverse reactions added.

 

4.9 Overdose

Additional information added to this section

 

5.3 Preclinical safety data

Additional information added to this section

 

10 Date of revision of the text

Date changed to 21 November 2013

Updated on 19 December 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 05 December 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 04 December 2013

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 Special warnings and preacautions for use
The following information has been added"In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the tradename of the administered product should be clearly recorded in the patient file."

Section10 Date of revision of the text
The date has changed to 15 November 2013

Updated on 30 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

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 25 July 2013

Updated on 30 August 2013

Reasons for updating

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

Updated on 06 March 2013

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 26 January 2012

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 November 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3, the shelf-life has been changed from 30 months to 3 years.
In section 10, the date of revision has changed

Updated on 10 June 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 10 June 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)

Updated to align with the changes made to section 4.8 of the SPC and addition of text regarding serious allergic reactions and WBC count

 

Section 4.8 (undesirable effects)
Updated to align with the SPC guideline and addition of the term “hypersensitivity” along with the frequency for anaphylactic reactions/ hypersensitivity reactions.

Section 10 (date of revision of the text)
Changed to 27 May 2011

Updated on 25 May 2011

Reasons for updating

  • New PIL for new product

Updated on 10 February 2010

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
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

New clinical data from a study in paediatric patients has led to the revision of the sections on Undesirable effects (section 4.8), pharmacodynamics (section 5.1) and pharmacokinetis (section 5.2).
Section 6.5 updated to include new presentation with automatic needle guard.

Updated on 14 July 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 - addition of renal impairment
Section 4.8 - addition of very rare undesirable effects
Section 5.2 - addition of data from open label study re; renal impairment

Updated on 01 November 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 24 August 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 24 August 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 28 February 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 23 February 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - 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

Section 4.4 - Special warnings and precautions for use

Addition of text re sickle cell crises.

Addition of text re the needle cover containing dry natural rubber which may cause allergic reactions.

Addition of text re bone imaging findings.

Section 4.8 Undesirable effects

Addition of text re rare events of cutaneous vasculitis and isolated cases of sickle cell crises.

Section 6.5 Nature and contents of container

Addition of needle cover containing dry natural rubber

Updated on 23 November 2005

Reasons for updating

  • 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

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

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 09 August 2004

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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)

Updated on 05 March 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 20 May 2003

Reasons for updating

  • New SPC for new product

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