Neulasta On Body Injector
*Company:
Amgen Ireland LtdStatus:
DiscontinuedLegal 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
Updated on 03 February 2023
File name
en_neulasta_approved_spc_v114 IE and XI.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2022
File name
en_neulasta_obi_approved_pil_euvar116_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 21 April 2021
File name
en_neulasta_approved_spc_v114 IE and XI.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.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.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.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
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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. |
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Section 4 Side Effects |
Rare side effects (may affect up to 1 in 1000 people):
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Date of revision of the text |
November 2019 |
Updated on 27 November 2019
File name
en_neulasta_approved_spc_PSURv20.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
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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. |
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Section 4.8 Undesirable Effects |
Stevens-Johnson syndrome added as a Rare ADR in Table of ADRs |
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Section 10 Date of revision of the text |
November 2019 |
Updated on 05 April 2019
File name
en_neulasta_approved_pil_obi_v107.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.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.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.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.
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
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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. |
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Section 4.8 Undesirable effects |
Addition of aortitis as a rare adverse reaction (vascular disorders) |
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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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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
- 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
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Section 3 Pharmaceutical form |
Addition of Solution for injection (injection) with on-body injector (Onpro kit) |
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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.
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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. |
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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 |
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Section 5.1 Pharmacodynamic properties |
Addition of information regarding PK study conducted in healthy volunteers for the OBI vs PFS |
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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. |
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Section 8 MA numbers |
EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector |
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Section 10 Date of revision of the text |
February 2018 |
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 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
4.8 - addition of glomerulonephritis, change to frequency of existing adverse reactions
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 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 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 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
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
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 10, the date of revision has changed
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 10 June 2011
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
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
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
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
- 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 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)