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108965009

Refrigerated Storage

NeupogenAmgen Ltd

Amgen Ltd
Neupogen
Solution for injection: 30 MU vials; 30 MU and 48 MU Singleject pre-filled syringes

Contact Amgen Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Accidental exposure to freezing temperatures does not adversely affect the stability of Neupogen.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

15 March 2021
London MI Service

Zarzio®Sandoz

Sandoz
Zarzio®
30 MU/0.5 ml and 48 MU/0.5 ml solution for injection or infusion in pre-filled syringes

In the event of an inadvertent temperature excursion the following data may be used:
Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 72 hours. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Accidental exposure to freezing temperatures does not adversely affect the stability of filgrastim.
The manufacturers cannot provide any further information on stability data or storage condition deviations.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Storage at ambient temperature: not provided by manufacturer.

See above
See above

Keep the pre-filled syringe in the outer carton in order to protect from light.

28 September 2020
London Medicines Information Services

NivestimHospira UK Ltd (Now part of Pfizer)

Hospira UK Ltd (Now part of Pfizer)
Nivestim
Pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:
Within its shelf-life and for the purpose of ambulatory use, the product may be removed from the refrigerator and stored at room temperature (not above 25°C) for one single period of up to 15 days. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 15 days as above
No - as stated above

Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim. The frozen pre-filled syringes can be thawed and then refrigerated for future use. If exposure has been greater than 24 hours or frozen more than once, then Nivestim should NOT be used.

5 May 2020
London MI Service

Lactation Safety Information

Unglycosylated recombinant human granulocyte-colony stimulating factor; rhG-CSF

Unglycosylated recombinant human granulocyte-colony stimulating factor; rhG-CSF
Yes
Limited published evidence of safety
Low levels anticipated in milk due to the drug's properties which are unlikley to be absorbed from the infants GI tract
Used in full-term neonates from birth
G-CSF is a normal component of breast milk
16 September 2019

New Medicines

GrastofilNeutropenia

Information

Grastofil
Biosimilar
LPC Pharmaceticals Ltd
Apotex

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Pre-registration (Filed)
01. Feb 15: Apotex Inc. announces FDA acceptance for filing of Filgrastim (Grastofil) via the US FDA Biosimilar Price Competition and Innovation Act (BPCIA) [1].
02. Filed in EU in 2013 [3]
03. Approved in the EU Oct 13 [4]

Category

Immunostimulating medicinal product (L03AA02) which regulates the production and release of functional neutrophils from the bone marrow
The incidence of drug-induced neutropenia is one case per million persons per year. The exact frequency of agranulocytosis is unknown; the estimated frequency is 1.0-3.4 cases per million population per year [2]
Neutropenia
Intravenous