Nyvepria

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

pegfilgrastim

Beschikbaar vanaf:

Pfizer Europe MA EEIG 

ATC-code:

L03AA13

INN (Algemene Internationale Benaming):

pegfilgrastim

Therapeutische categorie:

Immunostimulants,

Therapeutisch gebied:

Neutropenia

therapeutische indicaties:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Product samenvatting:

Revision: 5

Autorisatie-status:

Authorised

Autorisatie datum:

2020-11-18

Bijsluiter

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
NYVEPRIA 6 MG SOLUTION FOR INJECTION
pegfilgrastim
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nyvepria is and what it is used for
2.
What you need to know before you use Nyvepria
3.
How to use Nyvepria
4.
Possible side effects
5.
How to store Nyvepria
6.
Contents of the pack and other information
1.
WHAT NYVEPRIA IS AND WHAT IT IS USED FOR
Nyvepria contains the active substance pegfilgrastim. It is used in
patients treated with cytotoxic
chemotherapy (medicines that destroy rapidly growing cells) to reduce
the duration of neutropenia
(low neutrophil count, a type of white blood cell) and to help prevent
febrile neutropenia (low white
blood cell count with a fever). Nyvepria is for use in adults aged 18
years and over.
White blood cells are important for fighting off infection. If the
white blood cell count to fall too low,
due to your cytotoxic chemotherapy, your body may not be able to fight
off microorganisms and this
will increase the chances of an infection. Pegfilgrastim, is very
similar to a natural protein in the body
called granulocyte colony stimulating factor and it works by
encouraging your bone marrow to
produce more white blood cells that help your body fight off
infe

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Nyvepria 6 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL
solution for injection. The
concentration is 10 mg/mL based on protein only**.
*Produced in _Escherichia coli _cells by recombinant DNA technology
followed by conjugation with
polyethylene glycol (PEG).
**The concentration is 20 mg/mL if the PEG moiety is included.
The potency of this medicinal product should not be compared to the
potency of another pegylated or
non-pegylated protein of the same therapeutic class. For more
information, see section 5.1.
Excipients with known effect
Each pre-filled syringe contains 30 mg sorbitol (E420) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless, free from visible particles, solution for
injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in adult patients
treated with cytotoxic chemotherapy for malignancy (with the exception
of chronic myeloid leukaemia
and myelodysplastic syndromes).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nyvepria therapy should be initiated and supervised by physicians
experienced in oncology and/or
haematology.
Posology
One 6 mg dose (a single pre-filled syringe) of Nyvepria is recommended
for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
3
Special populations
_Renal impairment_
No dose change is recommended in patients with renal impairment,
including those with end-stage
renal disease.
_Paediatric population_
The safety and efficacy of pegfilgrastim in child