Fulphila

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pegfilgrastim

Available from:

Biosimilar Collaborations Ireland Limited

ATC code:

L03AA13

INN (International Name):

pegfilgrastim

Therapeutic group:

Immunostimulants,

Therapeutic area:

Neutropenia

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).

Product summary:

Revision: 12

Authorization status:

Authorised

Authorization date:

2018-11-20

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
FULPHILA 6 MG SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE
pegfilgrastim
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 Fulphila is and what it is used for
2.
What you need to know before you use Fulphila
3.
How to use Fulphila
4.
Possible side effects
5.
How to store Fulphila
6.
Contents of the pack and other information
1.
WHAT FULPHILA IS AND WHAT IT IS USED FOR
Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is
a protein produced by
biotechnology in bacteria called
_E. coli_
. It belongs to a group of proteins called cytokines, and is very
similar to a natural protein (granulocyte-colony stimulating factor)
produced by your own body.
Fulphila is used to reduce the duration of neutropenia (low white
blood cell count) and the occurrence
of febrile neutropenia (low white blood cell count with a fever) which
can be caused by the use of
cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
White blood cells are
important as they help your body fight infection. These cells are very
sensitive to the effects of
chemotherapy which can cause the number of these cells in your body to
decrease. If white blood cells
fall to a low level there may not be enough left in the body to fight
bacteria and you may have an
increased risk of infection.
Your doctor has given you Fulphila to encourage your bone marrow (part
of the bone which makes
blood cells) to produce more white blood cells that he

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fulphila 6 mg solution for injection in pre-filled syringe
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 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
Excipient 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 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
Pegfilgrastim 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 pegfilgrastim is
recommended for each chemotherapy
cycle, given at least 24 hours after cytotoxic chemotherapy.
Special populations
_Patients with renal impairment _
No dose change is recommended in patients with renal impairment,
including those with end stage
renal disease.
3
_Paediatric population _
The safety and efficacy of pegfilgrastim in children has not yet been
established. Currently available
data are described in sections 4.8, 5.1 and 5.2 but no recommendation
on a posology can be made.
Method of administration
Fulphila is injected subcutaneously. The injections should be given