Each vial contains:
factor (rhG-CSF)....300 microgram.
Filgrastim is a protein
produced by DNA genetic recombination
technology using E.Coli bacteria.
It stimulates the generation of neutrophils
within bone marrow, accelerates the recovery
of their count for the appropriate clinical
response.Compared with natural products,
its vitro biological activity and vivo are
"Filgrastim" is indicated
to reduce the incidence, severity and
duration of neutropenia and related clinical
sequelae such as fever and bacterial
infection susceptibility associated with
chemotherapy, so reduce the incidence of
patients receiving myelosupressive
chemotherapy or bone marrow transplant.
► Patients with acute myeloid leukemia
receiving indication or consolidation
► Cancer patients undergoing peripheral blood
progenitor cell collection, mobilization and
► Patients with severe neutropenia.
► Allergic reactions: Very rare (at rate less
than 1:4000) manifested, they usually occur
within the first 30 minutes after
administration, manifested as skin eruption,
Urticaria, face swelling, dyspnoea,
wheezing, tachycardia and hypotension , if
happened treatment with antihistaminic,
steroids, bronchodilators and/ or
► Rare splenic rupture or swelling: Monitor
spleen prior to or during therapy.
Avoid use in patients with adult respiratory
distress syndrome (ARDS), sickle cell disease
► Avoid simultaneous use with chemotherapy or
radiation therapy, it should be given 24-48
hours apart due to lack of well-controlled
Laboratory monitoring: Monitor
platelets counts prior to and during
chemotherapy or radiotherapy at regular
intervals (2-3 times/ week), bone marrow and
bone density examination.
► Avoid use in pediatric and geriatric
Use during pregnancy
and breast - feeding:
Used only if clearly needed
due to lack of well-controlled studies.
concomitant administration with drugs which
may potentiate neutrophils release, e.g.
► Avoid dilution with saline which may
precipitate the rhG-CSF.
rhG-CSF is contraindicated
for patients with hypersensitivity to the
active ingredients, other E.Coli derived
proteins or any other component of the drug.
The drug is
well-tolerated. Usually they are mild,
transient and disappear after withdrawal.
The major adverse reactions are bone and / or
musculoskeletal pain, rare skin eruption,
fever and shivering.
Dosage & route of
administration & duration:
To be used under medical
supervision: it is individualized based on
patient's clinical course and average
rhG-CSF injection should be administrated
once daily by I.V. or S.C. injection after
24-48 hours administration of chemotherapy or
► Cancer patients
5 microgram / kg body weight / day as a
single dose by S.C. injection or I.V.
infusion over 15-30 minutes.
► Cancer patients
receiving bone marrow
10 microgram/ kg body weight/ day as
I.V. infusion for 4 or 24 hours, or
continuous S.C. infusion for 24 hours.
patients undergoing peripheral blood
progenitor cell collection and therapy:
10 microgram / kg body weight / day either
as a bolus or continuous infusion at least 4
days before the first leukopheresis
procedure for 6-7 days, on days 5, 6 and 7.
Dose modification for patients who develop a
WBC count exceeding 100000 /mm3.
with severe chronic neutropenia:
Congenital: 6 microgram / kg body
weight/ day twice daily by S.C. injection.
Idiopathic: 5 microgram/ kg body weight/
day as single S.C. injection.
refrigerator at 2°C - 8°C
The vial can be kept at room temperature for
a maximum of 24 hours.
Do not reuse the vial and unused portion.
Keep out of reach of children.
Filgrastim Injection(Human granulocyte
colony stimulating factor)
Box of one vial.