Composition:
Filgrastim SEDICO 300 microgramEach vial contains:
Recombinant human granulocyte-colony stimulating factor (rhG-CSF)....300 microgram.
Pharmacology:
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 consistent.


Indications:
"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 combined infection.
Cancer patients receiving myelosupressive chemotherapy or bone marrow transplant.
Patients with acute myeloid leukemia receiving indication or consolidation chemotherapy.
Cancer patients undergoing peripheral blood progenitor cell collection, mobilization and therapy(leukapheresis).
Patients with severe neutropenia.
Precautions:
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 adrenaline.
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 and osteoporosis.
Avoid simultaneous use with chemotherapy or radiation therapy, it should be given 24-48 hours apart due to lack of well-controlled studies.
Laboratory monitoring: Monitor RBC's and 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 patients.

Use during pregnancy and breast - feeding:
Used only if clearly needed due to lack of well-controlled studies.


Drug interactions:
Avoid concomitant administration with drugs which may potentiate neutrophils release, e.g. Lithium.
Avoid dilution with saline which may precipitate the rhG-CSF.

Contraindications:
rhG-CSF is contraindicated for patients with hypersensitivity to the active ingredients, other E.Coli derived proteins or any other component of the drug.


Adverse effects:
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 neutrophils count.
rhG-CSF injection should be administrated once daily by I.V. or S.C. injection after 24-48 hours administration of chemotherapy or radiotherapy.
Cancer patients receiving myelosupressive chemotherapy:
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 transplant:
10 microgram/ kg body weight/ day as I.V. infusion for 4 or 24 hours, or continuous S.C. infusion for 24 hours.
Cancer 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.
Patients with severe chronic neutropenia:
initial dose:
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.

Storage:
Keep in refrigerator at 2°C - 8°C
The vial can be kept at room temperature for a maximum of 24 hours.
Avoid shaking.
Do not reuse the vial and unused portion.
Keep out of reach of children.

Presentation:
Box of one vial.