Indication:
Chemotherapy induced neutropenia
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Filgrastim Injection Ant-Cancer September 1993
Proprietary Name- ZARXIO*
Established Name- Filgrastim-sndz
Applicant- Sandoz Inc.
Indication- Biosimilar to U.S. licensed neupogen for the five indications
for which US-licensed Neupogen is approved.
The formulation of ZARXIO differs from that of US-licensed
Neupogen in one inactive component
Approval Date- 3/6/2015
Approved by U.S.FDA as on 31-08-2015 (Ref- FDA approved List- 2015)
Adverse Reaction:
Musculoskeletal pain Bone pain Splenic enlargement Hepatomegaly Thrombocytopenia Anaemia Epistaxis Headache, Vomiting Diarrhea Urinary abnormalites Osteoporosis Exacerbation of rheumatoid arthiritis Transcient decrease in blood glucose Raised uric acid levels
Contra-Indications:
Myeloid malignancies not to be used within 24 hrs of cytotoxic chemotherapy due to sensitivity of rapidly dividing myeloid cells Severe congenital neutropenia Special precautions Premalignant or malignant myeloid conditions Sickle cell disease Osteoporic bone marrow disease Withdraw treatment if there are signs of pulmonary infiltrates Fluid retention or heart failure Monitor CBC and platelet count during therapy Monior bone density in patients with osteoporosis( long term treatment)
Dosages/ Overdosage Etc:
Date of Approval 1993
Indication
Chemotherapy induced neutropenia
Dosage-
Starting dose is 5mmcg/kg/day given as single daily injection by SC bolus inj , by short IV infusion ( 5 to 30 minutes ) or by as continous iv or sc infusion
Obtain CBC and platelet count before intituting therapy, monitor twice weekly during therapy
Manufacturer Details