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Rx Item-ZARXIO filgrastim-sndz 300 MCG PFS 10X0.5 ML BY SANDOZ

item No.:RX740567 740567 NDC No.  61314-0318-10 61314031810 61314-318-10 6131431810 UPC/GTIN No. 361314-318107 3-61314-31810-7 361314318107 MPN 44876 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,DistBRAND: ZARXIO  NDC: 61314-0304-10,61314030410 UPC: 3-61314-30410-0,361314304100 ASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-ZARXIO filgrastim-sndz 300 MCG PFS 10X0.5 ML BY SANDOZ

$3292.36$3041.52

Item No.: RX740567 740567 NDC No. 61314-0318-10 61314031810 61314-318-10 6131431810 UPC/GTIN No. 361314-318107 3-61314-31810-7 361314318107 MPN 44876 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx740567 ZARXIO 300 MCG PFS 10X0.5 ML Other Name Zarxio

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For: Neutropenia Associated with Chemotherapy Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to the reference product Neupogen, indicated for the treatment of neutropenia associated with chemotherapy. ZARXIO- filgrastim-sndz injection, solution
Sandoz Inc


INDICATIONS AND USAGE
1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
ZARXIO is indicated to decrease the incidence of infection� as manifested by febrile neutropenia� in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies ( 14.1)].
1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)].
1.3 Patients with Cancer Undergoing Bone Marrow Transplantation
ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae� e.g.� febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)].
1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)].
1.5 Patients with Severe Chronic Neutropenia
ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.� fever� infections� oropharyngeal ulcers) in symptomatic patients with congenital neutropenia� cyclic neutropenia� or idiopathic neutropenia [see Clinical Studies ( 14.5)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation Chemotherapy for AML
The recommended starting dosage of ZARXIO is 5 mcg/kg/day� administered as a single daily injection by subcutaneous injection� by short intravenous infusion (15 to 30 minutes)� or by continuous intravenous infusion. Obtain a complete blood count (CBC) and platelet count before instituting ZARXIO therapy and monitor twice weekly during therapy. Consider dose escalation in increments of 5 mcg/kg for each chemotherapy cycle� according to the duration and severity of the absolute neutrophil count (ANC) nadir. Recommend stopping ZARXIO if the ANC increases beyond 10�000/mm3 [see Warnings and Precautions (5.10)].
Administer ZARXIO at least 24 hours after cytotoxic chemotherapy. Do not administer ZARXIO within the 24-hour period prior to chemotherapy [see Warnings and Precautions ( 5.13)]. A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of ZARXIO therapy. Therefore, to ensure a sustained therapeutic response� administer ZARXIO daily for up to 2 weeks or until the ANC has reached 10�000/mm3 following the expected chemotherapy-induced neutrophil nadir. The duration of ZARXIO therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.
2.2 Dosage in Patients with Cancer Undergoing Bone Marrow Transplantation
The recommended dosage of ZARXIO following bone marrow transplantation (BMT) is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. Administer the first dose of ZARXIO at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion. Monitor CBCs and platelet counts frequently following marrow transplantation.
3 DOSAGE FORMS AND STRENGTHS

Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive� Needle Guard

Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive� Needle Guard
4 CONTRAINDICATIONS
ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products [see Warnings and Precautions ( 5.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture
Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
5.2 Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue ZARXIO in patients with ARDS.
DESCRIPTION
ZARXIO (filgrastim-sndz) is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.
ZARXIO is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. ZARXIO has a molecular weight of 18�800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis� except for the addition of an N-terminal methionine necessary for expression in E coli. Because ZARXIO is produced in E coli � the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation� differentiation commitment� and some end-cell functional activation.
Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes� fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation� differentiation, and selected end-cell functions (including enhanced phagocytic ability� priming of the cellular metabolism associated with respiratory burst� antibody-dependent killing, and the increased expression of some cell surface antigens). G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage.


item No.:RX740567 740567 NDC No.  61314-0318-10 61314031810 61314-318-10 6131431810 UPC/GTIN No. 361314-318107 3-61314-31810-7 361314318107 MPN 44876 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist
RX ITEM-Zarxio 300Mcg 0.5 Syringe 10X0.5
item No.:RX740567 740567 NDC No. 61314-0318-10 61314031810 61314-318-10 6131431810 UPC/GTIN No. 361314-318107 3-61314-31810-7 361314318107 MPN 44876 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist

BRAND: ZARXIO  NDC: 61314-0304-10,61314030410 UPC: 3-61314-30410-0,361314304100 ASD Specialty Healthcare-Special Order
Zarxio 300Mcg 0.5 Syringe 10X0.5Ml By AS
BRAND: ZARXIO NDC: 61314-0304-10,61314030410 UPC: 3-61314-30410-0,361314304100 ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
FILGRASTIM-SNDZ INJECTION
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop