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ZARXIO

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Overview

What is ZARXIO?

ZARXIO (filgrastim-sndz) is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.

ZARXIO is produced by () 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 . Because ZARXIO is produced in ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.

ZARXIO injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1.0 x 10 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose prefilled syringes. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-sndz. See Table 4 below for product composition of each single-dose prefilled syringe.

*quantity sufficient to make



What does ZARXIO look like?



What are the available doses of ZARXIO?

What should I talk to my health care provider before I take ZARXIO?

How should I use ZARXIO?

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 .

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/mm .

Administer ZARXIO at least 24 hours after cytotoxic chemotherapy. Do not administer ZARXIO within the 24-hour period prior to chemotherapy . 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/mm 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.


What interacts with ZARXIO?

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What are the warnings of ZARXIO?

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What are the precautions of ZARXIO?

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What are the side effects of ZARXIO?

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What should I look out for while using ZARXIO?

ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products .


What might happen if I take too much ZARXIO?

The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm have been reported in less than 5% of patients‚ but were not associated with any reported adverse clinical effects. Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects‚ although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.


How should I store and handle ZARXIO?

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 300 mcg/0.5 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Injection: Single-dose‚ preservative-free, prefilled syringes with an UltraSafe Passive Needle Guard, containing 480 mcg/0.8 mL of a clear, colorless to slightly yellowish filgrastim-sndz solution.Latex-sensitive individuals: The removable needle cap of ZARXIO prefilled syringe contains natural rubber latex which may cause allergic reaction. The safe use of ZARXIO in latex-sensitive individuals has not been studied.Storage:Store in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Avoid shaking. Protect from freezing. Prior to injection‚ ZARXIO may be allowed to reach room temperature for a maximum of 24 hours. Any prefilled syringe left above 25°C (77°F) for greater than 24 hours should be discarded.Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard ZARXIO if frozen more than once.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 or effects on the production or activity of hematopoietic cell types other than the neutrophil lineage.

Non-Clinical Toxicology
ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products .

Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine or procarbazine. Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative.

An interaction study between gentamicin and cytarabine showed a cytarabine related antagonism for the susceptibility of strains. This study suggests that in patients on cytarabine being treated with gentamicin for a infection, the lack of a prompt therapeutic response may indicate the need for reevaluation of antibacterial therapy.

Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine. This may be due to potential competitive inhibition of its uptake.

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.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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