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ZARXIO
White blood cell disorders
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Drug Name:

ZARXIO Rx

Generic Name and Formulations:
Filgrastim-sndz 300mcg/0.5mL, 480mcg/0.8mL; for SC inj or IV infusion; preservative-free.

Company:
Sandoz

Therapeutic Use:

Indications for ZARXIO:

See full labeling. To decrease incidence of infection in patients with nonmyeloid malignancies receiving certain myelosuppressive anti-cancer drugs. To reduce time to neutrophil recovery and fever duration after induction or consolidation chemotherapy treatment of adults with AML. To reduce duration of neutropenia and related sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone-marrow transplantation (BMT). To mobilize hematopoietic progenitor cells (PBPC) into peripheral blood for collection by leukapheresis. To reduce the incidence and duration of neutropenia sequelae in severe chronic neutropenia (SCN).

Adult:

See full labeling. Do not give for at least 24hrs before or after cytotoxic chemotherapy dose. BMT: Give 1st dose at least 24hrs after bone marrow infusion. SCN: Give on a daily basis.

Children:

See full labeling.

Warnings/Precautions:

Monitor blood, including CBC and differential and platelets, before and during therapy (myelosuppressive chemotherapy: monitor twice weekly; BMT: monitor frequently; SCN: monitor during initial 4 weeks of therapy and during 2 weeks after dose adjustment) then monthly for the 1st year. Discontinue if post nadir absolute neutrophil count (ANC) reaches 10,000/mm3 for patients receiving myelosuppressive chemotherapy; other indications: see full labeling. Monitor for splenomegaly/splenic rupture and for acute respiratory distress syndrome (ARDS); discontinue if ARDS occurs. Confirm diagnosis and do appropriate pretreatment hematological workup in SCN. Permanently discontinue if serious allergic reactions occur. Sickle cell disease (may cause sickle cell crisis). Evaluate if glomerulonephritis is suspected; consider dose reduction or interruption if causality is likely. Abnormal cytogenetics or myelodysplastic syndrome. Chronic myeloid leukemia. Hold dose if cutaneous vasculitis occurs; resume at reduced dose after symptoms resolve and the ANC decreased. Avoid simultaneous chemo- and radiation therapy. Latex allergy. Pregnancy (Cat.C). Nursing mothers.

Interactions:

May cause transient (+) bone-imaging results.

Pharmacological Class:

Granulocyte colony stimulating factor.

Adverse Reactions:

Pyrexia, pain, rash, cough, dyspnea, epistaxis, bone pain, headache, anemia, diarrhea, hypoesthesia, alopecia; capillary leak syndrome (monitor), thrombocytopenia.

Generic Availability:

NO

How Supplied:

Single-use prefilled syringes (0.5mL, 0.8mL)—1, 10 (w. needle guard)

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