Zarxio

— THERAPEUTIC CATEGORIES —
  • White blood cell disorders

Zarxio Generic Name & Formulations

General Description

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

Pharmacological Class

Granulocyte colony stimulating factor.

How Supplied

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

Manufacturer

Generic Availability

NO

Zarxio Indications

Indications

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).

Zarxio Dosage and Administration

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.

Zarxio Contraindications

Not Applicable

Zarxio Boxed Warnings

Not Applicable

Zarxio Warnings/Precautions

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 disorders (discontinue if sickle cell crisis occurs). Evaluate if glomerulonephritis is suspected; consider dose reduction or interruption if causality is likely. Monitor for MDS/AML in those with severe chronic neutropenia, breast or lung cancer. Hold dose if cutaneous vasculitis occurs; resume at reduced dose after symptoms resolve and the ANC decreased. Avoid simultaneous chemo- and radiation therapy. Aortitis (discontinue if suspected). Latex allergy. Pregnancy. Nursing mothers.

Zarxio Pharmacokinetics

See Literature

Zarxio Interactions

Interactions

May cause transient (+) bone-imaging results.

Zarxio Adverse Reactions

Adverse Reactions

Pyrexia, pain, rash, cough, dyspnea, epistaxis, bone pain, headache, anemia, diarrhea, hypoesthesia, alopecia; capillary leak syndrome, thrombocytopenia, leukocytosis, others (see full labeling).

Zarxio Clinical Trials

See Literature

Zarxio Note

Not Applicable

Zarxio Patient Counseling

See Literature