White blood cell disorders:

Indications for NIVESTYM:

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 ≥24hrs before or after cytotoxic chemotherapy dose. BMT: Give 1st dose ≥24hrs after bone marrow infusion. PBPC mobilization: Give ≥4 days before first leukapheresis and continue until the last leukapheresis. 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 following transplantation; SCN: monitor during initial 4 weeks of therapy and during 2 weeks after dose adjustment, then monthly once clinically stable). Discontinue if post nadir absolute neutrophil count (ANC) >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 develops. Confirm diagnosis and do appropriate pretreatment hematological workup in SCN. Sickle cell disease: may cause severe sickle cell crisis (discontinue if occurs). Consider reducing or interrupting dose if glomerulonephritis suspected. Monitor for signs/symptoms of aortitis; discontinue if suspected. Avoid simultaneous chemo- and radiation therapy. Withhold therapy if cutaneous vasculitis occurs; resume at lower dose when resolved. Permanently discontinue if serious allergic reactions occur. PBPC mobilization: not for use in healthy donors. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.

Pharmacologic Class:

Granulocyte colony stimulating factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Prefilled syringes (0.5mL, 0.8mL)—1, 10; Vials (1mL, 1.6mL)—10

Pricing for NIVESTYM

0.5ml of 300mcg syringe (Qty: 10)
Appx. price $2177
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