• White blood cell disorders

Nivestym Generic Name & Formulations

General Description

Filgrastim-aafi 300mcg, 480mcg; soln for SC inj or IV infusion; preservative-free.

Pharmacological Class

Granulocyte colony stimulating factor.

How Supplied

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


Generic Availability


Nivestym 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).

Nivestym Dosage and Administration


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.


See full labeling.

Nivestym Contraindications

Not Applicable

Nivestym Boxed Warnings

Not Applicable

Nivestym 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 MDS/AML in those with severe chronic neutropenia, breast or lung cancer. Monitor for 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.

Nivestym Pharmacokinetics

See Literature

Nivestym Interactions

Nivestym Adverse Reactions

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).

Nivestym Clinical Trials

See Literature

Nivestym Note

Not Applicable

Nivestym Patient Counseling

See Literature