Indicated for:

Patients with Cancer Receiving Myelosuppressive Chemotherapy:

• To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome:

• To increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available.

Use of the on-body Injector for Neulasta is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.

Use of the on-body Injector for Neulasta has not been studied in pediatric patients.

Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body Injector for Neulasta (this includes the 45-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta.

Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

MDS and AML have been associated with the use of Neulasta in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment.

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis has occurred in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy.

White blood cell (WBC) counts of 100 x 10⁹/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of complete blood count (CBC) during pegfilgrastim therapy is recommended.

Capillary leak syndrome has been reported after G-CSF administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.

The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Aortitis has been reported in patients receiving Neulasta. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count).

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. Animal studies: increased embryolethality and spontaneous abortions.

There are no data on the presence of pegfilgrastim in human milk, the effects on the  breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates.

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• Dosage greater than 6 mg per chemotherapy cycle for 4 cycles. GoToSource

• Adjunctive therapy for pneumonia. GoToSource 

• Parkinson’s disease. GoToSource 

• Adjunctive therapy for male patients with metastatic germ cell tumors. GoToSource

Increased risk of secondary malignancies. GoToSource

Bone pain. GoToSource

Glomerulonephritis (kidney inflammation). GoToSource

Hypersensitivity reactions. GoToSource

Hyperleukocytosis (white blood cell counts of 100 x 109/L or greater). GoToSource

Splenic rupture. GoToSource

Sickle cell crisis (sickle-shaped red blood cells block blood vessels causing severe pain). GoToSource

Sweet vasculitis (skin condition skin characterized by fever and painful red or purplish plaques or nodules), acute respiratory distress and sudden death. GoToSource  

Capillary leak syndrome (proteins leak out of tiny blood vessels and flow into surrounding tissues). GoToSource

Myelodysplastic syndrome (type of cancer in which the bone marrow does not make enough healthy blood cells) and acute myeloid leukemia (cancer of blood and bone marrow). GoToSource

Aortitis (inflammation of the aorta). GoToSource

Lawsuits filed for capillary leak syndrome.